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Home > "C" Clinical Trials Conditions > Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors  Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors
Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors
For Condition: unspecified childhood solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb , 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 combining carboplatin and irinotecan in treating children who have refractory solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose and recommended phase II dose of carboplatin and irinotecan in children with refractory solid tumors. - Determine the safety profile and dose-limiting toxic effects of this regimen in these patients. - Determine the pharmacokinetics of this regimen in these patients. - Determine the preliminary anti-tumor activity of this regimen in these patients. OUTLINE: This is a dose-escalation study of carboplatin and irinotecan. Patients receive carboplatin IV over 50 minutes on day 1 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan 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. Patients are followed for at least 30 days. PROJECTED ACCRUAL: A total of 25-30 patients will be accrued for this study within 6-9 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed solid tumor, including primary brain tumor - Progressive disease on standard therapy or for which no standard therapy exists - No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: - 1 to 21 Performance status: - Lansky 50-100% (age 10 and under) - Karnofsky 50-100% (over age 10) Life expectancy: - At least 8 weeks Hematopoietic: - Absolute neutrophil count greater than 1,000/mm3 - Platelet count greater than 100,000/mm3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - ALT no greater than 2.5 times upper limit of normal Renal: - Glomerular filtration rate at least 30 mL/min Other: - No active infection - No serious uncontrolled medical disorder - No psychiatric disorder or other disorder that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 6 months since prior allogeneic bone marrow transplantation without evidence of acute or chronic graft versus host disease - At least 3 months since prior autologous bone marrow or peripheral blood stem cell transplantation - At least 4 weeks since prior immunotherapy and recovered - No concurrent immunotherapy Chemotherapy: - No more than 3 prior chemotherapy regimens - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - No other concurrent chemotherapy Endocrine therapy: - Concurrent hormone replacement therapy or oral contraceptives allowed - No other concurrent hormonal therapy Radiotherapy: - At least 4 weeks since prior radiotherapy (including for brain metastases) and recovered - No concurrent radiotherapy Surgery: - Not specified Other: - No other concurrent investigational anticancer drugs - No other concurrent antitumor therapy - No concurrent anticonvulsants (e.g., phenytoin, phenobarbital, or carbamazepine) except gabapentin (Neurontin)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AshwinGollerkeri, Study Chair, Bristol-Myers Squibb
Washington University Medical Center
St. Louis, Missouri, 63105
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Canada
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2916
United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
United States
Additional Information:
Study ID Numbers: CDR0000068908; CNMC-2782,SJCRH-CARCPT,BMS-CA124-001,NCI-G01-2016,MSKCC-01071
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00024284
Other Unspecified Childhood Solid Tumor, Protocol Specific Studies:
1. Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors
2. Fenretinide in Treating Children With Solid Tumors
3. Bortezomib in Treating Children With Advanced Solid Tumors
4. Oxaliplatin in Treating Children With Advanced Solid Tumors
5. Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma
Related Studies:
Other unspecified childhood solid tumor, protocol specific Clinical Trials
Other District of Columbia Clinical Trials
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Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors
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