Status:
TERMINATED
A Pilot Study of Pivanex in Patients With Malignant Melanoma
Lead Sponsor:
Titan Pharmaceuticals
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 inv...
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 an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2004
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00087477
Start Date
January 1 2004
End Date
August 1 2004
Last Update
August 30 2005
Active Locations (1)
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1
Mt. Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140