Oxaliplatin in Treating Children With Advanced Solid Tumors

NCT ID: NCT00005844

Last Updated: 2012-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-04-30
• Study Completion Date: 2007-09-30

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.

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.

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified childhood solid tumor, protocol specific

Study Design

• Primary Study Purpose: TREATMENT

Interventions

oxaliplatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheri L. Spunt, MD

Role: STUDY_CHAIR

St. Jude Children's Research Hospital

Locations

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Countries

United States

References

Spunt SL, Freeman BB 3rd, Billups CA, McPherson V, Khan RB, Pratt CB, Stewart CF. Phase I clinical trial of oxaliplatin in children and adolescents with refractory solid tumors. J Clin Oncol. 2007 Jun 1;25(16):2274-80. doi: 10.1200/JCO.2006.08.2388.

Reference Type: RESULT

PMID: 17538173 (View on PubMed)

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.

Reference Type: RESULT

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.

Reference Type: RESULT

Related Links

http://stjude.org

St. Jude Children's Research Hospital

Other Identifiers

SJCRH-OXAL1

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-T99-0059

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000067860

Identifier Type: -

Identifier Source: org_study_id