RO4929097 in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma That Can Be Removed by Surgery

Withdrawn before enrolling · Phase 2

Conditions studied: Stage IIIB Melanoma, Stage IIIC Melanoma, Stage IV Melanoma

In brief

This pilot phase II trial is studying how well RO4929097 works in treating patients with stage III, or stage IV melanoma that can be removed by surgery. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Key facts

Study ID

NCT01216787

Run by

National Cancer Institute (NCI)

People needed

0

Starts

2010-09-01

Last updated by the study team

2013-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed melanoma
• Stage IIIB, IIIC, or IV disease
• Disease that is deemed resectable by surgical consultation
• Patients must agree to pretreatment biopsies of their tumor
• Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques OR as ≥ 10 mm by spiral CT scan
• Measurable lesions must be deemed resectable
• Skin metastases must be photographed and measured
• No non-target disease
• No known brain metastases
• Life expectancy > 3 months
• ECOG performance status 0-2 (Karnofsky 60-100%)
• WBC ≥ 3,000/mm³
• ANC ≥ 1,500/mm³
• Platelet count ≥ 75,000/mm³
• Hemoglobin > 10 g/dL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
• Fertile patients must agree to use 2 forms of contraception (i.e., barrier contraception and 1 other method of contraception) for ≥ 4 weeks prior to, during, and for ≥ 12 months post-treatment
• Negative pregnancy test
• Not pregnant or nursing
• No history of allergic reactions attributed to compounds of similar chemical or biological composition of gamma-secretase inhibitor RO4929097 or other agents used in the study
• No malabsorption syndrome or other condition that would interfere with intestinal absorption
• Able to swallow tablets
• No known history of hepatitis or have a history of liver disease or other forms of cirrhosis

Where it is running

• New York University Langone Medical Center — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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