search
Back to results

Thalidomide and Irinotecan in Treating Patients With Glioblastoma Multiforme Who Have Undergone Radiation Therapy

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
irinotecan hydrochloride
thalidomide
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme (GBM) Recurrent disease allowed Evaluable disease on contrast-enhanced MRI Prior external beam radiotherapy required PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 5 times ULN Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min Cardiovascular: No significant cardiac disease No uncontrolled high blood pressure No unstable angina No congestive heart failure No myocardial infarction within the past 3 months No serious cardiac arrhythmias Gastrointestinal: Able to take oral medication No gastrointestinal abnormalities No requirement for IV alimentation No active peptic ulcer disease Other: No active infection No serious uncontrolled medical disorder No dementia or significantly altered mental status that would preclude study No known hypersensitivity to irinotecan or thalidomide Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 forms of effective contraception, including 1 highly effective method, at least 1 month before, during, and for 1 month after study PRIOR CONCURRENT THERAPY: Biologic therapy: No prior thalidomide Chemotherapy: No prior irinotecan At least 4 weeks since other prior chemotherapy (and demonstrated evidence of disease progression or relapse) Endocrine therapy: Concurrent corticosteroids allowed if on a stable or decreasing dose for at least 1 week prior to study No concurrent hormonal therapy for GBM Radiotherapy: See Disease Characteristics No concurrent radiotherapy for GBM Surgery: No prior surgical procedures affecting absorption Other: No other concurrent anticancer investigational agents for GBM No concurrent cytochrome P450 inhibitors, including the following: Nefazodone Fluvoxamine Fluoxetine Sertraline Paroxetine Venlafaxine Ketoconazole Itraconazole Fluconazole Cimetadine Clarithromycin Diltiazem Erythromycin Protease inhibitors

Sites / Locations

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Outcomes

Primary Outcome Measures

Response
To evaluate the response rate and hence preliminary efficacy of Irinotecan and Thalidomide following radiotherapy in the treatment of newly diagnosed or relapsed glioblastoma multiforme.

Secondary Outcome Measures

Toxicity / QOL / Survival
To evaluate 1) toxicity 2) quality of life 3) disease free survival and 4) overall survival of patients treated with this combination.

Full Information

First Posted
June 6, 2002
Last Updated
October 26, 2011
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00039468
Brief Title
Thalidomide and Irinotecan in Treating Patients With Glioblastoma Multiforme Who Have Undergone Radiation Therapy
Official Title
A Phase II Study Of Thalidomide And CPT-11 (IRINOTECAN) Following Radiotherapy For Glioblastoma Multiforme
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Thalidomide may stop the growth of glioblastoma multiforme by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with irinotecan may kill any tumor cells remaining after radiation therapy. PURPOSE: Phase II trial to study the effectiveness of combining thalidomide with irinotecan in treating patients who have glioblastoma multiforme that has been treated with radiation therapy.
Detailed Description
OBJECTIVES: Determine the response rate of patients with glioblastoma multiforme treated with thalidomide and irinotecan after radiotherapy. Determine the preliminary efficacy of this regimen in these patients. Determine the disease-free survival and overall survival of patients treated with this regimen. Determine the toxicity of this regimen in these patients. Assess the quality of life of patients treated with this regimen. OUTLINE: Beginning 2-4 weeks after completion of radiotherapy, patients receive irinotecan IV over 90 minutes on day 1. Patients also receive oral thalidomide daily. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, 1 week after the first course, prior to all subsequent courses, and then after course 6. Patients are followed for 5 years. PROJECTED ACCRUAL: A total of 9-24 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
Keywords
adult glioblastoma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Other Intervention Name(s)
CAMPTOSAR
Intervention Description
350 or 700 mg/m2 IV every 3 weeks
Intervention Type
Drug
Intervention Name(s)
thalidomide
Other Intervention Name(s)
THALOMID
Intervention Description
400mg/day oral
Primary Outcome Measure Information:
Title
Response
Description
To evaluate the response rate and hence preliminary efficacy of Irinotecan and Thalidomide following radiotherapy in the treatment of newly diagnosed or relapsed glioblastoma multiforme.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Toxicity / QOL / Survival
Description
To evaluate 1) toxicity 2) quality of life 3) disease free survival and 4) overall survival of patients treated with this combination.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme (GBM) Recurrent disease allowed Evaluable disease on contrast-enhanced MRI Prior external beam radiotherapy required PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 5 times ULN Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min Cardiovascular: No significant cardiac disease No uncontrolled high blood pressure No unstable angina No congestive heart failure No myocardial infarction within the past 3 months No serious cardiac arrhythmias Gastrointestinal: Able to take oral medication No gastrointestinal abnormalities No requirement for IV alimentation No active peptic ulcer disease Other: No active infection No serious uncontrolled medical disorder No dementia or significantly altered mental status that would preclude study No known hypersensitivity to irinotecan or thalidomide Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 forms of effective contraception, including 1 highly effective method, at least 1 month before, during, and for 1 month after study PRIOR CONCURRENT THERAPY: Biologic therapy: No prior thalidomide Chemotherapy: No prior irinotecan At least 4 weeks since other prior chemotherapy (and demonstrated evidence of disease progression or relapse) Endocrine therapy: Concurrent corticosteroids allowed if on a stable or decreasing dose for at least 1 week prior to study No concurrent hormonal therapy for GBM Radiotherapy: See Disease Characteristics No concurrent radiotherapy for GBM Surgery: No prior surgical procedures affecting absorption Other: No other concurrent anticancer investigational agents for GBM No concurrent cytochrome P450 inhibitors, including the following: Nefazodone Fluvoxamine Fluoxetine Sertraline Paroxetine Venlafaxine Ketoconazole Itraconazole Fluconazole Cimetadine Clarithromycin Diltiazem Erythromycin Protease inhibitors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camilo E. Fadul, MD
Organizational Affiliation
Norris Cotton Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18661102
Citation
Fadul CE, Kingman LS, Meyer LP, Cole BF, Eskey CJ, Rhodes CH, Roberts DW, Newton HB, Pipas JM. A phase II study of thalidomide and irinotecan for treatment of glioblastoma multiforme. J Neurooncol. 2008 Nov;90(2):229-35. doi: 10.1007/s11060-008-9655-9. Epub 2008 Jul 26.
Results Reference
result

Learn more about this trial

Thalidomide and Irinotecan in Treating Patients With Glioblastoma Multiforme Who Have Undergone Radiation Therapy

We'll reach out to this number within 24 hrs