Expired Study
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Memphis, Tennessee 38105


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 oxaliplatin in treating children who have advanced solid tumors.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose of oxaliplatin in children with advanced solid tumors. - Determine the toxic effects of this drug in these patients. - Determine the safety of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. - Assess the relationship between pharmacokinetic parameters and toxicity of this regimen and response in these patients. - Determine the anti-tumor effects of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive oxaliplatin IV over 2 hours on day 1 (every 3 weeks for up to 6 courses) OR on days 1, 14, and 28 (every 6 weeks for up to 3 courses). Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated dose (MTD) is determined. 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. Once the MTD for dose levels 1-4 is determined, an additional cohort of 3-6 patients is accrued and treated with oxaliplatin as above every 2 weeks (for up to 9 doses). PROJECTED ACCRUAL: Approximately 6-20 patients will be accrued for this study within 1-3.3 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed metastatic or unresectable solid tumors that are not amenable to standard treatment - Histological confirmation not required for brain stem tumors - No known brain metastases - No leukemia PATIENT CHARACTERISTICS: Age: - 21 and under Performance status: - ECOG 0-2 OR - Lansky 50-100% Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,000/mm^3 (except with marrow involvement) - Hemoglobin at least 8 g/dL - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin 0.2-1.4 mg/dL - AST/ALT no greater than 3 times upper limit of normal Renal: - Creatinine normal for age OR - Creatinine clearance at least 50 mL/min - Electrolytes, calcium, and phosphorus normal Cardiovascular: - No symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia Other: - Not pregnant or nursing - Fertile patients must use effective contraception - HIV negative - No active graft-vs-host disease (GVHD) - No allergy to platinum compounds or antiemetics - No uncontrolled concurrent illness or infection - No evidence of neuropathy - Blood sugar normal PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 1 week since prior hematopoietic growth factors - At least 3 months since prior stem cell transplantation and recovered Chemotherapy: - At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea) Endocrine therapy: - Not specified Radiotherapy: - At least 6 weeks since prior extensive radiotherapy to significant marrow-containing compartment - At least 6 months since prior craniospinal radiotherapy; total abdominal, pelvic, or extensive lung radiotherapy; or mantle and Y-port radiotherapy - At least 6 months since prior total body irradiation Surgery: - Not specified Other: - No concurrent therapy for GVHD - No other concurrent anticancer investigational or commercial agents - No other concurrent anticancer therapy


NCT ID:

NCT00005844


Primary Contact:

Study Chair
Sheri L. Spunt, MD
St. Jude Children's Research Hospital


Backup Contact:

N/A


Location Contact:

Memphis, Tennessee 38105
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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