Recombinant Interferon Alfa-2b for Melanoma

1
Effectiveness
2
Safety
Aurora Cancer Care-Waukesha, Waukesha, WI
Melanoma+6 More
Recombinant Interferon Alfa-2b - Biological
Eligibility
18+
All Sexes
Eligible conditions
Melanoma

Study Summary

This study is evaluating whether ipilimumab with or without high-dose recombinant interferon alfa-2b works better than ipilimumab alone in treating patients with stage III-IV melanoma that cannot be removed by surgery.

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Eligible Conditions

  • Melanoma
  • Cancer of Skin
  • Recurrent Melanoma
  • Stage IV Cutaneous Melanoma AJCC v6 and v7
  • Skin Neoplasms
  • Stage IIIB Cutaneous Melanoma AJCC v7
  • Stage IIIC Cutaneous Melanoma AJCC v7
  • Stage IIIA Cutaneous Melanoma AJCC v7

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Recombinant Interferon Alfa-2b will improve 1 primary outcome, 3 secondary outcomes, and 2 other outcomes in patients with Melanoma. Measurement will happen over the course of Assessed every 12 weeks for 3 years.

Year 3
Clinical Response Rate
Immune-related Response Rate Per Immune-related Response Criteria
Year 10
Overall Survival
Overall Survival (OS)
Progression-free Survival
Progression-free Survival (PFS)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

4 Treatment Groups

No Control Group
Arm A (higher dose ipilimumab, HDI)

This trial requires 88 total participants across 4 different treatment groups

This trial involves 4 different treatments. Recombinant Interferon Alfa-2b is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm A (higher dose ipilimumab, HDI)INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks. MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.
Arm B (higher dose ipilimumab)INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses. MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.
Arm C (lower dose ipilimumab + HDI)INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks. MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks.
Arm D (lower dose ipilimumab)INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses. MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Interferon alfa-2b
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessed every 3 months for two years, then every 6 months for 3 years, then every 12 months for up to 10 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly assessed every 3 months for two years, then every 6 months for 3 years, then every 12 months for up to 10 years for reporting.

Closest Location

Aurora Cancer Care-Waukesha - Waukesha, WI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Melanoma or one of the other 6 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients with prior history at any time of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ are eligible
Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (e.g., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional (but not continuous) use of steroid inhalers is allowed; replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of these classes of medication for at least 2 weeks prior to randomization are eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study; exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjogren's syndrome, autoimmune vasculitis [e.g., Wegener's granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia gravis); other central nervous system (CNS) autoimmune disease (e.g., poliomyelitis, multiple sclerosis); patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible
Amenorrhea >= 24 consecutive months without another cause, or For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level >= 35 mIU/mL Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential; men of fathering potential and WOCBP must be using an adequate method of contraception or must abstain from sexual intercourse to avoid conception/pregnancy throughout the study and for up to 26 weeks after the last dose of ipilimumab or HDI in such a manner that the risk of pregnancy is minimized; men or WOCBP who are unwilling or unable to strictly follow this requirement are not eligible
Patients must have unresectable stage III or stage IV melanoma, either initial presentation or recurrent, that is of cutaneous origin or unknown primary origin and that is histologically diagnosed
Patients with prior history of basal or squamous skin cancer are eligible
No more than one prior systemic therapeutic regimen for unresectable stage III or stage IV melanoma; this includes chemotherapy, biologic therapy, biochemotherapy, or investigational treatment; this does not include any therapies given in the adjuvant setting; however, patients are excluded if they have a history of prior treatment for melanoma (either adjuvant or metastatic disease) with ipilimumab or other cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitor, or prior interferon-alpha treatment for metastatic disease (history of adjuvant interferon-alpha is allowed); there should be a 4-week washout period between last treatment administration and initiation of study therapy
Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Patients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that in the opinion of the investigator may interfere with compliance, make the administration of ipilimumab or HDI hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea; patients must not have an active infection requiring current treatment with parenteral antibiotics
Patients must not have a history of inflammatory bowel disease or diverticulitis (history of diverticulosis is allowed)
Due to the possible effect of treatment with ipilimumab on the immunologic response to infectious disease vaccines, patients must not have had any infectious disease vaccination (e.g, standard influenza, H1N1 influenza, pneumococcal, meningococcal, tetanus toxoid) within 4 weeks prior to randomization

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of melanoma?

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Symptoms are usually nonspecific, and melanomas may present without symptoms. Melanomas involving the eyelid or nose can present with sudden onset of blindness or ophthalmoscopic lesions. Most melanomas are discovered by nonspecific skin lesions.

Unverified Answer

Can melanoma be cured?

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In the modern era, a substantial majority of melanomas will present with a curable stage. More than half will metastasize and die within five years, while 5% can become a primary or metastasis within one year. Melanoma's dismal prognosis is most likely due to its late clinical presentation, because of its tendency to metastasize and because it rarely develops effective therapy.

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What causes melanoma?

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Melanoma is not caused by a mutation in the melanocyte, but seems to arise from a malfunction of the DNA repair process. Melanopsin-expressing melanocytes have a selective advantage in the DNA damage response against ultraviolet irradiation, and in this way melanoma develops.

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What are common treatments for melanoma?

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As the prevalence of early detection for the most common cancers increases, more treatments (and even innovative approaches) targeting specific disease pathways (e.g., biological therapies) will be necessary for cancer patients to obtain more effective treatment.

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How many people get melanoma a year in the United States?

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More than 4 in 10,000 US adults are diagnosed with melanoma each year. Many are diagnosed prior to 80 years of age, when they are at the highest risk of melanoma development. In the United States, early skin examination as part of melanoma screening programmes is important, particularly in individuals of Ashkenazi Jewish background.

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What is melanoma?

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Melanoma is a type of skin cancer that contains malignant-appearing melanocytes of the skin. It typically appears on sun-exposed skin surfaces and on the areas of moles that have developed. It accounts for approximately 75% of all skin cancer cases.\n

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How quickly does melanoma spread?

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Different tumour types, differing metastatic patterns, and differing immune status all seem to influence the rate of metastasis of different types of cancer. In many people with cancer, the spread of cancer is a gradual process, particularly for cancers of the skin. For most people, metastasis does not happen instantly. The spread of melanoma in some people is different from what most experts presume: the melanoma is found in the lymph nodes before it begins to spread, and not, for example, to the lungs, as many melanoma experts suppose. One thing is for sure - metastasis is a gradual and irreversible process.

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Does recombinant interferon alfa-2b improve quality of life for those with melanoma?

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There were no clinically significant differences in QoL scores between the placebo and experimental arms in the short term for this large phase II trial of interferon alfa-2b in melanoma patients. Patients' perception of their QoLs improved regardless of treatment, suggesting that treatment of melanoma with interferon alfa-2b does not adversely affect QoL as measured at short intervals. Further investigation is needed into potential adverse effects of interferon alfa-2b on QoL, as well as the role of interferon alfa-2b in non-melanoma cancers.

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What does recombinant interferon alfa-2b usually treat?

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In routine clinical practice, IFN alfa-2b appears to be the most frequently used treatment for all genotypes and histology of patients diagnosed with metastatic melanoma.

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How does recombinant interferon alfa-2b work?

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The mechanism by which rhIFN-alpha-2b suppresses the growth of MCF-7 [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) cells in vitro and in nude mice is not by triggering antibody production against IFN-alpha, but by a direct action on cancer cells. This result suggests that the anti-tumor activity of rhIFN-alpha-2b is associated with the activation and maturation of innate immune system cells and subsequent release of IFN-alpha and IFN-gamma, leading to tumor cell destruction.

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Is recombinant interferon alfa-2b safe for people?

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There were no significant side effects in patients treated with a total of 1.6 (N=29) or 2.4 (N=7) million units weekly for 4 to 12 months. There appear to be differences in side effects between men and women, older people and younger people. There are also differences in side effects depending on people's baseline condition.

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What are the chances of developing melanoma?

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It appears that there is a genetically determined likelihood of contracting the diagnosis. But it is not a simple yes or no. Those who had dermatologists in their families are likely to develop skin cancer. There are also those who live in climates where skin cancers are more common, and those who have personal or family history of skin cancer. There are also those without any family history who developed melanoma. It seems that skin cancer is a family trait that can't be passed on from one generation to another. The reason why it appears to be a genetically determined trait, rather than a simple lifestyle-related one, is only speculative...

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