Oxaliplatin in Treating Children With Advanced Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00005844
First received: June 2, 2000
Last updated: October 22, 2012
Last verified: October 2012

June 2, 2000
October 22, 2012
April 2000
September 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00005844 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Oxaliplatin in Treating Children With Advanced Solid Tumors
A Phase I Study of Oxaliplatin in Children With Solid Tumors

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: oxaliplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005844
CDR0000067860, SJCRH-OXAL1, NCI-T99-0059
No
St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
National Cancer Institute (NCI)
Study Chair: Sheri L. Spunt, MD St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP