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Home > "P" Clinical Trials Conditions > Polyglutamate Camptothecin in Treating Patients With Advanced Cancer  Polyglutamate Camptothecin in Treating Patients With Advanced Cancer
Polyglutamate Camptothecin in Treating Patients With Advanced Cancer
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JakobDupont, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting David Spriggs 212-639-5332
Additional Information:
Study ID Numbers: CDR0000298987; MSKCC-03002,CTI-PGC101
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059917
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors
2. Chemotherapy in Treating Patients With Advanced Solid Tumors
3. AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors
4. Buspirone in Reducing Shortness of Breath in Patients With Cancer
5. DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
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Polyglutamate Camptothecin in Treating Patients With Advanced Cancer
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