Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma

Study Overview
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Brief Summary
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RATIONALE: Thalidomide may stop the growth of malignant glioma by stopping blood flow to the tumor. Drugs used in chemotherapy, such as procarbazine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with procarbazine may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving thalidomide together with procarbazine works in treating patients with recurrent or progressive malignant glioma.

Detailed Description
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OBJECTIVES: Primary Determine the response rate in patients with recurrent or progressive malignant glioma treated with thalidomide and procarbazine. Secondary Determine the progression-free survival of patients treated with this regimen. Determine the overall survival of patients treated with this regimen. Determine the quality of life of patients treated with this regimen. Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oral procarbazine once daily on days 1-5 and oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then before every odd course. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 23-55 patients will be accrued for this study.

Official Title
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A Phase II Trial Of Thalidomide And Procarbazine In Adults With Recurrent/Progressive Gliomas

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: procarbazine hydrochloride
* Drug: thalidomide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed malignant glioma Anaplastic astrocytoma Anaplastic oligodendroglioma Glioblastoma multiforme Anaplastic mixed oligoastrocytoma Progressive or recurrent disease* after radiotherapy with or without chemotherapy NOTE: *Patients with prior low-grade glioma who progressed after therapy and are found to have high-grade glioma are eligible Measurable disease by MRI or CT scan PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy More than 2 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 mg/dL Transaminases ≤ 4 times upper limit of normal Renal Creatinine ≤ 1.7 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use 1 highly active method and 1 additional effective method of contraception for 1 month before, during, and for 4 weeks after study treatment No concurrent serious infection No other concurrent medical illness that would preclude study treatment No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy No prior thalidomide No concurrent prophylactic filgrastim (G-CSF) Chemotherapy See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) No prior procarbazine No more than 2 prior chemotherapy regimens for malignant glioma Endocrine therapy Not specified Radiotherapy See Disease Characteristics At least 3 months since prior radiotherapy Other Recovered from prior therapy More than 7 days since prior antidepressants (selective serotonin reuptake inhibitors and/or monamine oxidase inhibitors) No concurrent antidepressants No other concurrent investigational agents

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: procarbazine hydrochloride|nan|
|Drug: thalidomide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate by CT scan and MRI at baseline, pre-odd cycles, and study completion |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival by CT scan, MRI, and follow up form at baseline, pre-odd cycles, and study completion |  |  | 
| Overall survival by follow-up form at study completion |  |  | 
| Quality of life by FACT-Br, FACIT-F and Karnofsky performance status (PS) at baseline, pre-odd cycles, and study completion |  |  | 
| Toxicity by evaluation form at baseline, pre-odd cycles, and study completion |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent adult brain tumor, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, adult mixed glioma, adult giant cell glioblastoma, adult gliosarcoma