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Sponsors and Collaborators: |
St. Jude Children's Research Hospital National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005844 |
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 |
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Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: oxaliplatin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Oxaliplatin in Children With Solid Tumors |
Study Start Date: | August 2000 |
OBJECTIVES:
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.
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
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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 |
Study ID Numbers: | CDR0000067860, SJCRH-OXAL1, NCI-T99-0059 |
Study First Received: | June 2, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005844 History of Changes |
Health Authority: | United States: Federal Government |
unspecified childhood solid tumor, protocol specific |
Oxaliplatin |
Oxaliplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |