Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00008424 |
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 I |
Study Type: | Interventional |
Study Design: | 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:
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.
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
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Albert Moghrabi, MD | Hopital Sainte Justine |
Study ID Numbers: | CDR0000068410, COG-P9871, POG-P9871 |
Study First Received: | January 6, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00008424 |
Health Authority: | United States: Federal Government |
unspecified childhood solid tumor, protocol specific |
Irinotecan Camptothecin |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |