Polyglutamate Camptothecin in Treating Patients With Advanced Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase I Study of CT-2106 in Patients With Advanced Malignancy

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: polyglutamate camptothecin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: polyglutamate camptothecin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific