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
  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 oxaliplatin in treating children who have advanced solid tumors.


Condition Intervention Phase
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: oxaliplatin
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of Oxaliplatin in Children With Solid Tumors

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Enrollment: 26
Study Start Date: April 2000
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005844

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Study Chair: Sheri L. Spunt, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
Publications:
Iacono LC, Spunt SL, Pratt CB, et al.: Pharmacokinetics of oxaliplatin in children with solid tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2170, 89b, 2002.
Pratt CB, Spunt SL, Thompson SJ, et al.: Phase I Study of Oxaliplatin in Pediatric Patients with Malignant Solid Tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1498, 2001.

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00005844     History of Changes
Other Study ID Numbers: CDR0000067860, SJCRH-OXAL1, NCI-T99-0059
Study First Received: June 2, 2000
Last Updated: October 22, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by St. Jude Children's Research Hospital:
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014