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 I trial to study the effectiveness of combining topotecan and thalidomide in treating patients who have recurrent or refractory malignant glioma.

Condition	Treatment or Intervention	Phase
recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult giant cell glioblastoma adult gliosarcoma	Drug: thalidomide  Drug: topotecan  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: biological response modifier therapy  Procedure: chemotherapy  Procedure: growth factor antagonist therapy	Phase I

OBJECTIVES:

• Determine tumor response rate, duration of response, time to disease progression, and overall survival of patients with recurrent or refractory malignant glioma treated with topotecan and thalidomide.
• Determine safety and tolerance of this regimen in these patients.

OUTLINE: Patients receive topotecan IV continuously on days 1-21 and oral thalidomide daily on days 1-28. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 2 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed recurrent or progressive supratentorial glioblastoma or anaplastic astrocytoma
• Measurable disease by MRI or CT scan
• No gliomatosis cerebri, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma
• Concurrent registration for the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.) program

PATIENT CHARACTERISTICS: Age:

• Over 18

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 4,000/mm^3
• Platelet count greater than 100,000/mm^3

Hepatic:

• Bilirubin less than 2.0 mg/dL

Renal:

• Creatinine less than 1.6 mg/dL

Other:

• No other concurrent malignancy except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use 2 methods of effective contraception 1 month prior to, during, and for 1 month after study participation

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• No more than 2 prior chemotherapy regimens in adjuvant or metastatic setting
• At least 4 weeks since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• Concurrent anticonvulsants allowed

Illinois
      Rush Cancer Institute at Rush University Medical Center, Chicago,  Illinois,  60612,  United States; Recruiting

Study chairs or principal investigators

Pam Khosla, MD,  Study Chair,  Rush Cancer Institute at Rush University Medical Center   

Study ID Numbers:  CDR0000068544; RUSH-G101; NCI-V01-1651
Record last reviewed:  April 2001
Record first received:  April 10, 2001
ClinicalTrials.gov Identifier:  NCT00014443
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-08