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Clinical Trials/NCT00101270
NCT00101270
Completed
Phase 1

A Phase I Study of Oxaliplatin (NSC# 266046, IND #57004) and Irinotecan in Pediatric Patients With Refractory Solid Tumors and Lymphomas

National Cancer Institute (NCI)1 site in 1 country24 target enrollmentMarch 2005
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ConditionsChildhood Burkitt LymphomaChildhood Central Nervous System Germ Cell TumorChildhood Diffuse Large Cell LymphomaChildhood Grade III Lymphomatoid GranulomatosisChildhood Immunoblastic Large Cell LymphomaRecurrent Childhood Brain Stem GliomaRecurrent Childhood Cerebellar AstrocytomaRecurrent Childhood Cerebral AstrocytomaRecurrent Childhood EpendymomaRecurrent Childhood Grade III Lymphomatoid GranulomatosisRecurrent Childhood Large Cell LymphomaRecurrent Childhood Liver CancerRecurrent Childhood Lymphoblastic LymphomaRecurrent Childhood Malignant Germ Cell TumorRecurrent Childhood MedulloblastomaRecurrent Childhood RhabdomyosarcomaRecurrent Childhood Small Noncleaved Cell LymphomaRecurrent Childhood Soft Tissue SarcomaRecurrent Childhood Supratentorial Primitive Neuroectodermal TumorRecurrent Childhood Visual Pathway GliomaRecurrent Colon CancerRecurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorRecurrent MelanomaRecurrent Nasopharyngeal CancerRecurrent NeuroblastomaRecurrent OsteosarcomaRecurrent Wilms Tumor and Other Childhood Kidney TumorsRecurrent/Refractory Childhood Hodgkin LymphomaUnspecified Childhood Solid Tumor, Protocol Specific
Interventionsirinotecan hydrochlorideoxaliplatin
Drugsirinotecan hydrochlorideoxaliplatin

Overview

Phase
Phase 1
Intervention
irinotecan hydrochloride
Conditions
Childhood Burkitt Lymphoma
Sponsor
National Cancer Institute (NCI)
Enrollment
24
Locations
1
Primary Endpoint
MTD of oxaliplatin, defined as the maximum dose at which fewer than one-third of patients experience DLT
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

This phase I trial is studying the side effects and best dose of oxaliplatin when given together with irinotecan in treating young patients with refractory solid tumors or lymphomas. Drugs used in chemotherapy, such as oxaliplatin and irinotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Oxaliplatin may help irinotecan kill more cancer cells by making cancer cells more sensitive to the drug. Giving oxaliplatin together with irinotecan may kill more cancer cells.

Detailed Description

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of oxaliplatin when administered with irinotecan in pediatric patients with refractory solid tumors or lymphomas. II. Determine the toxic effects of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients. SECONDARY OBJECTIVES: I. Determine, preliminarily, the antitumor activity of this regimen in these patients. II. Correlate UGT and BCRP genotype with the toxicity of this regimen in these patients. OUTLINE: This is a multicenter, dose-escalation study of oxaliplatin. Patients receive oxaliplatin IV over 2 hours on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 17 courses 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 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Registry
clinicaltrials.gov
Start Date
March 2005
End Date
September 2007
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Histologically confirmed refractory malignant solid tumor or lymphoma
  • •Intrinsic brain stem tumors and optic pathway tumors do not require histologic verification
  • •No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists
  • •Measurable or evaluable disease
  • •Evaluable disease is defined as a tumor that cannot be measured using a ruler or calipers, but can be assessed to determine disease progression or complete response, such as any of the following:
  • •Positive lesions on metaiodobenzylguanidine (MIBG) or bone scan
  • •Metastatic bone marrow disease
  • •Elevated tumor markers
  • •Presence of a malignant pleural effusion
  • •No leukemia

Exclusion Criteria

  • Not provided

Arms & Interventions

Treatment (irinotecan hydrochloride, oxaliplatin)

Patients receive oxaliplatin IV over 2 hours on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

Intervention: irinotecan hydrochloride

Treatment (irinotecan hydrochloride, oxaliplatin)

Patients receive oxaliplatin IV over 2 hours on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

Intervention: oxaliplatin

Outcomes

Primary Outcomes

MTD of oxaliplatin, defined as the maximum dose at which fewer than one-third of patients experience DLT

Time Frame: 21 days

Graded using the NCI CTCAE version 3.0.

Secondary Outcomes

  • Overall response assessed using RECIST criteria(Up to 12 months)

Study Sites (1)

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