Oxaliplatin in Treating Children With Advanced Solid Tumors
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: oxaliplatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Oxaliplatin in Children With Solid Tumors |
| Enrollment: | 26 |
| Study Start Date: | April 2000 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105-2794 | |
| Study Chair: | Sheri L. Spunt, MD | St. Jude Children's Research Hospital |
More Information
Additional Information:
Publications:
| Responsible Party: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT00005844 History of Changes |
| Other Study ID Numbers: | CDR0000067860, SJCRH-OXAL1, NCI-T99-0059 |
| Study First Received: | June 2, 2000 |
| Last Updated: | October 22, 2012 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by St. Jude Children's Research Hospital:
|
unspecified childhood solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasms Oxaliplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013