A Pilot Study of Pivanex in Patients With Malignant Melanoma

• Status: Terminated
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Titan Pharmaceuticals
• Treatments: Histone Deacetylase Inhibitors

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.