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Oxaliplatin in Treating Children With Advanced Solid Tumors

Sponsor
St. Jude Children's Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00005844
Collaborator
National Cancer Institute (NCI) (NIH)
26
Enrollment
1
Location
89
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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 oxaliplatin in treating children who have advanced solid tumors.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose of oxaliplatin in children with advanced solid tumors.

  • Determine the toxic effects of this drug in these patients.

  • Determine the safety of this drug in these patients.

  • Determine the pharmacokinetics of this drug in these patients.

  • Assess the relationship between pharmacokinetic parameters and toxicity of this regimen and response in these patients.

  • Determine the anti-tumor effects of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oxaliplatin IV over 2 hours on day 1 (every 3 weeks for up to 6 courses) OR on days 1, 14, and 28 (every 6 weeks for up to 3 courses). Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated dose (MTD) is determined. 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.

Once the MTD for dose levels 1-4 is determined, an additional cohort of 3-6 patients is accrued and treated with oxaliplatin as above every 2 weeks (for up to 9 doses).

PROJECTED ACCRUAL: Approximately 6-20 patients will be accrued for this study within 1-3.3 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Primary Purpose:
Treatment
Official Title:
A Phase I Study of Oxaliplatin in Children With Solid Tumors
Study Start Date :
Apr 1, 2000
Actual Primary Completion Date :
Sep 1, 2007
Actual Study Completion Date :
Sep 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically confirmed metastatic or unresectable solid tumors that are not amenable to standard treatment

    • Histological confirmation not required for brain stem tumors

    • No known brain metastases

    • No leukemia

    PATIENT CHARACTERISTICS:
    Age:
    • 21 and under
    Performance status:

    • ECOG 0-2 OR

    • Lansky 50-100%

    Life expectancy:
    • Not specified
    Hematopoietic:

    • Absolute neutrophil count at least 1,000/mm^3 (except with marrow involvement)

    • Hemoglobin at least 8 g/dL

    • Platelet count at least 100,000/mm^3

    Hepatic:

    • Bilirubin 0.2-1.4 mg/dL

    • AST/ALT no greater than 3 times upper limit of normal

    Renal:

    • Creatinine normal for age OR

    • Creatinine clearance at least 50 mL/min

    • Electrolytes, calcium, and phosphorus normal

    Cardiovascular:
    • No symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia
    Other:

    • Not pregnant or nursing

    • Fertile patients must use effective contraception

    • HIV negative

    • No active graft-vs-host disease (GVHD)

    • No allergy to platinum compounds or antiemetics

    • No uncontrolled concurrent illness or infection

    • No evidence of neuropathy

    • Blood sugar normal

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:

    • At least 1 week since prior hematopoietic growth factors

    • At least 3 months since prior stem cell transplantation and recovered

    Chemotherapy:
    • At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea)
    Endocrine therapy:
    • Not specified
    Radiotherapy:

    • At least 6 weeks since prior extensive radiotherapy to significant marrow-containing compartment

    • At least 6 months since prior craniospinal radiotherapy; total abdominal, pelvic, or extensive lung radiotherapy; or mantle and Y-port radiotherapy

    • At least 6 months since prior total body irradiation

    Surgery:
    • Not specified
    Other:

    • No concurrent therapy for GVHD

    • No other concurrent anticancer investigational or commercial agents

    • No other concurrent anticancer therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Jude Children's Research Hospital Memphis Tennessee United States 38105-2794

    Sponsors and Collaborators

    • St. Jude Children's Research Hospital
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Sheri L. Spunt, MD, St. Jude Children's Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    St. Jude Children's Research Hospital
    ClinicalTrials.gov Identifier:
    NCT00005844
    Other Study ID Numbers:
    • CDR0000067860
    • SJCRH-OXAL1
    • NCI-T99-0059
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Oct 23, 2012
    Last Verified:
    Oct 1, 2012
    Keywords provided by St. Jude Children's Research Hospital
    unspecified childhood solid tumor, protocol specific
    Additional relevant MeSH terms:
    Neoplasms
    Oxaliplatin

    Study Results

    No Results Posted as of Oct 23, 2012