Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

OBJECTIVES: - 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.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed advanced malignancy - No active brain metastases (as indicated by clinical symptoms, cerebral edema, or progressive tumor growth) that have been unstable for at least 8 weeks PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastases are present) Renal - Creatinine no greater than 1.5 times ULN - No history of hemorrhagic cystitis - No history of microscopic hematuria associated with drug therapy or radiotherapy or of unknown origin Cardiovascular - No significant cardiac disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Able to comply with study schedule and assessments - No other significant nonmalignant systemic disease - No active infection - No other condition that would in the investigator's opinion make the patient an inappropriate study candidate PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No more than 3 prior chemotherapy regimens - More than 4 weeks since prior chemotherapy Endocrine therapy - Not specified Radiotherapy - More than 4 weeks since prior definitive radiotherapy (except for palliative reasons to sites of nonmeasurable disease, in patients with measurable disease at baseline) - Concurrent palliative radiotherapy allowed Surgery - More than 4 weeks since prior major thoracic or abdominal surgery Other - Recovered from prior therapy (except alopecia or stable grade 1 neuropathy) - More than 4 weeks since prior investigational agents - No prior myeloablative therapy


NCT ID:

NCT00059917


Primary Contact:

Study Chair
Jakob Dupont, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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