Study on Polarized Dendritic Cell Therapy with Interferon Alpha-2, Rintatolimod, and Celecoxib for Treating HLA-A2+ Melanoma That Hasn't Responded to Treatment

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04093323

Provider View

This clinical trial is testing a new combination of treatments, including polarized dendritic cell therapy, interferon alpha-2, rintatolimod, and celecoxib, to see if they can help control melanoma in patients whose cancer has not responded to previous treatments.

Patient Parameters

Program Overview

This study is exploring a new treatment approach for patients with melanoma that has not responded to previous therapies. The treatment combines polarized dendritic cell therapy, which uses special white blood cells to boost the immune system, with interferon alpha-2, a drug that can slow cancer growth, rintatolimod, which may stimulate the immune system, and celecoxib, a pain reliever. The goal is to see if this combination can stop the cancer from growing or spreading.

Description

The main goal of this study is to see how well the combination of polarized dendritic cell therapy, interferon alpha-2, rintatolimod, and celecoxib works in treating melanoma that hasn't responded to other treatments. Researchers want to find out if this combination can help shrink tumors or stop them from growing.

Secondary goals include evaluating how long the treatment effects last and whether it can improve survival rates compared to other treatments. The study will also look at how the treatment affects the immune system and overall health.

Participants will receive interferon alpha-2 and rintatolimod through an IV, and celecoxib as a pill, for three days. Starting from the second cycle, they will also receive dendritic cell therapy through a small injection into the skin. This treatment cycle will repeat every three weeks for up to four cycles, as long as the cancer does not progress or cause severe side effects. After 12 weeks, patients whose cancer has not improved may switch to other treatments.

After finishing the study treatment, participants will have follow-up visits every three months for up to two years to monitor their health and any changes in their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must have a specific genetic marker called HLA-A2+.
  • Have melanoma that has not responded to previous treatments, including PD-1 or PD-L1 inhibitors.
  • Have at least one tumor that can be biopsied and is not the main tumor being measured for response.
  • Have measurable cancer according to standard criteria.
  • Be in good overall health with an ECOG performance status of 0 to 2.
  • Have adequate blood cell counts and organ function, including:
    • Platelet count of at least 75,000/microliter.
    • Hemoglobin level of at least 9 g/dL.
    • Neutrophil count of at least 1500/microliter.
    • Normal kidney and liver function within specified limits.
  • Women of childbearing potential must agree to use effective contraception during the study.
  • Understand the study and agree to sign informed consent.
  • Be eligible to continue or resume PD-1/PD-L1 inhibitor treatment alongside the study therapy.

Exclusion Criteria

  • Currently taking immunosuppressive medications, including steroids, unless for hormone replacement.
  • Have had cancer treatment within two weeks before starting the study or have not recovered from side effects of previous treatments.
  • Have another active cancer that requires treatment.
  • Have active brain metastases or cancer in the brain lining, unless stable for more than four weeks.
  • Have had recent serious heart problems or have severe heart disease.
  • Have an active infection requiring treatment.
  • Have active hepatitis B or C infection.
  • Have an immune system disorder like HIV/AIDS.
  • Have allergies to study drugs or similar medications.
  • Have received a blood transfusion within two weeks before starting the study.
  • Women who are pregnant or breastfeeding.
  • Unable or unwilling to follow study requirements.
  • Any condition that makes participation unsafe according to the study doctor.
  • Developed resistance to PD-1/PD-L1 inhibitors after initially responding.

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