Evaluation of Interferon-Lovastatin Therapy for Malignant Melanoma

Sponsor

NeoPlas Innovation (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00963664

Collaborator

(none)

250

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

N/A

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 :

Dec 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Overall survival [6 months, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr]
Time to progression of disease [2 mos, 4 mos, 6 mos, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr]

Secondary Outcome Measures

Appearance of new distant metastases [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 [4 mos, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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