Back to resultsTemozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme
Primary Purpose
Brain and Central Nervous System Tumors, Glioblastoma Multiforme
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Celecoxib
Isotretinoin
Temozolomide
Thalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult giant cell glioblastoma, adult gliosarcoma, adult glioblastoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed supratentorial glioblastoma multiforme Must have undergone a biopsy OR subtotal or gross total resection of the tumor Must have completed post-operative (or post-biopsy) radiotherapy within the past 5 weeks No progressive disease after radiotherapy PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Serum glutamate pyruvate transaminase (SGPT) < 2 times upper limit of normal (ULN) Alkaline phosphatase < 2 times ULN Bilirubin ≤ 1.5 mg/dL Renal blood urea nitrogen (BUN) ≤ 1.5 times ULN Creatinine ≤ 1.5 times ULN Immunologic No history of allergic reactions attributed to compounds of similar chemical or biological composition to celecoxib or to sulfonamides No asthma, urticaria, or allergic reactions to aspirin or other NSAIDs No active infection Gastrointestinal No inflammatory bowel disease No history of peptic ulcer disease No gastrointestinal bleeding within past 3 months Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double-method contraception during and for 2 months after study participation Fertile female patients randomized to receive thalidomide must use effective double-method contraception for ≥ 4 weeks before, during, and ≥ 4 weeks after completion of study therapy Fertile male patients randomized to receive thalidomide must use effective contraception during and for ≥ 4 weeks after completion of study therapy No blood donation (for patients randomized to receive thalidomide) No history of any other cancer except nonmelanoma skin cancer or carcinoma in situ of the cervix or cancer that is in complete remission and patient completed all therapy for that disease ≥ 3 years ago No other disease that would obscure toxicity or dangerously alter drug metabolism (e.g., severe connective tissue disease) No other serious medical illness PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Prior temozolomide in combination with radiotherapy allowed No other prior or concurrent chemotherapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics See Chemotherapy Surgery See Disease Characteristics No concurrent surgery Other No other concurrent non-steroidal anti-inflammatory drugs (NSAIDs) (for patients randomized to receive celecoxib) No other concurrent investigational drugs No other concurrent anticancer therapy
Sites / Locations
- Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
- University of Texas MD Anderson Cancer Center at Orlando
- CCOP - Atlanta Regional
- CCOP - Central Illinois
- CCOP - Wichita
- CCOP - Grand Rapids
- CCOP - Kalamazoo
- CCOP - Kansas City
- Cancer Research for the Ozarks
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
- CCOP - Upstate Carolina
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Arm I: TMZ
Arm II: TMZ + Thalidomide
Arm III: TMZ + Isotretinoin
Arm IV: TMZ + Celecoxib
Arm V: TMZ + Thalidomide + Isotretinoin
Arm VI: TMZ + Thalidomide + Celecoxib
Arm VII: TMZ + Isotretinoin + Celecoxib
Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib
Arm Description
Oral Temozolomide (TMZ) 150 mg/m^2 once daily on days 1-7 and 15-21.
Temozolomide as in arm I and oral Thalidomide (Thal) once daily on days 1-28 (starting dose 200 mg).
Temozolomide as in Arm I and oral Isotretinoin 40 mg/m^2 twice daily on days 1-21.
Temozolomide as in arm I and oral Celecoxib 400 mg twice daily on days 1-28.
Temozolomide as in arm I, Thalidomide as in arm II, and Isotretinoin as in arm III.
Temozolomide as in Arm I, Thalidomide as in Arm II, and Celecoxib as in Arm IV.
Temozolomide as in Arm I, Isotretinoin as in Arm III, and Celecoxib as in Arm IV.
Temozolomide as in Arm I, Thalidomide as in Arm II, Isotretinoin as in Arm III, and Celecoxib as in Arm IV.
Outcomes
Primary Outcome Measures
Median Progression-Free Survival (PFS) Comparison of Thalidomide Arms Versus no Thalidomide Arms
Thalidomide versus not Thalidomide analysis: Comparison of median PFS outcome of participants in arms II, VI, VII and VIII, versus participants in arms I, III, IV and V. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Median Progression-Free Survival (PFS) Comparison of Celecoxib Arms Versus no Celecoxib Arms
Celecoxib versus not Celecoxib analysis: We compared the median PFS outcome of participants in arms III, V, VI and VIII, versus participants in arms I, II, IV and VII. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Median Progression-Free Survival (PFS) Comparison of Isotretinoin Arms Versus no Isotretinoin Arms
Isotretinoin versus not Isotretinoin analysis: We compared the median PFS outcome of participants in arms IV, V, VII and VIII, versus participants in arms I, II, III and VI. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Secondary Outcome Measures
Median Progression-Free Survival (PFS) Comparison of Doublet Versus Triplet Therapy
Doublet (2 agents) versus Triplet (3 agents) therapy analysis: We compared the median PFS outcome of participants in arms II, III, IV, versus participants in arms V, VI and VII. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Median Progression-Free Survival (PFS) of Individual Arms
Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Median Overall Survival (OS) Comparison of Thalidomide Arms Versus no Thalidomide Arms
Thalidomide versus not Thalidomide analysis: We compared the median OS outcome of participants in arms II, VI, VII and VIII, versus participants in arms I, III, IV and V. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Median Overall Survival (OS) Comparison of Celecoxib Arms Versus no Celecoxib Arms
Celecoxib versus not Celecoxib analysis: We compared the median OS outcome of participants in arms III, V, VI and VIII, versus participants in arms I, II, IV and VII. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Median Overall Survival (OS) Comparison of Isotretinoin Arms Versus no Isotretinoin Arms
Isotretinoin versus not Isotretinoin analysis: We compared the median OS outcome of participants in arms IV, V, VII and VIII, versus participants in arms I, II, III and VI. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Median Overall Survival (OS) Comparison of Doublet Versus Triplet Therapy
Doublet (2 agents) versus Triplet (3 agents) therapy analysis: We compared the median OS outcome of participants in arms II, III, IV, versus participants in arms V, VI and VII. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Overall Survival of Individual Arms
Overall Survival (OS) was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Full Information
NCT ID
NCT00112502
First Posted
June 2, 2005
Last Updated
September 21, 2021
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00112502
Brief Title
Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme
Official Title
A Randomized, Factorial-Design, Phase II Trial of Temozolomide Alone and in Combination With Possible Permutations of Thalidomide, Isotretinoin and/or Celecoxib as Post-Radiation Adjuvant Therapy of Glioblastoma Multiforme
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of glioblastoma multiforme by blocking blood flow to the tumor. Isotretinoin may help cells that are involved in the body's immune response to work better. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known which temozolomide-containing regimen is more effective in treating glioblastoma multiforme.
PURPOSE: This randomized phase II trial is studying eight different temozolomide-containing regimens to compare how well they work in treating patients who have undergone radiation therapy for glioblastoma multiforme.
Detailed Description
OBJECTIVES:
Compare the efficacy of adjuvant temozolomide (TMZ) alone or in combination with thalidomide and/or isotretinoin and/or celecoxib, in terms of 6-month progression-free survival, in patients who have undergone radiotherapy for supratentorial glioblastoma multiforme.
Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 8 treatment arms.
Arm I: Patients receive oral temozolomide once daily on days 1-7 and 15-21.
Arm II: Patients receive temozolomide as in arm I and oral thalidomide once daily on days 1-28.
Arm III: Patients receive temozolomide as in arm I and oral isotretinoin twice daily on days 1-21.
Arm IV: Patients receive temozolomide as in arm I and oral celecoxib twice daily on days 1-28.
Arm V: Patients receive temozolomide as in arm I, thalidomide as in arm II, and isotretinoin as in arm III.
Arm VI: Patients receive temozolomide as in arm I, thalidomide as in arm II, and celecoxib as in arm IV.
Arm VII: Patients receive temozolomide as in arm I, isotretinoin as in arm III, and celecoxib as in arm IV.
Arm VIII: Patients receive temozolomide as in arm I, thalidomide as in arm II, isotretinoin as in arm III, and celecoxib as in arm IV.
In all arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patient may receive additional courses of therapy at the discretion of the treating physician.
After completion of study treatment, patients are followed for at least 30 days and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Glioblastoma Multiforme
Keywords
adult giant cell glioblastoma, adult gliosarcoma, adult glioblastoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
178 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I: TMZ
Arm Type
Active Comparator
Arm Description
Oral Temozolomide (TMZ) 150 mg/m^2 once daily on days 1-7 and 15-21.
Arm Title
Arm II: TMZ + Thalidomide
Arm Type
Experimental
Arm Description
Temozolomide as in arm I and oral Thalidomide (Thal) once daily on days 1-28 (starting dose 200 mg).
Arm Title
Arm III: TMZ + Isotretinoin
Arm Type
Experimental
Arm Description
Temozolomide as in Arm I and oral Isotretinoin 40 mg/m^2 twice daily on days 1-21.
Arm Title
Arm IV: TMZ + Celecoxib
Arm Type
Experimental
Arm Description
Temozolomide as in arm I and oral Celecoxib 400 mg twice daily on days 1-28.
Arm Title
Arm V: TMZ + Thalidomide + Isotretinoin
Arm Type
Experimental
Arm Description
Temozolomide as in arm I, Thalidomide as in arm II, and Isotretinoin as in arm III.
Arm Title
Arm VI: TMZ + Thalidomide + Celecoxib
Arm Type
Experimental
Arm Description
Temozolomide as in Arm I, Thalidomide as in Arm II, and Celecoxib as in Arm IV.
Arm Title
Arm VII: TMZ + Isotretinoin + Celecoxib
Arm Type
Experimental
Arm Description
Temozolomide as in Arm I, Isotretinoin as in Arm III, and Celecoxib as in Arm IV.
Arm Title
Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib
Arm Type
Experimental
Arm Description
Temozolomide as in Arm I, Thalidomide as in Arm II, Isotretinoin as in Arm III, and Celecoxib as in Arm IV.
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
Celebrex
Intervention Description
400 mg orally twice a day continuous dosing
Intervention Type
Drug
Intervention Name(s)
Isotretinoin
Other Intervention Name(s)
Accutane, 13-Cis-Retinoic Acid
Intervention Description
40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Other Intervention Name(s)
Temodar
Intervention Description
150 mg/m2 orally daily, 7 days on treatment, 7 days off.
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Other Intervention Name(s)
Thalomid
Intervention Description
400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)
Primary Outcome Measure Information:
Title
Median Progression-Free Survival (PFS) Comparison of Thalidomide Arms Versus no Thalidomide Arms
Description
Thalidomide versus not Thalidomide analysis: Comparison of median PFS outcome of participants in arms II, VI, VII and VIII, versus participants in arms I, III, IV and V. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time Frame
Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up, up to one year (12 study cycles).
Title
Median Progression-Free Survival (PFS) Comparison of Celecoxib Arms Versus no Celecoxib Arms
Description
Celecoxib versus not Celecoxib analysis: We compared the median PFS outcome of participants in arms III, V, VI and VIII, versus participants in arms I, II, IV and VII. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time Frame
Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up.
Title
Median Progression-Free Survival (PFS) Comparison of Isotretinoin Arms Versus no Isotretinoin Arms
Description
Isotretinoin versus not Isotretinoin analysis: We compared the median PFS outcome of participants in arms IV, V, VII and VIII, versus participants in arms I, II, III and VI. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time Frame
Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up.
Secondary Outcome Measure Information:
Title
Median Progression-Free Survival (PFS) Comparison of Doublet Versus Triplet Therapy
Description
Doublet (2 agents) versus Triplet (3 agents) therapy analysis: We compared the median PFS outcome of participants in arms II, III, IV, versus participants in arms V, VI and VII. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time Frame
Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up.
Title
Median Progression-Free Survival (PFS) of Individual Arms
Description
Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time Frame
Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up.
Title
Median Overall Survival (OS) Comparison of Thalidomide Arms Versus no Thalidomide Arms
Description
Thalidomide versus not Thalidomide analysis: We compared the median OS outcome of participants in arms II, VI, VII and VIII, versus participants in arms I, III, IV and V. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time Frame
Every 3 months from randomization until progression of disease, death or last follow-up.
Title
Median Overall Survival (OS) Comparison of Celecoxib Arms Versus no Celecoxib Arms
Description
Celecoxib versus not Celecoxib analysis: We compared the median OS outcome of participants in arms III, V, VI and VIII, versus participants in arms I, II, IV and VII. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time Frame
Every 3 months from randomization until progression of disease, death or last follow-up.
Title
Median Overall Survival (OS) Comparison of Isotretinoin Arms Versus no Isotretinoin Arms
Description
Isotretinoin versus not Isotretinoin analysis: We compared the median OS outcome of participants in arms IV, V, VII and VIII, versus participants in arms I, II, III and VI. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time Frame
Every 3 months from randomization until progression of disease, death or last follow-up.
Title
Median Overall Survival (OS) Comparison of Doublet Versus Triplet Therapy
Description
Doublet (2 agents) versus Triplet (3 agents) therapy analysis: We compared the median OS outcome of participants in arms II, III, IV, versus participants in arms V, VI and VII. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time Frame
Every 3 months from randomization until progression of disease, death or last follow-up.
Title
Overall Survival of Individual Arms
Description
Overall Survival (OS) was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time Frame
Every 3 months from randomization until progression of disease, death or last follow-up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed supratentorial glioblastoma multiforme
Must have undergone a biopsy OR subtotal or gross total resection of the tumor
Must have completed post-operative (or post-biopsy) radiotherapy within the past 5 weeks
No progressive disease after radiotherapy
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
Karnofsky 60-100%
Life expectancy
Not specified
Hematopoietic
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hepatic
Serum glutamate pyruvate transaminase (SGPT) < 2 times upper limit of normal (ULN)
Alkaline phosphatase < 2 times ULN
Bilirubin ≤ 1.5 mg/dL
Renal
blood urea nitrogen (BUN) ≤ 1.5 times ULN
Creatinine ≤ 1.5 times ULN
Immunologic
No history of allergic reactions attributed to compounds of similar chemical or biological composition to celecoxib or to sulfonamides
No asthma, urticaria, or allergic reactions to aspirin or other NSAIDs
No active infection
Gastrointestinal
No inflammatory bowel disease
No history of peptic ulcer disease
No gastrointestinal bleeding within past 3 months
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective double-method contraception during and for 2 months after study participation
Fertile female patients randomized to receive thalidomide must use effective double-method contraception for ≥ 4 weeks before, during, and ≥ 4 weeks after completion of study therapy
Fertile male patients randomized to receive thalidomide must use effective contraception during and for ≥ 4 weeks after completion of study therapy
No blood donation (for patients randomized to receive thalidomide)
No history of any other cancer except nonmelanoma skin cancer or carcinoma in situ of the cervix or cancer that is in complete remission and patient completed all therapy for that disease ≥ 3 years ago
No other disease that would obscure toxicity or dangerously alter drug metabolism (e.g., severe connective tissue disease)
No other serious medical illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
Prior temozolomide in combination with radiotherapy allowed
No other prior or concurrent chemotherapy
Endocrine therapy
Not specified
Radiotherapy
See Disease Characteristics
See Chemotherapy
Surgery
See Disease Characteristics
No concurrent surgery
Other
No other concurrent non-steroidal anti-inflammatory drugs (NSAIDs) (for patients randomized to receive celecoxib)
No other concurrent investigational drugs
No other concurrent anticancer therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Penas-Prado, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72913
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center at Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806-2134
Country
United States
Facility Name
CCOP - Atlanta Regional
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-1701
Country
United States
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
CCOP - Grand Rapids
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20729242
Citation
Gilbert MR, Gonzalez J, Hunter K, Hess K, Giglio P, Chang E, Puduvalli V, Groves MD, Colman H, Conrad C, Levin V, Woo S, Mahajan A, de Groot J, Yung WK. A phase I factorial design study of dose-dense temozolomide alone and in combination with thalidomide, isotretinoin, and/or celecoxib as postchemoradiation adjuvant therapy for newly diagnosed glioblastoma. Neuro Oncol. 2010 Nov;12(11):1167-72. doi: 10.1093/neuonc/noq100. Epub 2010 Aug 20.
Results Reference
result
PubMed Identifier
25239666
Citation
Penas-Prado M, Hess KR, Fisch MJ, Lagrone LW, Groves MD, Levin VA, De Groot JF, Puduvalli VK, Colman H, Volas-Redd G, Giglio P, Conrad CA, Salacz ME, Floyd JD, Loghin ME, Hsu SH, Gonzalez J, Chang EL, Woo SY, Mahajan A, Aldape KD, Yung WK, Gilbert MR; MD Anderson Community Clinical Oncology Program; Brain Tumor Trials Collaborative. Randomized phase II adjuvant factorial study of dose-dense temozolomide alone and in combination with isotretinoin, celecoxib, and/or thalidomide for glioblastoma. Neuro Oncol. 2015 Feb;17(2):266-73. doi: 10.1093/neuonc/nou155. Epub 2014 Sep 19.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
University of Texas (UT) MD Anderson Cancer Center Official Website
Learn more about this trial
Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme
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