Melanoma |
Melanoma cancer |
Clinical Trial: Suberoylanilide Hydroxamic Acid in Treating Patients with Metastatic Or Unresectable Melanoma
This study is not yet open for patient recruitment.
Purpose
RATIONALE: Suberoylanilide hydroxamic acid 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 suberoylanilide hydroxamic acid works in treating patients with metastatic or unresectable melanoma.
| Condition | Intervention | Phase |
|---|---|---|
| Recurrent Melanoma Stage IV Melanoma recurrent intraocular melanoma iris melanoma extraocular extension melanoma ciliary body and choroid melanoma, medium/large size | Drug: suberoylanilide hydroxamic acid Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: biological response modifier therapy Procedure: enzyme inhibitor therapy Procedure: growth factor antagonist therapy | Phase II |
MedlinePlus related topics: Eye Cancer; Melanoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Suberoylanilide Hydroxamic Acid in Patients with Metastatic Or Unresectable Melanoma
OBJECTIVES: Primary
- Determine the objective response rate in patients with metastatic or unresectable melanoma treated with suberoylanilide hydroxamic acid.
Secondary
- Determine time to progression in patients treated with this drug.
- Determine the utility of HIRA 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 suberoylanilide hydroxamic acid twice daily on days 1-14. Courses repeat every 21 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
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 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
Location and Contact Information
Naomi S. Balzer-Haas, MD, Principal Investigator, Fox Chase Cancer Center
More Information
Clinical trial summary from the National Cancer Institute''''s PDQ® database
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 20, 2005
ClinicalTrials.gov Identifier: NCT00121225
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26
Resources
- "Hidden" Melanomas (American Academy of Dermatology)
- ABCDs of Melanoma Detection (American Academy of Dermatology)

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