Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Princess Margaret Hospital

Naomi S. Balzer-Haas

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00121225
Information obtained from ClinicalTrials.gov on December 14, 2011

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