A Pilot Study of Pivanex in Patients With Malignant Melanoma - Full Text View

Sponsored by:	Titan Pharmaceuticals
Information provided by:	Titan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00087477

Purpose

This pilot study will assess the safety and efficacy of Pivanex alone in patients with malignant melanoma who have relapsed after treatment with chemotherapy or Interleukin-2 (IL-2). Pivanex is an investigational agent.

Condition	Intervention	Phase
Malignant Melanoma	Drug: Pivanex	Phase I Phase II

MedlinePlus related topics: Melanoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Pilot Study of Pivanex, a Histone Deacetylase Inhibitor, in Patients With Malignant Melanoma

Further study details as provided by Titan Pharmaceuticals:

Estimated Enrollment:	14
Study Start Date:	January 2004
Estimated Study Completion Date:	August 2004

Detailed Description:

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Treatment will be repeated every 21 days until tumor progression or the patient is withdrawn from treatment for other protocol-specified reasons.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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087477

Locations

United States, Florida
Mt. Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140

Sponsors and Collaborators

Titan Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	PIV-800
Study First Received:	July 8, 2004
Last Updated:	August 26, 2005
ClinicalTrials.gov Identifier:	NCT00087477 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Titan Pharmaceuticals:

Malignant Melanoma, Pivanex, Histone deacetylases inhibitor

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on May 07, 2009