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RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer

NCT01217411 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-11-19

Study results available
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Summary

This randomized phase I/II trial studies the side effects and the best dose of RO4929097 (gamma-secretase/Notch signalling pathway inhibitor RO4929097) when given together with whole-brain radiation therapy or stereotactic radiosurgery and to see how well it works compared to whole-brain radiation therapy or stereotactic radiosurgery alone in treating patients with breast cancer or other cancers (such as lung cancer or melanoma) that have spread to the brain. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Whole-brain radiation therapy uses high energy x-rays deliver radiation to the entire brain to treat tumors that can and cannot be seen. Stereotactic radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known whether giving RO4929097 together with whole-brain radiation therapy or stereotactic radiosurgery may kill more tumor cells.

Conditions

  • Adult Solid Neoplasm
  • Extensive Stage Lung Small Cell Carcinoma
  • HER2/Neu Negative
  • HER2/Neu Positive
  • Male Breast Carcinoma
  • Metastatic Malignant Neoplasm in the Brain
  • Recurrent Breast Carcinoma
  • Recurrent Lung Non-Small Cell Carcinoma
  • Recurrent Lung Small Cell Carcinoma
  • Recurrent Melanoma
  • Stage IV Breast Cancer AJCC v6 and v7
  • Stage IV Cutaneous Melanoma AJCC v6 and v7
  • Stage IV Lung Non-Small Cell Cancer AJCC v7

Interventions

PROCEDURE

Cognitive Assessment

Ancillary studies

DRUG

Gamma-Secretase Inhibitor RO4929097

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

RADIATION

Stereotactic Radiosurgery

Undergo SRS

RADIATION

Whole-Brain Radiotherapy

Undergo WBRT

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Morris D Groves · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-01
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01217411 on ClinicalTrials.gov