Overview

Topotecan and Thalidomide in Treating Patients With Recurrent or Refractory Malignant Glioma

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Rush University Medical Center
Treatments:
Thalidomide
Topotecan
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