Combination Chemotherapy in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
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|ClinicalTrials.gov Identifier: NCT00006095|
Recruitment Status : Completed
First Posted : May 22, 2003
Last Update Posted : February 21, 2014
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vincristine plus irinotecan in treating children who have solid tumors that have not responded to previous therapy.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Childhood Solid Tumor, Protocol Specific||Drug: irinotecan hydrochloride Drug: vincristine sulfate||Phase 1|
- Determine the maximum tolerated dose and dose limiting toxicity of vincristine when administered in combination with irinotecan in children with refractory solid tumors.
- Determine the safe and tolerable phase II dose of this combination regimen in this patient population.
- Determine the pharmacokinetics of this combination regimen in these patients.
- Determine the incidence and severity of other toxicities of this combination regimen in these patients.
- Determine preliminary evidence of antitumor activity of this combination regimen in this patient population.
OUTLINE: This is a dose-escalation study of vincristine.
Patients receive vincristine IV on day 2 of the first course (day 1 of subsequent courses) and days 8, 15, 22, and 29, and irinotecan IV over 1 hour on days 1-5 and 22-26. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease receive additional courses of therapy for a maximum of 1 year.
Cohorts of 3-6 patients receive escalating doses of vincristine 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 4 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 3-12 patients will be accrued for this study within 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Trial of Irinotecan (NSC# 616348) Plus Vincristine in Children With Solid Tumors|
|Study Start Date :||July 2000|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||September 2005|
|Experimental: Vincristine Sulfate 1.5 mg/m2/wk and Irinotecan||
Drug: irinotecan hydrochloride
Drug: vincristine sulfate
|Experimental: Vincristine sulfate 2.0 mg/m2/wk and Irinotecan||
Drug: irinotecan hydrochloride
Drug: vincristine sulfate
- Progression Free Survival [ Time Frame: Length of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006095
|United States, California|
|Cancer Center and Beckman Research Institute, City of Hope|
|Duarte, California, United States, 91010-3000|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027-0700|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|Children's Hospital of Orange County|
|Orange, California, United States, 92868|
|UCSF Cancer Center and Cancer Research Institute|
|San Francisco, California, United States, 94143-0128|
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010-2970|
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-5289|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0752|
|United States, Minnesota|
|University of Minnesota Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|United States, New York|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|United States, Ohio|
|Children's Hospital Medical Center - Cincinnati|
|Cincinnati, Ohio, United States, 45229-3039|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Children's Hospital of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|United States, Washington|
|Children's Hospital and Regional Medical Center - Seattle|
|Seattle, Washington, United States, 98105|
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792-6164|
|Australia, Western Australia|
|Princess Margaret Hospital for Children|
|Perth, Western Australia, Australia, 6001|
|Study Chair:||Cynthia S. Kretschmar, MD||Floating Hospital for Children at Tufts - New England Medical Center|