Status:
WITHDRAWN
Evaluation of Interferon-Lovastatin Therapy for Malignant Melanoma
Lead Sponsor:
NeoPlas Innovation
Conditions:
Melanoma
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Malignant melanoma, or simply melanoma, is a potentially fatal cancer which begins as a skin cancer and can spread very aggressively. The incidence of melanoma has been rising rapidly over the last de...
Eligibility Criteria
Inclusion
- (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
- (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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00963664
Start Date
December 1 2009
End Date
December 1 2016
Last Update
September 9 2009
Active Locations (1)
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1
NeoPlas Innovation
Nashville, Tennessee, United States, 37027