Erlotinib and Temozolomide in Treating Young Patients With Recurrent or Refractory Solid Tumors

Part of paid clinical trials in Arcadia, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00077454
Phase
PHASE1
Status
Completed

Conditions

  • Previously Treated Childhood Rhabdomyosarcoma
  • Recurrent Childhood Brain Tumor
  • Recurrent Childhood Cerebellar Astrocytoma
  • Recurrent Childhood Cerebral Astrocytoma
  • Recurrent Childhood Ependymoma
  • Recurrent Childhood Malignant Germ Cell Tumor
  • Recurrent Childhood Medulloblastoma
  • Recurrent Childhood Rhabdomyosarcoma
  • Recurrent Childhood Soft Tissue Sarcoma
  • Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor
  • Recurrent Neuroblastoma
  • Recurrent Osteosarcoma

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • erlotinib hydrochloride — DRUG
    Given orally (PO)
  • temozolomide — DRUG
    Given PO
  • pharmacological study — OTHER
    Correlative studies
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

This phase I trial is studying the side effects and best dose of erlotinib when given with temozolomide in treating young patients with recurrent or refractory solid tumors. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving erlotinib with temozolomide may kill more tumor cells.

Key Dates

First listed
Feb 12, 2004
Start date
Feb 29, 2004
Status verified
Jun 2013
Primary completion
Sep 30, 2007

Study Design

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

Arms

  • Experimental: Treatment (erlotinib hydrochloride, temozolomide)
    Patients receive oral erlotinib once daily on days 1-28. Beginning with course 2, patients also receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 23 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Dose-limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: 56 days (2 courses) ]

Locations (1)

FacilityCityStateZIPSite coordinators
COG Phase I ConsortiumArcadiaCalifornia91006-3776-

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By research site
COG Phase I Consortium· Arcadia, CA

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