RO4929097 in Treating Patients With Stage IV Melanoma



Status:Archived
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:November 2010

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Phase II Study of RO4929097 (NSC-749225) in Advanced Melanoma


RATIONALE: RO4929097 may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth.,

PURPOSE: This phase II trial is studying how well RO4929097 works in treating patients with
stage IV melanoma.


OBJECTIVES:

Primary

- To assess the 6-month progression-free survival and 1-year overall survival of patients
with stage IV melanoma treated with gamma-secretase inhibitor RO4929097.

Secondary

- To investigate, in a preliminary manner, the relationship between Notch activation
status and gene expression profile of tumor and clinical outcomes of patients treated
with this regimen.

- To study the effects of this regimen on T-cell function, which will provide the basis
for subsequent trials combining Notch blockade with immunomodulatory therapy for
advanced melanoma.

- To assess the response rate in patients treated with this regimen.

- To assess the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral gamma-secretase inhibitor RO4929097 on days 1-3, 8-10, and 15-17.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Some patients undergo blood collection at baseline and during study for analysis of T-cell
function by flow cytometry and ELISA. Tumor tissue samples from biopsy or surgery are also
analyzed for Notch activation by IHC and qRT-PCR.

After completion of study therapy, patients are followed up every 3 months for 1 year and
then every 6 months for 2 years.


We found this trial at
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413 Lilly Rd NE
Olympia, Washington 98506
(888) 492-9480
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2720 Clare Avenue
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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2700 Wayne Memorial Drive
Goldsboro, North Carolina 27534
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
(702) 383-2000
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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1415 E. Kincaid
Mount Vernon, Washington 98273
360-424-4111
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19500 10th Ave NE # 100
Poulsbo, Washington 98370
(360) 598-7500
Harrison Poulsbo Hematology and Onocology Harrison Poulsbo's new Hematology & Oncology center provides outpatient cancer...
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
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1959 NE Pacific St
Seattle, Washington 98195
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201 16th Avenue East
Seattle, Washington 98112
(206) 326-3000
Group Health Central Hospital Group Health Cooperative is a member-governed, nonprofit health care system that...
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601 South Sherman Street
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820 North Chelan Avenue
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Ann Arbor, Michigan 48106
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
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300 North Ave
Battle Creek, Michigan 49017
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205 Palmer Ave.
Bellefontaine, Ohio 43311
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605 Oak St
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801 N. 29th St
Billings, Montana 59107
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1101 N 27th St # 201
Billings, Montana 59101
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211 Saint Francis Drive
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272 Hospital Rd
Chillicothe, Ohio 45601
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Richmond, Indiana 47374
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