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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014