Evaluation of Interferon-Lovastatin Therapy for Malignant Melanoma

This study has been withdrawn prior to enrollment.
(Modifications will be necessary before full IRB approval will be secured.)
Sponsor:
Information provided by:
NeoPlas Innovation
ClinicalTrials.gov Identifier:
NCT00963664
First received: August 20, 2009
Last updated: September 4, 2009
Last verified: September 2009
  Purpose

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 Intervention Phase
Melanoma
Malignant Melanoma
Drug: lovastatin
Drug: interferon alfa-2b
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by NeoPlas Innovation:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 6 months, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr ] [ Designated as safety issue: No ]
  • Time to progression of disease [ Time Frame: 2 mos, 4 mos, 6 mos, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Appearance of new distant metastases [ Time Frame: 2 mos, 4 mos, 6 mos, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr ] [ Designated as safety issue: No ]
  • Toleration of medication side effects and quality of life [ Time Frame: 4 mos, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: December 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963664

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

No publications provided

Responsible Party: Stephen B. Cantrell MD, Director of Research, NeoPlas Innovation
ClinicalTrials.gov Identifier: NCT00963664     History of Changes
Other Study ID Numbers: NI-MM-009
Study First Received: August 20, 2009
Last Updated: September 4, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by NeoPlas Innovation:
melanoma
malignant melanoma
interferon
interferon alfa-2b
Intron-A
Intron A
Intron
lovastatin
mevinolin
Mevacor
mevacor
statin
HRI

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Reaferon
Lovastatin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Adjuvants, Immunologic
Alcohol Deterrents
Central Nervous System Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents

ClinicalTrials.gov processed this record on July 22, 2014