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Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma
This study is ongoing, but not recruiting participants.
First Received: July 19, 2005   Last Updated: April 14, 2009   History of Changes
Sponsor: Princess Margaret Hospital, Canada
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00121225
  Purpose

RATIONALE: 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.

PURPOSE: This phase II trial is studying how well vorinostat works in treating patients with metastatic or unresectable melanoma.


Condition Intervention Phase
Intraocular Melanoma
Melanoma (Skin)
Drug: vorinostat
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Suberoylanilide Hydroxamic Acid (SAHA) in Advanced Melanoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Objective response rate using measurable disease as measured by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]
  • Progression-free survival at 2 months [ Designated as safety issue: No ]
  • Effect of vorinostat on HP1 and macro H2A nuclear foci [ Designated as safety issue: No ]
  • Effect of vorinostat on vascular endothelial growth factor and basic fibroblast growth factor [ Designated as safety issue: No ]
  • Correlation of WT, 72R, and 72P p53 alleles with response [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: September 2005
Estimated Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • Determine time to progression in patients treated with this drug.
  • Determine the utility of HP1 and/or macro H2A nuclear foci as biomarkers of response in patients treated with this drug.
  • Correlate the presence of 72R or 72P variant p53 polymorphisms with response and time to progression in patients treated with this drug.
  • 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.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 10-16 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • At least 3 months

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal

Renal

  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • 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 CONCURRENT THERAPY:

Biologic therapy

  • 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

Chemotherapy

  • See Biologic therapy
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

  • No concurrent steroids except topical or inhaled steroids

Radiotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy and recovered

Surgery

  • Not specified

Other

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121225

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Naomi S. Balzer-Haas, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: Princess Margaret Hospital ( Amit M. Oza )
Study ID Numbers: CDR0000436851, PMH-PHL-040, NCI-6916
Study First Received: July 19, 2005
Last Updated: April 14, 2009
ClinicalTrials.gov Identifier: NCT00121225     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage IV melanoma
recurrent intraocular melanoma
metastatic intraocular melanoma
iris melanoma
extraocular extension melanoma
ciliary body and choroid melanoma, medium/large size

Additional relevant MeSH terms:
Anticarcinogenic Agents
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Melanoma
Neoplasms by Site
Sensory System Agents
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Nevi and Melanomas
Analgesics
Neoplasms by Histologic Type
Eye Neoplasms
Eye Diseases
Vorinostat
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010