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

  Show 51 Study Locations
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 22, 2013