Patient case: 11-year-old male with Peutz-Jeghers syndrome; genetic feature: STK11

Clinical trial: Oxaliplatin in Treating Children With Advanced Solid Tumors

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.

Eligibility: 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

Relevance to patient case: not relevant