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Alkylating agents
Genetically Engineered T Cells + Chemotherapy for Ovarian Cancer
Phase 1
Waitlist Available
Led By Emese Zsiros, MD
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights
Summary
This trial is testing T cells that have been genetically engineered to target and kill cancer cells, given after a chemotherapy regimen designed to make room in the bone marrow for new blood cells. The hope is that this will replace the immune system with new cells that are better able to attack and kill cancer cells.
Who is the study for?
This trial is for patients with recurrent or refractory ovarian, fallopian tube, or primary peritoneal cancer who have tried at least one standard therapy. They must be in good physical condition (ECOG 0-1), not pregnant, and agree to use birth control. Participants need proper organ function and no active infections like HIV/HBV/HCV/CMV.
What is being tested?
The trial tests genetically engineered immune cells (NY-ESO-1 TCR T cells) combined with stem cells after chemotherapy with melphalan. The goal is to see if this can better target and kill cancer cells by rebuilding the patient's immune system to fight the cancer more effectively.
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal tissues, infusion-related reactions from cell transplants, increased risk of infection due to weakened immunity from chemotherapy, and general side effects such as fatigue or nausea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events
Maximum tolerated dose (MTD)
Secondary study objectives
Appearance of target antigen/major histocompatibility complex loss variants upon disease recurrence
Assessment of bioactivity
Progression-free survival
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (autologous NY-ESO-1 engineered T and HSC)Experimental Treatment4 Interventions
Patients receive melphalan IV over 30 minutes on day -1. Patients then receive autologous NY-ESO-1 CD4-TCR CD34+ HSC IV on day 0 and autologous NY-ESO-1-specific CD8-positive T lymphocytes IV between days 7 and 21. Patients also receive aldesleukin SC BID for 14 days on the following day after the T cell infusion (between days 8 and 22).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldesleukin
2012
Completed Phase 4
~1620
Autologous NY-ESO-1-specific CD8-positive T Lymphocytes
2015
Completed Phase 1
~20
Melphalan
2008
Completed Phase 3
~1500
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
408 Previous Clinical Trials
32,414 Total Patients Enrolled
4 Trials studying Ovarian Cancer
63 Patients Enrolled for Ovarian Cancer
Emese Zsiros, MDPrincipal InvestigatorRoswell Park Cancer Institute
3 Previous Clinical Trials
68 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have active brain metastases, unless they have been successfully treated with surgery or radiation and are under control.You have had allergic reactions to similar medications in the past.You have taken certain medications like corticosteroids or immunomodulating agents within the last 30 days.You are able to perform daily activities without difficulty or with a little difficulty.You need to have a specific genetic marker called HLA-A*02.1 and HLA-DP*04. If you have already been tested positive for these markers before, you don't need to be tested again.You have had a heart attack in the past 6 months, serious heart rhythm problems, or severe congestive heart failure. If needed, a heart stress test will be done by the study doctor.You have a specific type of ovarian, peritoneal, or fallopian tube cancer that has come back after treatment, and you have already tried at least one standard treatment for this type of cancer.You are expected to live for more than 4 months.Your platelet count is at least 100 billion per liter.Your tumor must test positive for NY-ESO-1 using a specific type of test.You have an ongoing infection with HIV, hepatitis B, hepatitis C, or cytomegalovirus.You are not able to come in for check-up appointments.You had another type of cancer, except for non-melanoma skin cancer, within the past 3 years.Your white blood cell count is equal to or greater than 3 billion per liter.You have breathing test results that show abnormalities.Your disease must be able to be measured using specific guidelines.Your white blood cell count is at least 1.5 billion per liter.Your bilirubin levels are within the normal range for the hospital or clinic where you are being treated.Your AST and ALT levels in the blood are not more than 2.5 times the normal limit for the testing facility.Your creatinine level should be within a certain range, and if it's higher, your kidneys need to work well.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (autologous NY-ESO-1 engineered T and HSC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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