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Anti-metabolites

Genetically Modified T Cells + Decitabine 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

At least 4 weeks from prior chemotherapy, radiotherapy or immunotherapy, or prior investigational agents

Must have adequate venous access for apheresis; (pheresis catheter placement for cell collection is allowed)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

Study Summary

This trial is testing the side effects of genetically modified T cells and decitabine to treat ovarian cancer that has returned or didn't respond to previous treatments.

Who is the study for?

This trial is for patients with recurrent or refractory ovarian, primary peritoneal, or fallopian tube cancer. Participants must have HLA-A*02;01 positivity, good performance status (ECOG 0-1), life expectancy over 4 months, adequate organ function and blood counts, measurable disease by irRECIST criteria, and be at least 4 weeks out from prior treatments. Women of childbearing potential must agree to use effective contraception.Check my eligibility

What is being tested?

The trial is testing the safety of genetically modified T cells designed to target NY-ESO-1 protein on tumor cells combined with Decitabine in patients whose cancer has returned or hasn't responded to treatment. Patients' own T cells are collected and engineered before being reintroduced into their body alongside Decitabine to potentially enhance the immune response against cancer.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as fever and fatigue, infusion-related reactions when receiving the modified T cells or drugs used in the process like Aldesleukin and Cyclophosphamide. There may also be an increased risk of infections due to changes in white blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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It has been over 4 weeks since my last cancer treatment.

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I can undergo apheresis, or have a suitable vein for catheter placement.

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I am HLA-A*02;01 positive.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 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

Incidence of adverse events as defined by National Cancer Institute Common Terminology Criteria for Adverse Events version 4

Secondary outcome measures

Appearance of target antigen/major histocompatibility complex loss variants upon disease recurrence

Clinical response rates

Duration of response

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (decitabine, genetically modified T cells)Experimental Treatment5 Interventions

COURSE 1: Patients receive decitabine IV daily over 1 hour on days -8 to -6, cyclophosphamide IV over 2 hours on days -4 and -3, and genetically engineered NY-ESO-1-specific T lymphocytes IV and IP on day 0. Patients also receive aldesleukin SC BID on days 1-14..

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aldesleukin

2012

Completed Phase 4

~1620

Cyclophosphamide

1995

Completed Phase 3

~3780

Decitabine

2004

Completed Phase 3

~1680

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,144 Total Patients Enrolled

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

30,849 Total Patients Enrolled

Emese Zsiros, MDPrincipal InvestigatorRoswell Park Cancer Institute

3 Previous Clinical Trials

63 Total Patients Enrolled

Media Library

Decitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03017131 — Phase 1

Fallopian Tube Cancer Research Study Groups: Treatment (decitabine, genetically modified T cells)

Fallopian Tube Cancer Clinical Trial 2023: Decitabine Highlights & Side Effects. Trial Name: NCT03017131 — Phase 1

Decitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03017131 — Phase 1

Frequently Asked Questions

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

Are individuals still able to enrol in this research study?

"This trial is no longer actively recruiting. Initially posted on December 8th 2017 and edited for the last time March 3rd 2022, this medical study has completed recruitment. If you are still looking for trials to participate in, there are currently 3269 studies with open positions regarding relapse and 934 trials that accept Decitabine candidates."

Answered by AI

Have there been any other investigations into Decitabine's efficacy?

"Currently, there are 934 clinical studies concerning decitabine in active operation. Of those trials, 167 have reached Phase 3 status. Philadelphia holds a fair number of these trials; however, all together there exist 29 528 sites for patients to receive this form of treatment."

Answered by AI

What precautionary measures should be taken when administering Decitabine to participants?

"Due to its Phase 1 status, Decitabine's safety has been tentatively rated a 1 on our scale from Power. This is because there is currently limited data that supports the medication's efficacy and security."

Answered by AI

How many participants can the trial accommodate at its peak?

"Unfortunately, this study is not currently open to new participants. The trial was initially posted on December 8th 2017 and last updated on March 3rd 2022; however, there are other opportunities available as 3269 trials related to relapse studies and 934 Decitabine-focused clinical trials actively recruiting patients."

Answered by AI

In what situations is Decitabine generally prescribed?

"Decitabine is widely known for its effectiveness in treating multiple sclerosis, however, it may also be beneficial to leukemia patients, those with acute myelocytic conditions, retinoblastoma and histiocytic lymphoma."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Genetically Modified T Cells and Decitabine in Treating Patients With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

2017. "Genetically Modified T Cells and Decitabine in Treating Patients With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03017131.

All > Fallopian Tube Cancer > Recurrent Ovarian Cancer