A Phase I Study of Oxaliplatin in Children With Solid Tumors
N/A
21 Years
Both
Unspecified Childhood Solid Tumor, Protocol Specific
Trial Information
A Phase I Study of Oxaliplatin in Children With Solid Tumors
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.
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Sheri L. Spunt, MD
Investigator Role:
Study Chair
Investigator Affiliation:
St. Jude Children's Research Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000067860
NCT ID:
NCT00005844
Start Date:
April 2000
Completion Date:
September 2007
Related Keywords:
- Unspecified Childhood Solid Tumor, Protocol Specific
- unspecified childhood solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
