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Home > "O" Clinical Trials Conditions > Oxaliplatin in Treating Children With Advanced Solid Tumors  Oxaliplatin in Treating Children With Advanced Solid Tumors
Oxaliplatin in Treating Children With Advanced Solid Tumors
For Condition: unspecified childhood solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): St. Jude Children's Research Hospital , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SheriSpunt, Study Chair, St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
United States
Additional Information:
Study ID Numbers: CDR0000067860; NCI-T99-0059,SJCRH-OXAL1
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005844
Other Unspecified Childhood Solid Tumor, Protocol Specific Studies:
1. Irofulven in Treating Children With Recurrent or Refractory Solid Tumors
2. 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia
3. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors
4. Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors
5. Oxaliplatin in Treating Children With Advanced Solid Tumors
Related Studies:
Other unspecified childhood solid tumor, protocol specific Clinical Trials
Other Tennessee Clinical Trials
Other Memphis Clinical Trials
Oxaliplatin in Treating Children With Advanced Solid Tumors
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