Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma

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Brief Title

Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma

Official Title

A Phase II Study of Vorinostat in Patients With Advanced Melanoma

Brief Summary

      This phase II trial is studying how well vorinostat works in treating patients with
      metastatic or unresectable melanoma. Vorinostat may stop the growth of tumor cells by
      blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
    

Detailed Description

      PRIMARY OBJECTIVE:

      I. Determine the objective response rate in patients with metastatic or unresectable melanoma
      treated with vorinostat.

      SECONDARY OBJECTIVES:

      I. Determine time to progression in patients treated with this drug. II. Determine the
      utility of HP1 and/or macro H2A nuclear foci as biomarkers of response in patients treated
      with this drug.

      III. Correlate the presence of 72R or 72P variant p53 polymorphisms with response and time to
      progression in patients treated with this drug.

      IV. Determine gene expression profiles that may predict response to this drug and gene
      expression changes that occur after treatment with this drug in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive oral vorinostat once daily on days 1-28. Courses repeat every 28 days in the
      absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed for 4 weeks and then every 3
      months thereafter.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Objective Response Rate Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)

Secondary Outcome

 Time to Progression Assessed by RECIST

Condition

Ciliary Body and Choroid Melanoma, Medium/Large Size

Intervention

vorinostat

Study Arms / Comparison Groups

 Arm I
Description:  Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

32

Start Date

September 2005

Completion Date

June 2013

Primary Completion Date

March 2009

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically/cytologically confirmed melanoma that is metastatic/unresectable

          -  Residual, recurrent, or metastatic disease by radiographic examination. Measurable
             disease (at least 1 lesion in at least 1 dimension (longest diameter) as >20mm with
             conventional techniques or >10mm with spiral CT scan, within 4 weeks prior to
             registration

          -  No prior therapy or 1 prior treatment (cytokine/chemotherapy/combination) for
             metastatic disease allowed. Patients should not take valproic acid, another histone
             deacetylase inhibitor, for at least 2 weeks prior to enrollment. At least 4 weeks from
             prior therapy to be eligible or 6 weeks if last regimen included BCNU or mitomycin C

          -  Age>=18 years

          -  Life expectancy >=3 months.

          -  ECOG<2 (Karnofsky ≥60%)

          -  Leukocytes >3,000/mcL

          -  Absolute neutrophil count >1,500/mcL

          -  Platelets >100,000/mcL

          -  Total bilirubin within institutional limits

          -  AST/ALT≤2.5Xinstitutional ULN

          -  Creatinine within institutional limits OR creatinine clearance >60mL/min/1.73 m2 if
             creatinine levels above institutional limits

          -  Eligibility of patients taking medications with potential to affect activity/PK of
             Vorinostat will be determined by PI

          -  Must not use concomitant steroids except topical/inhaled use

          -  Vorinostat effects on developing human fetus are unknown. Women of childbearing
             potential (WOCBP) and sexually active males must agree to use accepted/effective
             contraception method prior to study entry and for duration of the study

          -  Ability to understand/willingness to sign written informed consent

          -  Must have paraffin block of tumor tissue available for future studies

        Exclusion Criteria:

          -  Chemotherapy/radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C)
             prior to entering study

          -  May not be receiving any other investigational agents

          -  Known brain metastases

          -  History of allergic reactions attributed to compounds of similar chemical/biologic
             composition to Vorinostat

          -  Uncontrolled intercurrent illness including but not limited to ongoing/active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant women excluded because Vorinostat is a HDAC inhibitor agent with potential
             for teratogenic or abortifacient effects

          -  HIV-positive patients receiving combination antiretroviral therapy are ineligible
             because of potential for PK interactions with Vorinostat
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Naomi Balzer-Haas, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00121225

Organization ID

NCI-2009-00099

Secondary IDs

PHL-040

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Naomi Balzer-Haas, Principal Investigator, Princess Margaret Hospital Phase 2 Consortium


Verification Date

January 2019