Los Angeles, California 90095

  • Unspecified Childhood Solid Tumor, Protocol Specific

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.


Study summary:

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.


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: 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


Study is Available At:


Original ID:

P9871


NCT ID:

NCT00008424


Secondary ID:

COG-P9871


Study Acronym:


Brief Title:

Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants


Official Title:

A Phase I Study of Irinotecan in Patients With Refractory Solid Tumors Who Are Concomitantly Receiving Anticonvulsants


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

1 Year


Maximum Age:

21 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Children's Oncology Group


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

7


Enrollment Type:

Actual


Overall Contact Information

Official Name:Albert Moghrabi, MD
Study Chair
Hopital Sainte Justine

Study Dates

Start Date:October 2000
Completion Date:September 2006
Completion Type:Actual
Primary Completion Date:September 2005
Primary Completion Type:Actual
Verification Date:May 2014
Last Changed Date:May 2, 2014
First Received Date:January 6, 2001

Study Outcomes

Outcome Type:Primary Outcome
Measure:Maximum tolerable dose (MTD) of irinotecan
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:irinotecan hydrochloride

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Children's Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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