NCT00005844

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2000

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

October 23, 2012

Status Verified

October 1, 2012

Enrollment Period

7.4 years

First QC Date

June 2, 2000

Last Update Submit

October 22, 2012

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified childhood solid tumor, protocol specific

Interventions

oxaliplatinDRUG

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105-2794, United States

Location

Related Publications (3)

  • 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. doi: 10.1200/JCO.2006.08.2388.

    PMID: 17538173RESULT

  • 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.

    RESULT

  • 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.

    RESULT

Related Links

MeSH Terms

Interventions

Oxaliplatin

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Sheri L. Spunt, MD

    St. Jude Children's Research Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2000

First Posted

January 27, 2003

Study Start

April 1, 2000

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

October 23, 2012

Record last verified: 2012-10

Locations

US(1)