Evaluation of Interferon-Lovastatin Therapy for Malignant Melanoma

NCT00963664 | Withdrawn Phase 2

• 1 other identifier: NI-MM-009
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma; Malignant Melanoma

Keywords

melanoma; malignant melanoma; interferon; interferon alfa-2b; Intron-A; Intron A; Intron; lovastatin; mevinolin; Mevacor; statin; HRI

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (1)

Interferon and lovastatin treatment

EXPERIMENTAL

Patients receive outpatient treatment with lovastatin (oral) and interferon alfa-2b (subcutaneous injection) as per protocol parameters.

Drug: lovastatin; Drug: interferon alfa-2b

Interventions

lovastatin DRUG

lovastatin tablets, oral administration, daily dose 1.5 mg/kg, divided into three or four essentially equal doses with meals

Also known as: Mevacor

Interferon and lovastatin treatment

interferon alfa-2b DRUG

interferon alfa-2b for subcutaneous injection, each injection 100,000 international units per kg body mass, three injections weekly

Also known as: Intron-A

Interferon and lovastatin treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NeoPlas Innovation: lead

Study Sites (1)

NeoPlas Innovation

Nashville, Tennessee, 37027, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Lovastatin; Interferon alpha-2; Introns

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes

Study Officials

• Stephen B. Cantrell, MD

  NeoPlas Innovation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 20, 2009
• First Posted: August 21, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 9, 2009

Record last verified: 2009-09

Locations

US (1)