Unspecified Childhood Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified childhood solid tumor, protocol specific
Brief summary
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.
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.
Interventions
DRUGirinotecan hydrochloride
DRUGvincristine sulfate
Sponsors
National Cancer Institute (NCI)
Children's Oncology Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | Length of study |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity | — |
Countries
Australia, United States
Outcome results
None listed