Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: irinotecan hydrochloride |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Irinotecan in Patients With Refractory Solid Tumors Who Are Concomitantly Receiving Anticonvulsants |
| Study Start Date: | October 2000 |
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.
Patients are followed every 6 months for up to 4 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 3-25 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 1 Year to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Age:
- 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)
Hepatic:
- Bilirubin no greater than 1.5 times normal for age
- SGPT less than 5 times normal for age
- Albumin at least 2 g/dL
Renal:
- 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
Other:
- 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
Surgery:
- Not specified
Other:
- No other concurrent investigational agent
Contacts and Locations
Show 51 Study Locations| Study Chair: | Albert Moghrabi, MD | Hopital Sainte Justine |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00008424 History of Changes |
| Other Study ID Numbers: | CDR0000068410, COG-P9871, POG-P9871 |
| Study First Received: | January 6, 2001 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
unspecified childhood solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasms Anticonvulsants Irinotecan Camptothecin Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Phytogenic |
Antineoplastic Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013