Expired Study
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San Francisco, California 94143


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating children with refractory or advanced solid tumors who are receiving anticonvulsants.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose of irinotecan in children with refractory or advanced solid tumors receiving anticonvulsants. - Determine the dose-limiting toxicity of irinotecan in this patient population. - Evaluate the pharmacokinetic behavior of this treatment regimen in these patients. - Determine, preliminarily, the antitumor activity of this treatment regimen in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to type of concurrent anticonvulsant (enzyme activating anticonvulsants vs valproic acid vs other anticonvulsants). Patients receive irinotecan IV over 1 hour daily for 5 days. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 6 months for up to 4 years and then annually thereafter. PROJECTED ACCRUAL: A total of 3-25 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed malignancy refractory to conventional therapy or for which no conventional therapy exists - Histologic confirmation not required for brain stem tumors - Concurrently on anticonvulsants at a steady level for at least 2 weeks PATIENT CHARACTERISTICS: Age: - 1-21 years old Performance status: - Karnofsky 50-100% (over 10 years of age) - Lansky 50-100% (10 years of age or under) Life expectancy: - At least 8 weeks Hematopoietic: - Neutrophil count at least 1,000/mm3 - Platelet count at least 100,000/mm3 (transfusion independent) - Hemoglobin at least 8.0 g/dL (red blood cell transfusions allowed) Hepatic: - Bilirubin no greater than 1.5 times normal for age - SGPT less than 5 times normal for age - Albumin at least 2 g/dL Renal: - Creatinine no greater than 1.5 times normal for age OR - Creatinine clearance or radioisotope glomerular filtration rate at least lower limit of normal for age Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No uncontrolled infection - No evidence of active graft-vs-host disease - Neurologic deficits for CNS tumors stable for at least 2 weeks prior to study PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 1 week since prior antineoplastic biologic therapy - At least 6 months since prior allogeneic stem cell transplantation - At least 1 week since prior growth factors - No concurrent sargramostim (GM-CSF) - No concurrent prophylactic growth factors during first course of study therapy - Recovered from prior immunotherapy Chemotherapy: - At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosourea) and recovered Endocrine therapy: - Concurrent dexamethasone for CNS tumors with increased intracranial pressure allowed if dose stable or decreasing for at least 2 weeks prior to study Radiotherapy: - At least 2 weeks since prior local palliative radiotherapy (small part) - At least 6 months since prior craniospinal radiotherapy - At least 6 months since prior radiotherapy to at least 50% of pelvis - At least 6 weeks since prior substantial bone marrow radiotherapy - Recovered from prior radiotherapy Surgery: - Not specified Other: - No other concurrent investigational agent


NCT ID:

NCT00008424


Primary Contact:

Study Chair
Albert Moghrabi, MD
Hopital Sainte Justine


Backup Contact:

N/A


Location Contact:

San Francisco, California 94143
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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