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Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants
This study has been completed.
First Received: January 6, 2001   Last Updated: July 23, 2008   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00008424
  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 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

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

Study ID Numbers: CDR0000068410, COG-P9871, POG-P9871
Study First Received: January 6, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00008424     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Irinotecan
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Central Nervous System Agents
Pharmacologic Actions
Camptothecin
Anticonvulsants

ClinicalTrials.gov processed this record on November 09, 2009