Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
First received: July 19, 2005
Last updated: May 6, 2013
Last verified: May 2013

July 19, 2005
May 6, 2013
September 2005
March 2009   (final data collection date for primary outcome measure)
Objective response rate assessed by Response Evaluation Criteria for Solid Tumors (RECIST) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00121225 on ClinicalTrials.gov Archive Site
  • Time to progression assessed by RECIST [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Effect of Vorinostat on HP1 and macroH2A nuclear foci [ Time Frame: Baseline and day 15 ] [ Designated as safety issue: No ]
    Compared with Fisher's exact test to determine utility as biomarkers of response.
  • Incidence of p53 allelic variations (72R or 72P) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Compared using Fisher's exact test with response.
  • Effect of Vorinostat on serum levels of VEGF and b-FGF [ Time Frame: Baseline, day 8 and day 15 ] [ Designated as safety issue: No ]
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Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma
A Phase II Study of Vorinostat in Patients With Advanced Melanoma

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.


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


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.

Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ciliary Body and Choroid Melanoma, Medium/Large Size
  • Extraocular Extension Melanoma
  • Iris Melanoma
  • Metastatic Intraocular Melanoma
  • Recurrent Intraocular Melanoma
  • Recurrent Melanoma
  • Stage IV Melanoma
Drug: vorinostat
Other Names:
  • L-001079038
  • SAHA
  • suberoylanilide hydroxamic acid
  • Zolinza
Experimental: Arm I
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.
Intervention: Drug: vorinostat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Active, not recruiting
Not Provided
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Life expectancy at least 3 months
  • Bilirubin normal
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to suberoylanilide hydroxamic acid
  • No other uncontrolled illness
  • Prior adjuvant interferon for stage II or stage III disease allowed
  • Prior vaccine therapy as adjuvant therapy or for metastatic disease allowed
  • No more than 1 prior cytokine and/or chemotherapy regimen for metastatic disease
  • No concurrent prophylactic hematopoietic colony-stimulating factors except erythropoietin
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No concurrent steroids except topical or inhaled steroids
  • More than 4 weeks since prior radiotherapy and recovered
  • At least 2 weeks since prior valproic acid
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies
  • Histologically or cytologically confirmed melanoma (metastatic or unresectable disease)
  • The following melanoma types are allowed:

    • Cutaneous
    • Mucosal
    • Ocular
    • Unknown primary
  • Evidence of residual, recurrent, or metastatic disease by radiographic examination
  • Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan (tumor lesions located within a previously irradiated volume that are the only site of measurable disease must have clear evidence of progression)
  • WBC >= 3,000/mm^3
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • AST and ALT =< 2.5 times upper limit of normal
  • ECOG 0-2 OR Karnofsky 60-100%
  • No known brain metastases
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
NCI-2009-00099, PHL-040, CDR0000436851, N01CM62203
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Naomi Balzer-Haas Princess Margaret Hospital Phase 2 Consortium
National Cancer Institute (NCI)
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP