Evaluation of Interferon-Lovastatin Therapy for Malignant Melanoma

• Status: Withdrawn
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether an outpatient combination of lovastatin and low-to-moderate dose interferon is effective in the treatment of patients with malignant melanoma.

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

Details

• Lead Sponsor: NeoPlas Innovation
• Treatments: Dihydromevinolin; Interferon alpha-2; Interferon-alpha; Interferons; L 647318; Lovastatin

Criteria

Inclusion Criteria: (patients must meet all these criteria)

• Histologically confirmed diagnosis of malignant melanoma

• AJCC stage 2, 3, or 4 disease subject to the planned patient enrollment numbers for this trial

• Surgical resection to the extent possible

• ECOG performance status of 0, 1, or 2

• Expected survival of six months or greater

• ALT (SGPT) and AST (SGOT) not greater than 2.5x upper limit of normal range

• CT, PET or other valid imaging sufficient to demonstrate extent of disease performed less than three weeks prior to initiation or less than two weeks following initiation

• Female patients of childbearing potential must agree to practice contraception, abstinence, or other effective pregnancy avoidance measures while enrolled in this trial and for one month afterward

Exclusion Criteria: (patients meeting any of these criteria are ineligible)

• Current or anticipated pregnancy or breastfeeding

• History of or evidence suggestive of cerebral metastatic disease

• Impaired ability to absorb nutrition and/or medications normally via gastrointestinal tract

• Less than 18 years of age

• History or evidence of cirrhosis, chronic hepatitis, pancreatitis, or other significant hepatobiliary impairment

• History or evidence of HIV infection or other immune system impairment

• History of organ or tissue transplant requiring immunosuppressive therapy

• History of neutropenia other than that induced by chemotherapy

• Cytotoxic chemotherapy or radiation treatment within three weeks prior to initiation

• Presence of greater than six identifiable tumors counting all primary and metastatic lesions

• Presence of any single tumor mass greater than 6 cm in greatest dimension

• Presence of three or more tumor masses greater than 4 cm in greatest dimension

• Chronic steroid or immunosuppressive therapy

• Any other serious medical condition which, in the medical opinion of the investigator, limits life expectancy to two years or less or has significant potential for debilitation

• Any condition, psychiatric or otherwise, which may preclude valid informed consent or consistent compliance with study requirements in the medical opinion of the investigator