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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00008424
First received: January 6, 2001
Last updated: July 23, 2008
Last verified: March 2002
  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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2000
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.

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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00008424

  Hide Study Locations
Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000
University of California San Diego Cancer Center
La Jolla, California, United States, 92093-0658
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Children's Hospital of Orange County
Orange, California, United States, 92868
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States, 94304
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
United States, Colorado
Children's Hospital of Denver
Denver, Colorado, United States, 80218
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Florida
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, United States, 32610-100277
United States, Georgia
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
United States, Illinois
Children's Memorial Hospital, Chicago
Chicago, Illinois, United States, 60614
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Boston Floating Hospital Infants and Children
Boston, Massachusetts, United States, 02111
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109-7821
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Cardinal Glennon Children's Hospital
Saint Louis, Missouri, United States, 63104
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Columbia Presbyterian Hospital
New York, New York, United States, 10032
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Ohio
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45229-3039
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
United States, Tennessee
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States, 76104
Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
United States, Wisconsin
CCOP - Green Bay
Green Bay, Wisconsin, United States, 54301
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792-0001
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
Australia, South Australia
Women's and Children's Hospital
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3
Sponsors and Collaborators
Children's Oncology Group
Investigators
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 23, 2013