Phase II Evaluation of Temozolomide (SCH52365) and Thalidomide for the Treatment of Recurrent and Progressive Glioblastoma Multiforme

Inclusion Criteria

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