Evaluation of Interferon-Lovastatin Therapy for Malignant Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00963664
Recruitment Status : Withdrawn (Modifications will be necessary before full IRB approval will be secured.)
First Posted : August 21, 2009
Last Update Posted : September 9, 2009
Information provided by:
NeoPlas Innovation

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.

Condition or disease Intervention/treatment Phase
Melanoma Malignant Melanoma Drug: lovastatin Drug: interferon alfa-2b Phase 2

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 decade and it is now becoming a serious health threat in young adults as well as older adults. Unfortunately, if melanoma escapes complete surgical removal, there are very few treatments which have been found very effective in controlling its growth and spread. If the cancer spreads to the lymph node system or beyond, the chances for long-term survival can be very poor.

This study proposes to test the effectiveness for melanoma treatment of a combination of two medicines which are in widespread use for other medical conditions. Interferon alfa-2b (also known simply as interferon or by a brand name Intron-A) is an exact replica of a protein produced by the human immune system. The human body makes this immune system regulator to help it kill cells in the body which are damaged or infected and thus need to be removed before they can cause further harm to the body. This medicine is often prescribed for infections like hepatitis, some types of cancer including melanoma, and immune system disorders. This study uses interferon in moderate doses, much less than typically used for melanoma treatment when it is used alone, and so the side effects of treatment may be milder. The other medicine being used in combination with it is lovastatin. This medicine is most often used to help patients reduce their cholesterol levels and therefore reduce the risk of heart attacks and strokes. Millions of people use this medicine because it has been found very safe and effective. Research has shown that it also has significant effects against the growth of cancer cells in laboratory cultures and in some animal models.

These two medicines have been used together to treat patients with cancer for several years in our medical practice, but until now they have not been formally tested in a clinical trial. This study will test how well the combination of these medicines can perform and test the hypothesis that they can achieve better survival and control of disease than currently available standard treatment. The incidence of side effects and other details will be monitored too.

This study is open to qualifying patients with stage 2, 3, or 4 melanoma. The results for patients in each group will be compared to other patients in the study with the same or similar stage of disease and with historical results of patients receiving the standard, already-approved treatments for similar stages of melanoma.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Interferon Alfa-2b and Lovastatin Combination Therapy for Patients With High-risk Resected or Unresectable Malignant Melanoma
Study Start Date : December 2009
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Interferon and lovastatin treatment
Patients receive outpatient treatment with lovastatin (oral) and interferon alfa-2b (subcutaneous injection) as per protocol parameters.
Drug: lovastatin
lovastatin tablets, oral administration, daily dose 1.5 mg/kg, divided into three or four essentially equal doses with meals
Other Name: Mevacor

Drug: interferon alfa-2b
interferon alfa-2b for subcutaneous injection, each injection 100,000 international units per kg body mass, three injections weekly
Other Name: Intron-A

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 6 months, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr ]
  2. Time to progression of disease [ Time Frame: 2 mos, 4 mos, 6 mos, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr ]

Secondary Outcome Measures :
  1. Appearance of new distant metastases [ Time Frame: 2 mos, 4 mos, 6 mos, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr ]
  2. Toleration of medication side effects and quality of life [ Time Frame: 4 mos, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00963664

United States, Tennessee
NeoPlas Innovation
Nashville, Tennessee, United States, 37027
Sponsors and Collaborators
NeoPlas Innovation
Principal Investigator: Stephen B. Cantrell, MD NeoPlas Innovation

Responsible Party: Stephen B. Cantrell MD, Director of Research, NeoPlas Innovation Identifier: NCT00963664     History of Changes
Other Study ID Numbers: NI-MM-009
First Posted: August 21, 2009    Key Record Dates
Last Update Posted: September 9, 2009
Last Verified: September 2009

Keywords provided by NeoPlas Innovation:
malignant melanoma
interferon alfa-2b
Intron A

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
L 647318
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors