Suspended

A Pilot Study of Pivanex, a Histone Deacetylase Inhibitor, in Patients With Malignant Melanoma

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Melanoma+8

+ Neoplasms

+ Neoplasms by Histologic Type

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: January 2004
See protocol details

Summary

Principal SponsorTitan Pharmaceuticals
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

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 Treatment will be repeated every 21 days until tumor progression or the patient is withdrawn from treatment for other protocol-specified reasons.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.

Official TitleA Pilot Study of Pivanex, a Histone Deacetylase Inhibitor, in Patients With Malignant Melanoma 
Principal SponsorTitan Pharmaceuticals
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

14 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

MelanomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueSkin DiseasesSkin NeoplasmsNeuroectodermal TumorsNevi and MelanomasNeuroendocrine Tumors

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

Suspended

Mt. Sinai Comprehensive Cancer Center

Miami Beach, United StatesSee the location
SuspendedOne Study Center