Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Trial Contact Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Active Over 18 Other RUSH-G101 NCI-V01-1651

Objectives

1. 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.
2. Determine safety and tolerance of this regimen in these patients.

Entry 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

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

Patient Characteristics:

Age:

• Over 18

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 4,000/mm³
• Platelet count greater than 100,000/mm³

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

Projected Accrual

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

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.

Disclaimer

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Trial Contact Information

Trial Lead Organizations

Rush Cancer Institute at Rush University Medical Center

Pam Khosla, MD, Protocol chair		Ph: 312-942-5904

U.S.A.
Illinois
	Chicago
	Rush Cancer Institute at Rush University Medical Center
		Pam Khosla, MD	Ph:  312-942-5904
		Philip Bonomi, MD	Ph:  312-942-5904
			Email: Philip_Bonomi@rsh.net

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