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Clinical Trials/NCT00070473
NCT00070473CompletedPhase 1

A Phase I Study of Pemetrexed (LY231514, Alimta) in Children and Adolescents With Recurrent Solid Tumors

Children's Oncology Group20 sites in 2 countries33 target enrollmentStarted: October 1, 2003Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
33
Locations
20
Primary Endpoint
Event Free Survival
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, use different ways to stop tumor cells from dividing so they stop growing or die. Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed disodium in treating young patients with recurrent solid tumors.

Detailed Description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of pemetrexed disodium in children and adolescents with refractory solid tumors.
  • Determine the dose-limiting toxic effects of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.

Secondary

  • Determine, preliminarily, the antitumor activity of this drug in these patients.
  • Correlate the presence of the C677T polymorphism of the methylenetetrahydrolate reductase gene, the presence of a polymorphism in the enhancer region of the thymidylate synthase (TS) gene promoter (2R and 3R tandem repeats), the presence of a polymorphism within one of those repeats, and the presence of a functional polymorphism in the 3'-untranslated region with toxicity in patients treated with this drug.
  • Correlate homocysteine and methylmalonic acid levels at study entry with toxicity in patients treated with this drug.
  • Correlate various gene expression profiles with response in patients treated with this drug.

Study Design

Study Type
Interventional
Primary Purpose
Treatment

Eligibility Criteria

Ages
1 Year to 21 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •DISEASE CHARACTERISTICS:
  • •Histologically confirmed solid tumor for which there is no known curative therapy or therapy that is known to prolong survival with acceptable quality of life
  • •Histologic requirement waived for intrinsic brain stem tumors
  • •No pleural effusion or ascites
  • •Neurological deficits from CNS tumors must have been relatively stable for at least 1 week prior to study entry
  • •PATIENT CHARACTERISTICS:
  • •Performance status
  • •Karnofsky 50-100% (over 10 years of age)
  • •Lansky 50-100% (10 years of age and under)
  • •Life expectancy
  • •At least 8 weeks
  • •Hematopoietic
  • •Absolute neutrophil count at least 1,000/mm^3
  • •Platelet count at least 100,000/mm^3 (transfusion independent)
  • •Hemoglobin at least 8.0 g/dL (transfusion allowed)
  • •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • •ALT no greater than 2.5 times ULN
  • •Albumin at least 2 g/dL
  • •Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min OR
  • •Creatinine based on age as follows:
  • •No greater than 0.8 mg/dL (age 5 and under)
  • •No greater than 1.0 mg/dL (age 6 to 10)
  • •No greater than 1.2 mg/dL (age 11 to 15)
  • •No greater than 1.5 mg/dL (age 16 and over)
  • •No evidence of dyspnea at rest
  • •No exercise intolerance
  • •Not pregnant or nursing
  • •Negative pregnancy test
  • •Fertile patients must use effective contraception
  • •No evidence of Approved-not yet active graft-versus-host disease
  • •No uncontrolled infection
  • •Seizure disorder allowed provided it is well-controlled with anticonvulsants
  • •CNS toxicity no greater than grade 1
  • •PRIOR CONCURRENT THERAPY:
  • •Biologic therapy
  • •Recovered from prior immunotherapy
  • •At least 7 days since prior antineoplastic biologic therapy
  • •At least 6 months since prior allogeneic stem cell transplantation
  • •More than 1 week since prior growth factors
  • •No concurrent biologic therapy
  • •No concurrent immunotherapy
  • •No concurrent prophylactic growth factor support during course 1
  • •Chemotherapy
  • •No prior pemetrexed disodium
  • •More than 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
  • •No other concurrent chemotherapy
  • •Endocrine therapy
  • •Concurrent dexamethasone for CNS tumors allowed provided dose has been stable or decreasing for at least 1 week prior to study entry
  • •Radiotherapy
  • •Recovered from all prior radiotherapy
  • +9 more not shown

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Event Free Survival

Time Frame: Length of study

Secondary Outcomes

  • Dose Limiting Toxicity(Length of study)
  • Maximum Tolerated Dose(Length of study)

Investigators

Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (20)

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