High-Dose Interferon Alfa for Melanoma

Not currently recruiting at 537 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: ECOG-ACRIN Cancer Research Group

Must not be taking: Chemotherapy, Immunotherapy, Corticosteroids, others

Disqualifiers: Metastatic disease, Autoimmune disorders, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 23

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if high-dose interferon alfa is more effective than observation alone for treating stage II or III melanoma that has been completely removed by surgery. Interferon alfa may help stop cancer cells from growing. Participants will either receive interferon alfa treatment or be observed without treatment for comparison. The trial seeks individuals who have had melanoma surgically removed and meet specific criteria, such as having certain types of melanoma and no other cancer history in the past five years. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as systemic corticosteroids (like prednisone) and other immunosuppressive drugs, before participating. If you are on these medications, you will need to discuss with your doctor about stopping them.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that high-dose interferon alfa-2b is usually well-tolerated, though it can cause mild side effects. One study found that about 7.5% of patients experienced mild kidney problems. While some individuals did have side effects, they were not severe. Another study found that the treatment can extend life and reduce cancer recurrence, but reactions vary among individuals. Interferon alfa-2b is already used to treat melanoma, indicating that its safety is fairly well understood. However, experiences can differ, so discussing potential risks with a healthcare provider is advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about high-dose interferon alfa-2b for melanoma because it offers a unique approach by using a high concentration of the active ingredient, interferon alfa-2b, which is delivered intravenously. This method allows for a more direct and concentrated attack on melanoma cells compared to standard treatments, which often involve surgery or chemotherapy. Interferon alfa-2b works by boosting the body's immune response to better target and destroy cancer cells, potentially leading to improved outcomes for patients. Additionally, this treatment is administered over a condensed period, which may result in quicker effects compared to traditional therapies.

What evidence suggests that high-dose interferon alfa might be an effective treatment for melanoma?

Studies have shown that high-dose interferon alfa-2b can help delay the return of melanoma, a type of skin cancer. In this trial, some participants will receive high-dose interferon alfa-2b, which research indicates reduces the chance of cancer recurrence when used after surgery. Specifically, it helped patients remain melanoma-free for longer and increased their overall survival. It was the first treatment to demonstrate these benefits for patients at high risk of melanoma returning after surgery. Therefore, interferon alfa-2b has a proven track record of benefiting people at high risk of cancer recurrence. ^{2 4 6 7 8}

Who Is on the Research Team?

Alberto S. Pappo, MD

Principal Investigator

Texas Children's Cancer Center

William E. Carson, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Michael Smylie, MD, MB, ChB

Principal Investigator

Cross Cancer Institute at University of Alberta

Sanjiv S. Agarwala, MD

Principal Investigator

St. Luke's Cancer Network at St. Luke's Hospital

John M. Kirkwood, MD

Principal Investigator

UPMC Cancer Center at UPMC Presbyterian

Lawrence E. Flaherty, MD

Principal Investigator

Barbara Ann Karmanos Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with stage II or III melanoma that's been surgically removed. They must have good organ function, no other cancers in the past 5 years, and not be pregnant or nursing. Participants need to use effective contraception and can't have autoimmune disorders, heart failure, a history of stroke or ischemic heart disease, cognitive impairments, or be on immunosuppressive treatments.

Inclusion Criteria

My skin cancer is at Stage II with a thickness of 1.5-4.0 mm.

My skin cancer is confirmed as melanoma.

My lymph nodes do not show signs of cancer, either by clinical exam or biopsy.

Exclusion Criteria

Clinical, radiological/laboratory, or pathological evidence of incompletely resected melanoma or any distant metastatic disease; Clinically palpable lymphadenopathy; Evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that would preclude study participation; Other significant medical or surgical condition, or any medication or treatment regimens, that would interfere with study participation; Pregnant or nursing; Other history of invasive melanoma; Autoimmune disorders or conditions of immunosuppression; History of active ischemic heart disease; Cerebrovascular disease; Congestive heart failure (New York Heart Association class III or IV heart disease); Prior or concurrent chemotherapy; Prior immunotherapy including tumor vaccines, interferon, interleukins, levamisole, or other biologic response modifiers for melanoma; Concurrent systemic corticosteroids including oral steroids (i.e., prednisone, dexamethasone), topical steroid creams or ointments, or any steroid-containing inhalers; Prior or concurrent radiotherapy; Other concurrent immunosuppressive medications

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high-dose interferon alfa-2b intravenously for 5 consecutive days weekly for 4 weeks

4 weeks

20 visits (in-person)

Observation

Participants undergo observation for 4 weeks

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 years

Every 3 months for 2 years, every 6 months for 3 years, then annually

What Are the Treatments Tested in This Trial?

Interventions

• Interferon alfa-2b

Trial Overview The study is testing high-dose interferon alfa against just observation to see which is better at preventing cancer growth after surgery. Patients are randomly assigned to either get the drug treatment or undergo regular monitoring without additional therapy.

How Is the Trial Designed?

Group I: Observation Experimental Treatment 1 Intervention

Patients undergo observation for 4 weeks.

Group II: Interferon Alfa-2b Experimental Treatment 1 Intervention

Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

Southwest Oncology Group

Collaborator

Trials

389

Recruited

260,000+

SWOG Cancer Research Network

Collaborator

Trials

403

Recruited

267,000+

NCIC Clinical Trials Group

Collaborator

Trials

190

Recruited

145,000+

Cancer and Leukemia Group B

Collaborator

Trials

81

Recruited

118,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Children's Oncology Group

Collaborator

Trials

467

Recruited

241,000+

Published Research Related to This Trial

High-dose adjuvant interferon alpha-2b (IFN alpha 2b) improves quality-adjusted survival (QAS) for melanoma patients, with 77% of patients in one trial experiencing a benefit, although this was not statistically significant for all.

The effectiveness of IFN alpha 2b on QAS is influenced more by patients' perceptions of its toxicity rather than the fear of melanoma recurrence, indicating that cancer patients may have a higher tolerance for treatment side effects compared to the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality-of-life-adjusted survival analysis of high-dose adjuvant interferon alpha-2b for high-risk melanoma patients using intergroup clinical trial data. Kilbridge, KL., Cole, BF., Kirkwood, JM., et al.[2018]

High-dose interferon-alpha2b is an FDA-approved treatment for stage III melanoma, but its limited effectiveness and significant side effects make it a controversial choice among patients and doctors.

This paper aims to assess the benefits and risks of high-dose interferon-alpha2b, providing a framework to help oncologists support patients in making informed treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helping melanoma patients decide whether to choose adjuvant high-dose interferon-alpha2b. Hurley, KE., Chapman, PB.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4207058/

Adjuvant High-Dose Interferon for Cutaneous Melanoma is ... At 5 years, the use of IFN was associated with lower rates of disease recurrence, with a cumulative absolute benefit of 9%. However, these results did not ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11331315/

High-dose interferon alfa-2b significantly prolongs relapse ... This trial demonstrated a significant treatment benefit of HDI versus GMK in terms of RFS and OS in melanoma patients at high risk of recurrence.

3. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.22.02264

Interferon Alfa-2b Adjuvant Therapy of High-Risk Resected ... IFN alpha-2b is the first agent to show a significant benefit in relapse-free and overall survival of high-risk melanoma patients in a randomized controlled ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00749684

Efficacy and Safety of High-dose Interferon Alfa-2b (Intron ... The aim of this observational study is to document the efficacy and tolerability of high-dose interferon therapy in adult participants with malignant melanoma ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0959804998000021

Cost-effectiveness assessment of interferon alfa-2b as ... The use of interferon alfa-2b (IFN-α2b) as adjuvant therapy of high-risk resected cutaneous melanoma was recently found to significantly improve ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9122729/

Efficacy, Safety, and Risk-Benefit Analysis of Adjuvant ... Adjuvant rIFN-alpha 2b increased the median overall survival to 3.82 years in the treatment group compared with 2.78 years with observation and yielded a 5-year ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10882328/

Adjuvant high-dose interferon alfa-2b in patients with ... Three patients (7.5%) experienced mild renal toxicity. At a median follow-up of 27 months from initiation of therapy, there have been 19 relapses (47.5% disease ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1359610114001622

The use of interferon in melanoma patients: A systematic ... The use of IFN in patients with metastatic melanoma is controversial, with limited data and no convincing evidence of a survival benefit. However, IFN therapy ...