Oxaliplatin in Treating Children With Advanced Solid Tumors

St. Jude Children's Research Hospital

Status and phase: Completed; Phase 1

Conditions: Unspecified Childhood Solid Tumor, Protocol Specific

Treatments: Drug: oxaliplatin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00005844

SJCRH-OXAL1 (Other Identifier)

NCI-T99-0059 (Other Identifier)

CDR0000067860

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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