Vismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma

Summary

This randomized phase I/II clinical trial is studying the side effects and best dose of gamma-secretase/notch signalling pathway inhibitor RO4929097 when given together with vismodegib and to see how well they work in treating patients with advanced or metastatic sarcoma. Vismodegib may slow the growth of tumor cells. Gamma-secretase/notch signalling pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vismodegib together with gamma-secretase/notch signalling pathway inhibitor RO4929097 may be an effective treatment for sarcoma.

Conditions

• Adult Alveolar Soft Part Sarcoma
• Adult Angiosarcoma
• Adult Desmoplastic Small Round Cell Tumor
• Adult Epithelioid Hemangioendothelioma
• Adult Epithelioid Sarcoma
• Adult Extraskeletal Myxoid Chondrosarcoma
• Adult Extraskeletal Osteosarcoma
• Adult Fibrosarcoma
• Adult Leiomyosarcoma
• Adult Liposarcoma
• Adult Malignant Mesenchymoma
• Adult Malignant Peripheral Nerve Sheath Tumor
• Adult Rhabdomyosarcoma
• Adult Synovial Sarcoma
• Adult Unclassified Pleomorphic Sarcoma
• Chondrosarcoma
• Clear Cell Sarcoma of the Kidney
• Conjunctival Kaposi Sarcoma
• Dermatofibrosarcoma Protuberans
• Gastrointestinal Stromal Tumor
• Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
• Metastatic Osteosarcoma
• Ovarian Sarcoma
• Recurrent Adult Soft Tissue Sarcoma
• Recurrent Adult Unclassified Pleomorphic Sarcoma of Bone
• Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
• Recurrent Kaposi Sarcoma
• Recurrent Osteosarcoma
• Recurrent Uterine Corpus Sarcoma
• Small Intestine Leiomyosarcoma
• Stage III Adult Soft Tissue Sarcoma
• Stage III Uterine Sarcoma
• Stage IV Adult Soft Tissue Sarcoma
• Stage IV Uterine Sarcoma
• Unclassified Pleomorphic Sarcoma of Bone

Interventions

DRUG

Gamma-Secretase Inhibitor RO4929097

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacological Study

Correlative studies

DRUG

Vismodegib

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Mrinal Gounder · Memorial Sloan Kettering 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

2010-06-30

Primary Completion

2015-02-28

Completion

2015-02-28

Countries

• United States

Study Locations