A Pilot Study of Pivanex in Patients With Malignant Melanoma

NCT00087477 | Terminated Phase 1

• 1 other identifier: PIV-800
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Melanoma

Keywords

Malignant Melanoma, Pivanex, Histone deacetylases inhibitor

Interventions

Pivanex DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Titan Pharmaceuticals: lead

Study Sites (1)

Mt. Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

pivalyloxymethyl butyrate

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 8, 2004
• First Posted: July 13, 2004
• Study Start: January 1, 2004
• Study Completion: August 1, 2004
• Last Updated: August 30, 2005

Record last verified: 2005-08

Locations

US (1)