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A Phase II Study of Vorinostat in Patients With Advanced Melanoma

Phase 2
18 Years
Open (Enrolling)
Ciliary Body and Choroid Melanoma, Medium/Large Size, Extraocular Extension Melanoma, Iris Melanoma, Metastatic Intraocular Melanoma, Recurrent Intraocular Melanoma, Recurrent Melanoma, Stage IV Melanoma

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Trial Information

A Phase II Study of Vorinostat in Patients With Advanced Melanoma


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.

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate assessed by Response Evaluation Criteria for Solid Tumors (RECIST)

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Naomi Balzer-Haas

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital Phase 2 Consortium


United States: Food and Drug Administration

Study ID:




Start Date:

September 2005

Completion Date:

Related Keywords:

  • Ciliary Body and Choroid Melanoma, Medium/Large Size
  • Extraocular Extension Melanoma
  • Iris Melanoma
  • Metastatic Intraocular Melanoma
  • Recurrent Intraocular Melanoma
  • Recurrent Melanoma
  • Stage IV Melanoma
  • Melanoma
  • Uveal Neoplasms



Fox Chase Cancer Center Philadelphia, Pennsylvania  19111