A Pilot Study of Pivanex, a Histone Deacetylase Inhibitor, in Patients With Malignant Melanoma
Data Collection
Melanoma+8
+ Neoplasms
+ Neoplasms by Histologic Type
Treatment Study
Summary
Study start date: January 1, 2004
Actual date on which the first participant was enrolled.Rationale: Pivanex is a histone deacetylase inhibitor that induces tumor differentiation, inhibits proliferation, and induces apoptosis. Pivanex has been generally well tolerated in clinical trials and has shown preliminary evidence of efficacy in patients with non-small cell lung cancer. Pivanex has shown in-vitro and in-vivo evidence of anti-tumor activity against melanoma and, therefore, represents a promising therapeutic approach to patients with malignant melanoma. Purpose: This open-label trial will determine the response rate of Pivanex in patients with malignant melanoma. Objectives: * Determine time to disease progression * Determine overall survival * Determine the safety profile of Pivanex in malignant melanoma Outline: This is an open-label, single center study in patients with malignant melanoma whose disease has progressed or failed to respond to chemotherapy or Interleukin-2 (IL-2). Patients will be treated with 2.5 g/m2 of Pivanex administered intravenously over 6 hours daily on Days 1 - 3. Treatment will be repeated every 21 days until tumor progression or the patient is withdrawn from treatment for other protocol-specified reasons. Tumor status will be assessed prior to every odd-numbered treatment cycle using the Response Evaluation Criteria in Solid Tumors (RECIST) method. Patients who continue to experience tumor response or stabilization at the time treatment is discontinued will be followed every 12 weeks for tumor status until disease progression.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.14 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Histologically or cytologically confirmed melanoma, previously treated with chemotherapy or IL-2 * Recurrent or progressive disease after treatment. * Measurable disease. * Males and females, age ≥ 18 years. * Adequate renal function with creatinine ≥ 1.5 mg/dl. * Adequate liver function with alkaline phosphatase \<= 2.5 X upper limit of normal, SGOT and SGPT \<= 1.5 X upper limit of normal and total bilirubin \<= 1.5 X upper limit of normal. * Adequate bone marrow function: platelets ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL, and absolute neutrophil count (ANC)≥ 1,500 cells/mm3. * Able to give informed consent. * Must have discontinued previous surgery, radiation therapy or cancer chemotherapy at least four weeks prior to randomization (six weeks if a prior nitrosourea or mitomycin C), with recovery from treatment-associated toxicity. Localized palliative radiation therapy to non-target lesions is permitted within the four weeks prior to randomization. * A predicted life expectancy of at least 6 months. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: * Receipt of more than three (3) systemic treatment regimens for malignant melanoma (including IL-2). * A second malignancy within the last 5 years other than curatively treated carcinoma-in-situ or non-melanoma skin cancer. * Pregnant or lactating females. Females of childbearing potential must have a negative pregnancy test and all male and female patients of reproductive potential must agree to use adequate birth control. * Known HIV-positive patients. * Acute medical problems, such as ischemic heart or lung disease or uncontrolled systemic infection. * Patients with any underlying medical conditions or circumstance, which would contraindicate therapy with study treatment, affect compliance or impair evaluation of study endpoints. * Patients receiving investigational agents within 4 weeks of randomization. * Known allergy to reagents in the study. * Symptomatic or untreated brain metastases - Patients with brain metastases are eligible if they are clinically and neurologically stable for ≥ 4 weeks since therapy (radiation therapy, radiosurgery/gamma knife, surgical resection) as determined by the investigator and either off corticosteroids or on a stable dose of corticosteroids.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location