Temozolomide Plus Thalidomide in Treating Patients With Recurrent or Progressive Brain Tumor
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| ClinicalTrials.gov Identifier: NCT00006358 |
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Recruitment Status :
Completed
First Posted : May 26, 2004
Last Update Posted : June 26, 2018
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and thalidomide in treating patients who have recurrent or progressive brain tumor.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Brain and Central Nervous System Tumors | Drug: temozolomide Drug: thalidomide | Phase 2 |
OBJECTIVES: I. Determine the efficacy of temozolomide and thalidomide in patients with recurrent or progressive supratentorial glioblastoma multiforme or gliosarcoma. II. Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive oral temozolomide once daily on days 1-5 and oral thalidomide daily on days 1-28. Treatment repeats every 28 days for a maximum of 24 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month and then for survival.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4-5 months.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 44 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Evaluation of Temozolomide (SCH52365) and Thalidomide for the Treatment of Recurrent and Progressive Glioblastoma Multiforme |
| Actual Study Start Date : | June 13, 2000 |
| Actual Primary Completion Date : | January 23, 2003 |
| Actual Study Completion Date : | July 20, 2006 |
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| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed supratentorial glioblastoma multiforme or gliosarcoma Must have evidence of tumor recurrence or progression by MRI scan after failing prior radiotherapy Bidimensionally measurable enhancing residual disease on MRI or CT scan Prior recent resection of recurrent or progressive tumor allowed if all of the following conditions apply: Recovered from surgery Residual evaluable disease present that is not artifactual postsurgical enhancement Baseline MRI or CT scan is performed within 14 days prior to study and while on a steroid dose that has been stable for at least 5-7 days
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGPT less than 2 times normal Alkaline phosphatase less than 2 times normal Bilirubin less than 1.5 mg/dL Renal: BUN or creatinine less than 1.5 times normal Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use one highly effective method of contraception, AND one additional effective method of contraception for at least 4 weeks before, during, and for 8 weeks after study No peripheral neuropathy greater than grade 1 No active infection No other illness that would obscure toxicity or alter drug metabolism No other concurrent serious medical illness No other prior cancer within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior thalidomide No other concurrent biologic therapy for cancer Chemotherapy: No more than 1 prior chemotherapy regimen At least 3 weeks since prior chemotherapy (2 weeks for vincristine and 6 weeks for nitrosoureas) No other concurrent chemotherapy for cancer Endocrine therapy: See Disease Characteristics No concurrent endocrine therapy for cancer Radiotherapy: See Disease Characteristics No concurrent radiotherapy for cancer Surgery: See Disease Characteristics No concurrent surgery for cancer Other: Recovered from prior therapy No other concurrent investigational drugs for cancer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006358
| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| UCSF Cancer Center and Cancer Research Institute | |
| San Francisco, California, United States, 94115-0128 | |
| United States, Maryland | |
| Neuro-Oncology Branch | |
| Bethesda, Maryland, United States, 20892 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0752 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| United States, Pennsylvania | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Texas | |
| Simmons Cancer Center - Dallas | |
| Dallas, Texas, United States, 75235-9154 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-7811 | |
| United States, Wisconsin | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792 | |
| Study Chair: | Morris D. Groves, MD, JD | M.D. Anderson Cancer Center |
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| ClinicalTrials.gov Identifier: | NCT00006358 |
| Other Study ID Numbers: |
NABTC-9904 CDR0000068227 ( Registry Identifier: PDQ (Physician Data Query) ) |
| First Posted: | May 26, 2004 Key Record Dates |
| Last Update Posted: | June 26, 2018 |
| Last Verified: | June 2018 |
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recurrent adult brain tumor adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
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Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Thalidomide |
Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |