Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00121225
First received: July 19, 2005
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
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
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Vorinostat in Patients With Advanced Melanoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate assessed by Response Evaluation Criteria for Solid Tumors (RECIST) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 32
Study Start Date: September 2005
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: vorinostat
Other Names:
  • L-001079038
  • SAHA
  • suberoylanilide hydroxamic acid
  • Zolinza

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121225

Locations
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Fox Chase Cancer Center
Rockledge, Pennsylvania, United States, 19046
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Princess Margaret Hospital Phase 2 Consortium
Toronto, Ontario, Canada, M5G 2M9
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Investigators
Principal Investigator: Naomi Balzer-Haas Princess Margaret Hospital Phase 2 Consortium
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00121225     History of Changes
Other Study ID Numbers: NCI-2009-00099, PHL-040, CDR0000436851, N01CM62203
Study First Received: July 19, 2005
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases
Vorinostat
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014