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Status:

WITHDRAWN

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

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Stage IIIB Melanoma

Stage IIIC Melanoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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...

Detailed Description

PRIMARY OBJECTIVES: I. Evaluate the molecular effects of Notch signaling inhibition using gamma-secretase inhibitor RO4929097 (RO4929097) in patients with resectable stage IIIB, IIIC, or IV intact me...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • 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
  • No uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia, or hypokalemia despite adequate electrolyte supplementation
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia other than chronic
  • Unstable atrial fibrillation
  • Psychiatric illness and/or social situations that would limit compliance with study requirements
  • No baseline QTcF \> 450 msec (male) or QTcF \> 470 msec (female)
  • No history of cancer within the past 5 years except curatively treated basal or squamous cell cancer of the skin, in situ cervical cancer, or lobular carcinoma in situ of the breast
  • No other concurrent anticancer agents or therapies
  • More than 4 weeks since prior immunotherapy or local radiotherapy and recovered
  • No prior chemotherapy for melanoma
  • No concurrent medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin®)
  • No concurrent medications that are strong inducers/inhibitors or substrates of CYP3A4
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent ketoconazole or grapefruit juice while taking gamma-secretase inhibitor RO4929097
  • No concurrent granulocyte colony-stimulating factors
  • No other concurrent investigational agents

Exclusion

    Key Trial Info

    Start Date :

    September 1 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT01216787

    Start Date

    September 1 2010

    Last Update

    January 31 2013

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    New York University Langone Medical Center

    New York, New York, United States, 10016

    2

    Montefiore Medical Center

    The Bronx, New York, United States, 10467-2490