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

• Status: Completed
• Trial end date: 2006-03-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest Baptist Health; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Procarbazine; Thalidomide

Criteria

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