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Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
celecoxib
cyclophosphamide
etoposide
thalidomide
Sponsored by
Dana-Farber Cancer Institute
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 anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, adult mixed glioma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed intracranial malignant glioma, including glioblastoma multiforme, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant astrocytoma not otherwise specified Unequivocal evidence of relapsed or refractory disease by MRI or CT scan and/or tumor resection Steroid therapy prior to MRI or CT scan must have been at a stable dose for at least 5 days Failed prior radiotherapy Must have confirmation of true progression rather than radiation necrosis if previously treated with interstitial brachytherapy or stereotactic radiosurgery PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy More than 2 months Hematopoietic Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin greater than 9 g/dL No history of bleeding disorder Hepatic Bilirubin less than 1.5 mg/dL SGPT less than 2.5 times normal Alkaline phosphatase less than 2.5 times normal Renal Creatinine less than 1.5 times upper limit of normal (ULN) OR BUN less than 1.5 times ULN Cardiovascular No deep vein thrombosis within the past 3 weeks (must be clinically stable) Pulmonary No pulmonary embolism within the past 3 weeks (must be clinically stable) Other No peripheral neuropathy grade 2 or greater No active infection No other serious concurrent medical illness No concurrent illness that may obscure toxicity or dangerously alter drug metabolism No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix Must participate in the System for Thalidomide Education and Prescribing Safety program Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 forms of effective contraception for 1 month before, during, and for 1 month after study PRIOR CONCURRENT THERAPY: Biologic therapy No prior oral thalidomide or celecoxib for more than 2 months duration Chemotherapy No prior oral etoposide or cyclophosphamide for more than 2 months duration Prior standard-dose IV etoposide and cyclophosphamide allowed Endocrine therapy See Disease Characteristics Concurrent steroids allowed Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery See Disease Characteristics Prior surgery for relapsed or refractory disease allowed Recovered from prior surgery No concurrent surgery Other No other concurrent investigational agents or treatment No other concurrent anticancer therapy Concurrent antiseizure medications allowed

Sites / Locations

  • Massachusetts General Hospital Cancer Center
  • Brigham and Women's Hospital
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 3, 2002
Last Updated
July 6, 2017
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI), Schering-Plough, Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT00047281
Brief Title
Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma
Official Title
Trial Of Oral Thalidomide, Celecoxib, Etoposide And Cyclophosphamide In Adult Patients With Relapsed Or Progressive Malignant Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 2004 (Actual)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI), Schering-Plough, Celgene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Thalidomide and celecoxib may stop the growth of tumor cells 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 and celecoxib with etoposide and cyclophosphamide may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and celecoxib with etoposide and cyclophosphamide in treating patients who have relapsed or refractory malignant glioma.
Detailed Description
OBJECTIVES: Determine the efficacy of thalidomide, celecoxib, etoposide, and cyclophosphamide, in terms of 6-month progression-free survival, in patients with relapsed or refractory malignant glioma. Determine the overall survival of patients treated with this regimen. Determine the toxic effects of this regimen in these patients. Determine the radiographic response in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral thalidomide once daily and oral celecoxib twice daily on days 1-42, oral etoposide once daily on days 1-21, and oral cyclophosphamide once daily on days 22-42. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 48 patients (32 with glioblastoma multiforme and 16 with anaplastic glioma) will be accrued for this study within 2 years.

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 anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, adult mixed glioma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
celecoxib
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
thalidomide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed intracranial malignant glioma, including glioblastoma multiforme, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant astrocytoma not otherwise specified Unequivocal evidence of relapsed or refractory disease by MRI or CT scan and/or tumor resection Steroid therapy prior to MRI or CT scan must have been at a stable dose for at least 5 days Failed prior radiotherapy Must have confirmation of true progression rather than radiation necrosis if previously treated with interstitial brachytherapy or stereotactic radiosurgery PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy More than 2 months Hematopoietic Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin greater than 9 g/dL No history of bleeding disorder Hepatic Bilirubin less than 1.5 mg/dL SGPT less than 2.5 times normal Alkaline phosphatase less than 2.5 times normal Renal Creatinine less than 1.5 times upper limit of normal (ULN) OR BUN less than 1.5 times ULN Cardiovascular No deep vein thrombosis within the past 3 weeks (must be clinically stable) Pulmonary No pulmonary embolism within the past 3 weeks (must be clinically stable) Other No peripheral neuropathy grade 2 or greater No active infection No other serious concurrent medical illness No concurrent illness that may obscure toxicity or dangerously alter drug metabolism No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix Must participate in the System for Thalidomide Education and Prescribing Safety program Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 forms of effective contraception for 1 month before, during, and for 1 month after study PRIOR CONCURRENT THERAPY: Biologic therapy No prior oral thalidomide or celecoxib for more than 2 months duration Chemotherapy No prior oral etoposide or cyclophosphamide for more than 2 months duration Prior standard-dose IV etoposide and cyclophosphamide allowed Endocrine therapy See Disease Characteristics Concurrent steroids allowed Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery See Disease Characteristics Prior surgery for relapsed or refractory disease allowed Recovered from prior surgery No concurrent surgery Other No other concurrent investigational agents or treatment No other concurrent anticancer therapy Concurrent antiseizure medications allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Y. Wen, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma

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