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Interferon Gamma-1b for Mycosis Fungoides and Sezary Syndrome
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.
- 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 belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You must wait at least 2 weeks until any side effects from a previous medical procedure or medication have completely resolved.You have stopped taking medications such as retinoids, interferons, vorinostat, romidepsin and denileukin diftitox for at least 2 weeks before starting the trial.You have received a stem cell transplant from a donor.You have an autoimmune disease that has needed treatment within the past 2 years.You have a medical condition that is not under control.You are pregnant or currently breastfeeding.You are pregnant or breastfeeding.You have mycosis fungoides or Sezary syndrome and are in treatment group I.You have received local radiation therapy at least two weeks before the start of the trial.You have received low-dose Total Skin Electron Beam Therapy (TSEBT) at least 8 weeks ago.Your blood and organs are working properly.You have taken a new or experimental treatment or used a new medical device in the last 4 weeks.You haven't received certain types of cancer treatments for at least 4 weeks (or 16 weeks in the case of alemtuzumab).You have received drugs that target T-cell co-stimulation or checkpoint pathways, such as ipilimumab, at least 15 weeks ago.You have a severe infection that needs to be treated with antibiotics given into your vein (intravenous antibiotics).If you have taken high doses of corticosteroids, you must stop taking them for at least four weeks before enrolling in the trial. However, if you take low or moderate doses, you can participate if you have been on the same dose for at least four weeks before enrollment. You can still use inhaled or topical corticosteroids, and any injections of corticosteroids must be reported.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.You have undergone phototherapy for at least two weeks.You agree to use a reliable form of birth control for 120 days after the last dose of study medication.You have already received chemotherapy treatment in the past.Your condition cannot be treated locally to completely cure it.You have received a monoclonal antibody treatment within the last 4 weeks or have not completely recovered from side effects caused by a treatment taken more than 4 weeks ago.You can't have received any cancer treatment, whether approved or experimental, within 14 days before starting the study.You are currently receiving treatment for cancer other than sarcoma.
- Group 1: Group II (pembrolizumab, interferon gamma-1b)
- Group 2: Group I (pembrolizumab, interferon gamma-1b)
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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