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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00008424
Recruitment Status : Completed
First Posted : June 5, 2003
Last Update Posted : May 5, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

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 or disease Intervention/treatment Phase
Unspecified Childhood Solid Tumor, Protocol Specific Drug: irinotecan hydrochloride Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Primary Purpose: 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
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Maximum tolerable dose (MTD) of irinotecan


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00008424


Locations
Show Show 51 study locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Albert Moghrabi, MD Hopital Sainte Justine
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00008424    
Other Study ID Numbers: P9871
COG-P9871 ( Other Identifier: Children's Oncology Group )
POG-P9871 ( Other Identifier: Pediatric Oncology Group )
CDR0000068410 ( Other Identifier: Clinicaltrials.gov )
First Posted: June 5, 2003    Key Record Dates
Last Update Posted: May 5, 2014
Last Verified: May 2014
Keywords provided by Children's Oncology Group:
unspecified childhood solid tumor, protocol specific
Additional relevant MeSH terms:
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Neoplasms
Irinotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents