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

Sponsor

Rush University Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00014443

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Drug: thalidomide Drug: topotecan hydrochloride	Phase 1

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Primary Purpose:

Treatment

Official Title:

A Pilot Study Of Hycamtin (Topotecan) And Thalomid (Thalidomide) In Patients With Recurrent Malignant Gliomas

Study Start Date :

Aug 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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