Completed PHASE1 INTERVENTIONAL 1-arm NCT00077454

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

A Phase I Study of Single Agent OSI-774 (Tarceva) (NSC# 718781, IND# 63383) Followed by OSI-774 With Temozolomide for Patients With Selected Recurrent/Refractory Solid Tumors, Including Brain Tumors

Sponsor: National Cancer Institute (NCI)

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

Interventions erlotinib hydrochloride laboratory biomarker analysis pharmacological study temozolomide

Updated 6 times since 2017 Last updated: Jun 4, 2013 Started: Feb 29, 2004 Primary completion: Sep 30, 2007

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Previously Treated Childhood Rhabdomyosarcoma and Recurrent Childhood Brain Tumor and is currently completed. National Cancer Institute (NCI) leads this study, which shows 6 recorded versions since 2004 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed PHASE1

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

Feb 2004

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

National Cancer Institute (NCI)

Data source: National Cancer Institute (NCI)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Arcadia, United States