Topotecan and Thalidomide in Treating Patients With Recurrent or Refractory Malignant Glioma (NCT00014443) | Clinical Trial Compass
TerminatedPhase 2
Topotecan and Thalidomide in Treating Patients With Recurrent or Refractory Malignant Glioma
Stopped: Poor enrollment
United States5 participantsStarted 2000-08
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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