Polyglutamate Camptothecin in Treating Patients With Advanced Cancer
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|ClinicalTrials.gov Identifier: NCT00059917|
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : May 30, 2013
RATIONALE: Drugs used in chemotherapy such as polyglutamate camptothecin may be able to deliver the drug directly to tumor cells while leaving normal cells undamaged.
PURPOSE: Phase I trial to study the effectiveness of polyglutamate camptothecin in treating patients who have advanced cancer.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: polyglutamate camptothecin||Phase 1|
- Determine the maximum tolerated dose of polyglutamate camptothecin (CT-2106) in patients with advanced malignancies.
- Determine the tolerability of this drug in these patients.
- Determine the safety of this drug in these patients.
- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
- Determine the disease response in patients treated with this drug.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive polyglutamate camptothecin (CT-2106) IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond confirmation of complete response.
Cohorts of 3-6 patients receive escalating doses of CT-2106 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 3 weeks.
PROJECTED ACCRUAL: A total of 12-48 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Study of CT-2106 in Patients With Advanced Malignancy|
|Study Start Date :||January 2003|
|Actual Study Completion Date :||May 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00059917
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Jakob Dupont, MD||Memorial Sloan Kettering Cancer Center|