Status:
COMPLETED
A Phase I Trial Using Combination Irinotecan and Thalidomide for Recurrent CNS Tumors
Lead Sponsor:
University of New Mexico
Conditions:
Brain and Nervous System
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The study will try to answer these questions: 1. What is the highest dose of thalidomide brain cancer patients can receive safely in combination with irinotecan? 2. How well does this combination wor...
Detailed Description
This is a Phase I study, which means these trials are generally comparatively small and are used to determine toxicity and maximum dose. Currently, there are no "standard" treatments for Recurrent CNS...
Eligibility Criteria
Inclusion
- Biopsy proven high grade astrocytomas, glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma, mixed oligodendroglioma.
- Subjects are allowed to have definitive surgery and/or radiation treatment to their tumors.
- Subjects are allowed to have previous chemotherapy for their tumors.
- Subjects who previous diagnosed to have a low grade lesion need a second biopsy to show transformation into a high grade histology.
- Subjects need to have radiographic or biopsy proven recurrent disease.
- ECORT performance status 2 or lower. See appendix I.
- Baseline laboratory values within 30 days of study entry: hemoglobin 10 gm/dl; absolute neutrophil count 1,500 cells/ml; platelet counts 100,000 cells/ml; SGOT/AST, SGPT/ALT, alkaline phosphatase, LDH 3high normal limit; total bilirubin 2.0 mg/dl.
- Ability to provide written informed consent.
- Age \> 18 years.
- Female patients of childbearing potential must have a documented negative serum pregnancy test within 14 days of study entry.
- All subjects must agree to use an effective method of contraception for the duration of treatment if engaged in sexual activity where conception is possible, as specified in the STEP program for thalidomide.
Exclusion
- Therapy with any investigational drug (other than drugs available on treatment IND and used for FDA-sanctioned indications) and/or any chemotherapy regimen within 28 days of study entry.
- Prior therapy with either irinotecan or thalidomide.
- Oxygen saturation 90% on room air.
- Cardiac insufficiency at New York Heart Association status 2 or greater.
- Other active malignancies except basal or squamous cell carcinoma of the skin or in situ cervical and breast lesions.
- History of neuropsychiatric disorder or altered mental status which prevent informed consent or compliance with protocol requirement.
- Known hypersensitivity or allergic reaction to study drug.
- Women at any stage of pregnancy.
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00251797
Start Date
March 1 2000
End Date
June 1 2006
Last Update
January 7 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of New Mexico
Albuquerque, New Mexico, United States, 87131