Clinical trial · Interventional
Evaluation of Interferon-Lovastatin Therapy for Malignant Melanoma
Phase 2 Study of Interferon Alfa-2b and Lovastatin Combination Therapy for Patients With High-risk Resected or Unresectable Malignant Melanoma
NCT00963664CI-TRIAL-00002609withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Modifications will be necessary before full IRB approval will be secured.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| interferon alfa-2b | Drug | Interferon Alfa-2b | ALIAS |
| lovastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Interferon and lovastatin treatment
- description
- Patients receive outpatient treatment with lovastatin (oral) and interferon alfa-2b (subcutaneous injection) as per protocol parameters.
- interventionNames
- Drug: lovastatin
- Drug: interferon alfa-2b
Primary outcomes (2)
- measure
- Overall survival
- timeFrame
- 6 months, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr
- measure
- Time to progression of disease
- timeFrame
- 2 mos, 4 mos, 6 mos, 1 yr, 2 yr, 3 yr, 4 yr, 5 yr
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.