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

Phase 2TerminatedNCT00014443

Rush University Medical Center5 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Brain and Central Nervous System Tumors

Interventions

thalidomideDRUG

topotecan hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Rush Cancer Institute at Rush University Medical Center

Chicago, Illinois, United States

Data from ClinicalTrials.gov

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