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Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors Clinical research trials and Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors. Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors clinical trial. Test subjects typically receive the most expert healthcare available for their Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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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. Irinotecan and Cisplatin With or Without Amifostine in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
2. Fenretinide in Treating Children With Solid Tumors
3. Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors
4. Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma
5. Irofulven in Treating Children With Recurrent or Refractory Solid Tumors
Related Studies:
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Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors
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