Oxaliplatin in Treating Children With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Collaborator: National Cancer Institute (NCI)
• Treatments: Oxaliplatin

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