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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003368 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Irinotecan may be effective in treating patients with abnormal liver or kidney function or who have received radiation therapy.
PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating patients with solid tumors or lymphoma who have abnormal liver or kidney function or who have had previous radiation therapy to the pelvis.
Condition | Intervention | Phase |
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Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: irinotecan hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Irinotecan for Patients With Abnormal Liver or Renal Function or With Prior Pelvic Radiation Therapy |
Study Start Date: | June 1998 |
OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan in patients with solid tumors or lymphoma who have liver or renal dysfunction or have had prior pelvic radiation. II. Characterize the pharmacokinetics of irinotecan in these patients.
OUTLINE: This is a dose escalation study. Patients are stratified according to prior pelvic radiation therapy (yes vs no). Patients with no prior pelvic radiation are further stratified according to AST, bilirubin, and creatinine levels. Patients receive irinotecan IV over 90 minutes every 3 weeks for a total of 2 courses. After patients are reevaluated, treatment may continue in the absence of disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients receive escalating doses of irinotecan. Dose escalation proceeds within each stratum until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose below that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 75 patients will be accrued for this study at a rate of 2-3 patients per month.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven solid tumors or lymphoma refractory to standard therapy or for which no standard therapy exists Brain metastases allowed if following criteria met: Asymptomatic Received prior therapy for brain metastases Stable for at least 2 months No concurrent steroid therapy
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALGB 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic and Renal: Albumin at least 2.5 g/dL Prothrombin time less than 1.6 For patients without prior pelvic radiotherapy: AST at least 3 times upper limit of normal (ULN) OR Bilirubin 1.0 - 7.0 mg/dL with any AST OR Creatinine 1.6 - 5.0 mg/dL For patients with prior pelvic radiotherapy: AST less than 3 times ULN AND Bilirubin less than 1.0 mg/dL AND Creatinine less than 1.6 mg/dL Other: Not pregnant or nursing
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors Chemotherapy: At least 4 weeks since prior chemotherapy (at least 6 weeks since melphalan or mitomycin) At least 3 months since suramin No prior nitrosoureas or irinotecan Endocrine therapy: No concurrent steroids (except as antiemetic for chemotherapy) Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since major surgery Other: No concurrent medications known to affect hepatic or renal function (e.g., antiseizure medication or nonsteroidal antiinflammatory drugs)
Study Chair: | Alan P. Venook, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000066357, CLB-9863 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003368 |
Health Authority: | United States: Federal Government |
stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma recurrent adult Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma small intestine lymphoma unspecified adult solid tumor, protocol specific stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma |
stage III adult lymphoblastic lymphoma stage III adult Burkitt lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV adult Burkitt lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma |
Sezary syndrome Lymphoma, Mantle-Cell Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Ileal Diseases Lymphoma, large-cell, immunoblastic Central nervous system lymphoma, primary Duodenal Neoplasms Mycoses Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Anaplastic Hodgkin Disease Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders |
Digestive System Neoplasms Leukemia, B-cell, chronic Camptothecin B-cell lymphomas Leukemia, T-Cell Gastrointestinal Neoplasms Anaplastic large cell lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous Hodgkin's disease Gastrointestinal Diseases Cutaneous T-cell lymphoma Irinotecan Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Jejunal Diseases Therapeutic Uses Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |