Evaluation of Interferon-Lovastatin Therapy for Malignant Melanoma

September 4, 2009 updated by: NeoPlas Innovation

Phase 2 Study of Interferon Alfa-2b and Lovastatin Combination Therapy for Patients With High-risk Resected or Unresectable Malignant Melanoma

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

250

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37027
        • NeoPlas Innovation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Intron-A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 6 months, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr
6 months, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr
Time to progression of disease
Time Frame: 2 mos, 4 mos, 6 mos, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr
2 mos, 4 mos, 6 mos, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeoPlas Innovation

Investigators

  • Principal Investigator: Stephen B. Cantrell, MD, NeoPlas Innovation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

August 20, 2009

First Submitted That Met QC Criteria

August 20, 2009

First Posted (ESTIMATE)

August 21, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 9, 2009

Last Update Submitted That Met QC Criteria

September 4, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI-MM-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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