NCT00008424CompletedPhase 1
A Phase I Study of Irinotecan in Patients With Refractory Solid Tumors Who Are Concomitantly Receiving Anticonvulsants
Children's Oncology Group51 sites in 3 countries7 target enrollmentStarted: October 1, 2000Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Children's Oncology Group
- Enrollment
- 7
- Locations
- 51
- Primary Endpoint
- Maximum tolerable dose (MTD) of irinotecan
Study Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating children with refractory or advanced solid tumors who are receiving anticonvulsants.
Detailed Description
OBJECTIVES:
- Determine the maximum tolerated dose of irinotecan in children with refractory or advanced solid tumors receiving anticonvulsants.
- Determine the dose-limiting toxicity of irinotecan in this patient population.
- Evaluate the pharmacokinetic behavior of this treatment regimen in these patients.
- Determine, preliminarily, the antitumor activity of this treatment regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to type of concurrent anticonvulsant (enzyme activating anticonvulsants vs valproic acid vs other anticonvulsants).
Patients receive irinotecan IV over 1 hour daily for 5 days. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan 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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 1 Year to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed malignancy refractory to conventional therapy or for which no conventional therapy exists
- •Histologic confirmation not required for brain stem tumors
- •Concurrently on anticonvulsants at a steady level for at least 2 weeks
- •PATIENT CHARACTERISTICS:
- •1-21 years old
- •Performance status:
- •Karnofsky 50-100% (over 10 years of age)
- •Lansky 50-100% (10 years of age or under)
- •Life expectancy:
- •At least 8 weeks
- •Hematopoietic:
- •Neutrophil count at least 1,000/mm3
- •Platelet count at least 100,000/mm3 (transfusion independent)
- •Hemoglobin at least 8.0 g/dL (red blood cell transfusions allowed)
- •Bilirubin no greater than 1.5 times normal for age
- •SGPT less than 5 times normal for age
- •Albumin at least 2 g/dL
- •Creatinine no greater than 1.5 times normal for age OR
- •Creatinine clearance or radioisotope glomerular filtration rate at least lower limit of normal for age
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No uncontrolled infection
- •No evidence of active graft-vs-host disease
- •Neurologic deficits for CNS tumors stable for at least 2 weeks prior to study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 1 week since prior antineoplastic biologic therapy
- •At least 6 months since prior allogeneic stem cell transplantation
- •At least 1 week since prior growth factors
- •No concurrent sargramostim (GM-CSF)
- •No concurrent prophylactic growth factors during first course of study therapy
- •Recovered from prior immunotherapy
- •Chemotherapy:
- •At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosourea) and recovered
- •Endocrine therapy:
- •Concurrent dexamethasone for CNS tumors with increased intracranial pressure allowed if dose stable or decreasing for at least 2 weeks prior to study
- •Radiotherapy:
- •At least 2 weeks since prior local palliative radiotherapy (small part)
- •At least 6 months since prior craniospinal radiotherapy
- •At least 6 months since prior radiotherapy to at least 50% of pelvis
- •At least 6 weeks since prior substantial bone marrow radiotherapy
- •Recovered from prior radiotherapy
- •Not specified
- •No other concurrent investigational agent
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Maximum tolerable dose (MTD) of irinotecan
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (51)
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