- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006095
Combination Chemotherapy in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
A Trial of Irinotecan (NSC# 616348) Plus Vincristine in Children With Solid Tumors
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
- 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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Western Australia
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Perth, Western Australia, Australia, 6001
- Princess Margaret Hospital for Children
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California
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Duarte, California, United States, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, United States, 90027-0700
- Children's Hospital Los Angeles
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Orange, California, United States, 92868
- Children's Hospital of Orange County
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San Francisco, California, United States, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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District of Columbia
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Washington, District of Columbia, United States, 20010-2970
- Children's National Medical Center
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Indiana
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Indianapolis, Indiana, United States, 46202-5289
- Indiana University Cancer Center
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Michigan
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Ann Arbor, Michigan, United States, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Cancer Center
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Missouri
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Kansas City, Missouri, United States, 64108
- Children's Mercy Hospital
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New York
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, United States, 10016
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
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New York, New York, United States, 10029
- Mount Sinai School of Medicine
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Ohio
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Cincinnati, Ohio, United States, 45229-3039
- Children's Hospital Medical Center - Cincinnati
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, United States, 15213
- Children's Hospital of Pittsburgh
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Tennessee
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Nashville, Tennessee, United States, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Houston, Texas, United States, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Washington
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Seattle, Washington, United States, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Wisconsin
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Madison, Wisconsin, United States, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Vincristine Sulfate 1.5 mg/m2/wk and Irinotecan
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Other Names:
Other Names:
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EXPERIMENTAL: Vincristine sulfate 2.0 mg/m2/wk and Irinotecan
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Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression Free Survival
Time Frame: Length of study
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Length of study
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Secondary Outcome Measures
Outcome Measure |
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Toxicity
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P9971
- COG-P9971 (OTHER: Children's Oncology Group)
- CCG-P9971 (OTHER: Children's Cancer Group)
- POG-9971 (OTHER: Pediatric Oncology Group)
- CDR0000068102 (OTHER: Clinical Trials.gov)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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