A Phase 1 interventional study of polyglutamate camptothecin in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-30.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
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.
Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
This study is completed, as verified in Apr 2005. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center