Oxaliplatin in Treating Children With Advanced Solid Tumors - Full Text View

Sponsor:	St. Jude Children's Research Hospital
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00005844

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 I

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	A Phase I Study of Oxaliplatin in Children With Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Oxaliplatin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

August 2000

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

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005844

Locations

United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794

Sponsors and Collaborators

St. Jude Children's Research Hospital

National Cancer Institute (NCI)

Investigators

Study Chair:

Sheri L. Spunt, MD

St. Jude Children's Research Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Spunt SL, Freeman BB 3rd, Billups CA, McPherson V, Khan RB, Pratt CB, Stewart CF. Phase I clinical trial of oxaliplatin in children and adolescents with refractory solid tumors. J Clin Oncol. 2007 Jun 1;25(16):2274-80.

Iacono LC, Spunt SL, Pratt CB, et al.: Pharmacokinetics of oxaliplatin in children with solid tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2170, 89b, 2002.

Pratt CB, Spunt SL, Thompson SJ, et al.: Phase I Study of Oxaliplatin in Pediatric Patients with Malignant Solid Tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1498, 2001.

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:	July 23, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:

Neoplasms
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012