Oxaliplatin and Irinotecan in Treating Young Patients With Refractory Solid Tumors or Lymphomas

Part of paid clinical trials in Arcadia, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00101270
Phase
PHASE1
Status
Completed

Conditions

  • Childhood Burkitt Lymphoma
  • Childhood Central Nervous System Germ Cell Tumor
  • Childhood Diffuse Large Cell Lymphoma
  • Childhood Grade III Lymphomatoid Granulomatosis
  • Childhood Immunoblastic Large Cell Lymphoma
  • Recurrent Childhood Brain Stem Glioma
  • Recurrent Childhood Cerebellar Astrocytoma
  • Recurrent Childhood Cerebral Astrocytoma
  • Recurrent Childhood Ependymoma
  • Recurrent Childhood Grade III Lymphomatoid Granulomatosis
  • Recurrent Childhood Large Cell Lymphoma
  • Recurrent Childhood Liver Cancer
  • Recurrent Childhood Lymphoblastic Lymphoma
  • Recurrent Childhood Malignant Germ Cell Tumor
  • Recurrent Childhood Medulloblastoma
  • Recurrent Childhood Rhabdomyosarcoma
  • Recurrent Childhood Small Noncleaved Cell Lymphoma
  • Recurrent Childhood Soft Tissue Sarcoma
  • Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor
  • Recurrent Childhood Visual Pathway Glioma
  • Recurrent Colon Cancer
  • Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Recurrent Melanoma
  • Recurrent Nasopharyngeal Cancer
  • Recurrent Neuroblastoma
  • Recurrent Osteosarcoma
  • Recurrent Wilms Tumor and Other Childhood Kidney Tumors
  • Recurrent/Refractory Childhood Hodgkin Lymphoma
  • Unspecified Childhood Solid Tumor, Protocol Specific

Eligibility Criteria

Sex
ALL
Age
1 Year - 21 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 31, 2005
Status verified
Jun 2013
Primary completion
Sep 30, 2007

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

MTD of oxaliplatin, defined as the maximum dose at which fewer than one-third of patients experience DLT [ Time Frame: 21 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
COG Phase I ConsortiumArcadiaCalifornia91006-3776-

Find similar trials in Arcadia, CA

By research site
COG Phase I Consortium· Arcadia, CA

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