Expired Study
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Bethesda, Maryland 20892


Purpose:

This study examines a 96 hour infusion schedule of irinotecan alternating with 72 hour drug-free intervals in patients with solid tumors in order to determine the maximum tolerated dose of this regimen.


Study summary:

Irinotecan (CPT-11) is a promising camptothecin analogue with activity in solid tumors. In Phase I studies using short intravenous infusion schedules, the predominant drug toxicities have been gastrointestinal, such as diarrhea, and myelosuppression. In animal studies, prolonged infusion schedules followed by short drug-free intervals have resulted in preservation of antitumor activity and decreased drug toxicity. Therefore, we propose to examine a 96 hour infusion schedule of irinotecan alternating with 72 hour drug-free intervals in patients with solid tumors in order to determine the maximum tolerated dose of this regimen. The duration of these treatments will be escalated in our Phase I study until patients are receiving therapy for 2 out of every 3 weeks. Standard Phase I drug toxicity and tumor response information will be monitored and the pharmacokinetics of irinotecan and its active metabolite, SN-38 will also be examined. We will also attempt to monitor the intracellular molecular effects of SN-38 therapy in blood, bone marrow, and, whenever possible, tumor tissue.


Criteria:

DISEASE CHARACTERISTICS: Recurrent or metastatic cancer, including lymphoma. No leukemia. No active CNS disease. Refractory to all effective therapy OR No effective therapy exists. Measurable disease not required. PRIOR/CONCURRENT THERAPY: Biologic Therapy: Greater than 4 weeks and recovered from immunotherapy. Chemotherapy: Greater than 4 weeks and recovered from chemotherapy. Previous therapy with irinotecan is permitted. Endocrine Therapy: Not specified. Radiotherapy: Greater than 4 weeks since radiotherapy. Surgery: Recovered from prior surgery. PATIENT CHARACTERISTICS: Age: 18 and over. Performance status: ECOG 0-2. Hematopoietic: AGC greater than 1,500. Platelets greater than 100,000. Hepatic: Bilirubin no greater than 1.5 mg/dL. AST no greater than 2 times normal. Renal: Creatinine no greater than 1.5 mg/dL. OTHER: HIV negative. No active infection requiring antibiotics. No concurrent medical illness that would interfere with chemotherapy. No pregnant or nursing women. Adequate contraception required of fertile patients. Imaging/exams for tumor measurement within 28 days prior to registration.


NCT ID:

NCT00001495


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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