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Clinical Trial Name - Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma
| Original Study ID : CDR0000436851 |
| Secondary ID : Array |
| NCT ID : NCT00121225 |
| Brief Title : Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma |
| Official Title : A Phase II Study of Suberoylanilide Hydroxamic Acid (SAHA) in Advanced Melanoma |
| Brief 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. |
| Source : National Cancer Institute (NCI) |
| 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. |
| Overall Status : Active, not recruiting |
| Start Date : September 2005 |
| Official Title : Phase 2 |
| Phase : Interventional |
| Study Design : Treatment, Open Label |
| Enrollment : 32 |
| Verification Date : December 2008 |
| First Received Date : July 19, 2005 |
| Trial 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 |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Abramson Cancer Center of the University of Pennsylvania |
| City : Philadelphia |
| State : Pennsylvania |
| Zip Code : 19104-4283 |
| Country : United States |
| Facility Name : Margaret and Charles Juravinski Cancer Centre |
| City : Hamilton |
| State : Ontario |
| Zip Code : L8V 5C2 |
| Country : Canada |
| Facility Name : Princess Margaret Hospital |
| City : Toronto |
| State : Ontario |
| Zip Code : M5G 2M9 |
| Country : Canada |
| OutComes |
| Primary OutComes |
| Measure : Objective response rate using measurable disease as measured by RECIST criteria |
| Safety issue : No |
| Secondary OutComes |
| Measure : Time to progression |
| Safety issue : No |
| Measure : Progression-free survival at 2 months |
| Safety issue : No |
| Measure : Effect of vorinostat on HP1 and macro H2A nuclear foci |
| Safety issue : No |
| Measure : Effect of vorinostat on vascular endothelial growth factor and basic fibroblast growth factor |
| Safety issue : No |
| Measure : Correlation of WT, 72R, and 72P p53 alleles with response |
| Safety issue : No |
| Interventions |
| Type : Drug |
| Name : vorinostat |
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