Combination Chemotherapy in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
NCT ID: NCT00006095
Last Updated: 2014-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2000-07-31
2005-09-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vincristine Sulfate 1.5 mg/m2/wk and Irinotecan
irinotecan hydrochloride
vincristine sulfate
Vincristine sulfate 2.0 mg/m2/wk and Irinotecan
irinotecan hydrochloride
vincristine sulfate
Interventions
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irinotecan hydrochloride
vincristine sulfate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed initial diagnosis of malignant solid tumor refractory to conventional therapy or for which no effective therapy exists
* Brain tumors allowed if not on anticonvulsants
* Brainstem gliomas allowed without histologic diagnosis
* Solid lymphomas allowed
* No bone marrow involvement
PATIENT CHARACTERISTICS:
Age:
* 1 to 21
Performance status:
* Karnofsky 50-100% if over 10 years of age
* Lansky 50-100% if 10 years of age and under
Life expectancy:
* At least 8 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 8 g/dL (transfusion allowed)
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* ALT less than 5 times normal
* Albumin at least 2 g/dL
Renal:
* Creatinine normal for age OR
* Glomerular filtration rate normal for age
Other:
* No uncontrolled infection
* No other significant systemic illness
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 1 week since prior biologic therapy and recovered
* At least 1 week since prior growth factors
* No prior stem cell transplantation
Chemotherapy:
* At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
* No more than 2 prior chemotherapy regimens
* No other concurrent cancer chemotherapy
Endocrine therapy:
* Concurrent dexamethasone allowed in patients with CNS tumors provided dose is stable or decreasing for at least 2 weeks prior to study
Radiotherapy:
* Recovered from prior radiotherapy
* At least 2 weeks since prior local palliative radiotherapy (small port)
* No prior substantial bone marrow radiotherapy
* No prior central axis radiotherapy
* No concurrent radiotherapy
Surgery:
* Not specified
Other:
* No concurrent anticonvulsants
* No other concurrent anticancer therapy or investigational agents
1 Year
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Cynthia S. Kretschmar, MD
Role: STUDY_CHAIR
Floating Hospital for Children at Tufts - New England Medical Center
Locations
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Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Countries
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Other Identifiers
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COG-P9971
Identifier Type: OTHER
Identifier Source: secondary_id
CCG-P9971
Identifier Type: OTHER
Identifier Source: secondary_id
POG-9971
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000068102
Identifier Type: OTHER
Identifier Source: secondary_id
P9971
Identifier Type: -
Identifier Source: org_study_id
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