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A Phase I Study of Oxaliplatin in Children With Solid Tumors


Phase 1
N/A
21 Years
Not Enrolling
Both
Unspecified Childhood Solid Tumor, Protocol Specific

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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 HospitalMemphis, Tennessee  38105-2794