Erlotinib in Combination With Temozolomide in Treating Relapsed/Recurrent/Refractory Pediatric Solid Tumors

Sponsor
Washington University School of Medicine
Study ID
NCT02689336
Phase
PHASE2
Status
Withdrawn

Conditions

  • Ependymoma
  • Ewing's Sarcoma
  • Glioma
  • Medulloblastoma
  • Neuroectodermal Tumor
  • Osteosarcoma
  • Rhabdomyosarcoma
  • Wilms Tumor

Eligibility Criteria

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

Interventions

  • Erlotinib — BIOLOGICAL
  • Temozolomide — DRUG

Study Details

This study proposes to treat patients with the combination of erlotinib and temozolomide. Patients with relapsed, recurrent, refractory, or high risk malignancies whose tumors possess a non-synonymous mutation in EGFR, ERBB2, or JAK2V617F (JAK2) will be eligible for the study. Very few phase 2 clinical trials have been performed in pediatrics using targeted agents in combination with conventional chemotherapy agents. Furthermore, since some combinations such as the combination of this study (erlotinib and temozolomide) have shown additive/synergistic effects in preclinical studies, therapy selecting for those patients who possess mutations targeted by the TKI of the study, may unveil activity that has not been previously observed. Thus, the investigators hope to determine whether the addition of additive/synergistic chemotherapy will increase efficacy of target agent and/or increase tumor susceptibility to targeted agent resulting in increased anti-tumor activity.

Key Dates

First listed
Feb 23, 2016
Start date
Aug 6, 2016
Status verified
Sep 2019
Primary completion
Nov 30, 2019
Completion
May 31, 2020

Study Design

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

Arms

  • Experimental: Erlotinib and Temozolomide
    * Erlotinib is an oral drug that will be administered on an outpatient basis at a dose of 85 mg/m\^2/dose once a day continuously (every day of a 28-day cycle) * Temozolomide is an oral drug that will be administered on an outpatient basis at a dose of 180mg/m2/dose once a day on Days 1-5 of a 28-day cycle.

Primary Outcome Measure

Overall response rate [ Time Frame: Completion of treatment (estimated to be 6 months) ]

Related Studies