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Cytokine

Interferon Gamma-1b for Mycosis Fungoides and Sezary Syndrome

Phase 2
Waitlist Available
Led By Michael S Khodadoust, MD
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stage IB-IVB Mycosis Fungoides or Sezary syndrome, and who have relapsed, are refractory, or progressed after at least one standard systemic therapy; maximal stage since diagnosis will determine eligibility; current disease stage at time of entry will also be documented but will not be used for eligibility
>= 2 weeks for phototherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing pembrolizumab and interferon gamma-1b to see if they're effective in treating patients with mycosis fungoides or Sezary syndrome that has relapsed or is refractory.

Eligible Conditions
  • Mycosis Fungoides and Sezary Syndrome
  • Synovial Sarcoma
  • Cutaneous T-Cell Lymphoma
  • Round Cell Liposarcoma
  • Myxoid Liposarcoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have advanced stage Mycosis Fungoides or Sezary syndrome that has not responded to at least one standard treatment. The eligibility for the study will depend on the highest stage you have been diagnosed with.
Select...
You have undergone phototherapy for at least two weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Duration of Response (DOR)
Event-free Survival (EFS)
Incidence of Adverse Events
+3 more
Other outcome measures
Biomarkers in Tumor and Blood Assessed by Immunohistochemistry, Mass Spectrometry, Nanostring, Sequencing, and Enzyme-linked Immunosorbent Assay

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group II (pembrolizumab, interferon gamma-1b)Experimental Treatment3 Interventions
Patients pembrolizumab IV over 30 minutes on day 1 and interferon gamma-1b SC once a week. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity.
Group II: Group I (pembrolizumab, interferon gamma-1b)Experimental Treatment3 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity. Patients also receive interferon gamma-1b SC 3 times per week for 12 weeks, and then follow 3 weeks on and 3 weeks off schedule for up to 2 years in the absence of disease progression or unexpected toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Interferon gamma-1b
FDA approved
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,618 Total Patients Enrolled
Michael S Khodadoust, MDPrincipal InvestigatorCancer Immunotherapy Trials Network

Media Library

Interferon Gamma-1b (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT03063632 — Phase 2
Mycosis Fungoides and Sezary Syndrome Research Study Groups: Group II (pembrolizumab, interferon gamma-1b), Group I (pembrolizumab, interferon gamma-1b)
Mycosis Fungoides and Sezary Syndrome Clinical Trial 2023: Interferon Gamma-1b Highlights & Side Effects. Trial Name: NCT03063632 — Phase 2
Interferon Gamma-1b (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03063632 — Phase 2

Frequently Asked Questions

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

Are participants still being sought for this research project?

"This study is not presently open to new patients. The trial was initially posted on 10/13/2017 and was last edited on 8/2/2022. However, there are 1976 studies actively recruiting patients with mycosis fungoides and 1003 trials for Pembrolizumab that are currently searching for participants."

Answered by AI

Could you tell me how many research facilities are being used to manage this study?

"This clinical trial is being conducted by University of Miami Miller School of Medicine-Sylvester Cancer Center, Memorial Sloan Kettering Cancer Center, and University of Pennsylvania/Abramson Cancer Center. In addition, there are 7 other medical facilities participating in this study."

Answered by AI

What goals does this experiment hope to realize?

"The primary goal of this medical study, which will take place over the course of a year, is to measure the Overall Response Rate (ORR). Additionally, researchers will assess Progression-free survival (PFS) and Incidence of adverse events as secondary objectives. PFS will be determined using the Kaplan-Meier method while CTCAE version 5.0 will be used to grade adverse events."

Answered by AI

Are there any reports of serious adverse effects from taking Pembrolizumab?

"While there is some data supporting the safety of Pembrolizumab, it is still in Phase 2 of clinical trials and has not yet been proven effective. Therefore, it received a score of 2."

Answered by AI

Could you please list some other Pembrolizumab research projects?

"Pembrolizumab was first studied in 2010 at City of Hope. In the decade since, there have been 815 completed clinical trials and 1003 active studies. A large number of these latter studies are based out of Miami, Florida."

Answered by AI

Pembrolizumab is often administered for what reasons?

"Pembrolizumab can be used as treatment for various cancers including malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

How many participants will this research project be testing?

"Currently, this study is not seeking any new participants. However, this may change in the future as the study was most recently updated on 8/2/2022. There are 1976 other studies involving mycosis fungoides and 1003 trials for Pembrolizumab that are currently looking for patients."

Answered by AI
~4 spots leftby Mar 2025