A Pilot Study Of Hycamtin (Topotecan) And Thalomid (Thalidomide) In Patients With Recurrent Malignant Gliomas
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
A Pilot Study Of Hycamtin (Topotecan) And Thalomid (Thalidomide) In Patients With Recurrent Malignant Gliomas
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Pam G. Khosla, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Rush University Medical Center
Authority:
United States: Federal Government
Study ID:
CDR0000068544
NCT ID:
NCT00014443
Start Date:
August 2000
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- recurrent adult brain tumor
- adult glioblastoma
- adult anaplastic astrocytoma
- adult giant cell glioblastoma
- adult gliosarcoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Glioma
Name | Location |
|---|---|
| Rush Cancer Institute at Rush University Medical Center | Chicago, Illinois 60612 |
