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|
|Study Completion Date :||May 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|