A Trial of Irinotecan (NSC# 616348) Plus Vincristine in Children With Solid Tumors
1 Year
21 Years
Both
Unspecified Childhood Solid Tumor, Protocol Specific
Trial Information
A Trial of Irinotecan (NSC# 616348) Plus Vincristine in Children With Solid Tumors
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Cynthia S. Kretschmar, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Floating Hospital for Children at Tufts - New England Medical Center
Authority:
United States: Federal Government
Study ID:
CDR0000068102
NCT ID:
NCT00006095
Start Date:
July 2000
Completion Date:
Related Keywords:
- Unspecified Childhood Solid Tumor, Protocol Specific
- unspecified childhood solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
| Mount Sinai School of Medicine | New York, New York 10029 |
| UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
| University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
| Cancer Center and Beckman Research Institute, City of Hope | Duarte, California 91010-3000 |
| Children's Hospital Los Angeles | Los Angeles, California 90027-0700 |
| Children's Hospital of Orange County | Orange, California 92668 |
| Children's National Medical Center | Washington, District of Columbia 20010-2970 |
| Children's Mercy Hospital | Kansas City, Missouri 64108 |
| Children's Hospital Medical Center - Cincinnati | Cincinnati, Ohio 45229-3039 |
| Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
| Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
