What side effects are associated with this type of intervention?

Common treatments for Fallopian Tube Cancer, such as chemotherapy with paclitaxel and carboplatin, can cause side effects including neurotoxicity, granulocytopenia, anemia, and general toxicity. Immunotherapy, including genetically modified T cells, may lead to immune-related side effects like cytokine release syndrome, fever, fatigue, and potential organ inflammation. Decitabine, used to increase tumor cell visibility, can cause myelosuppression and gastrointestinal symptoms like nausea and vomiting.

What prior FDA approvals exist?

FDA-approved treatments for Fallopian Tube Cancer often overlap with those for ovarian and peritoneal cancers due to their similar histology and behavior. Traditional chemotherapy agents such as carboplatin and paclitaxel are commonly used. Bevacizumab, an anti-angiogenic agent, has also been approved for use in combination with chemotherapy for recurrent cases. While there are no specific FDA approvals for genetically modified T cells or decitabine in Fallopian Tube Cancer, these treatments are being explored in clinical trials for their potential to enhance immune response and increase tumor cell visibility, respectively.

What other types of research exist?

Promising novel alternatives for fallopian tube cancer treatment in 2024 include TAS-117 (a PI3K/AKT/mTOR pathway inhibitor), aspirin-PC (a safer form of aspirin with antitumor effects), NVP-BEZ235 (a dual PI3K/mTOR inhibitor), and humanized anti-Sialyl-Tn antibodies. These therapies have shown potential in preclinical or clinical studies for inhibiting tumor growth and improving patient outcomes.

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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)

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements

Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV) as defined below, due to the immunosuppressive effects of cyclophosphamide used and the unknown risks associated with viral replication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a treatment combining enhanced immune cells and a drug to target difficult-to-treat ovarian and related cancers. The approach aims to improve the body's ability to find and destroy cancer cells.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any ongoing illnesses or social situations that would prevent me from following the study's requirements.

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I do not have an active infection with HIV, HBV, HCV, or CMV.

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I have not had gene therapy with an integrating vector in the last 6 months.

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I haven't had cancer (other than non-melanoma skin cancer) in the last 3 years.

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I am allergic to medications similar to cyclophosphamide or decitabine.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Clinical response rates

Duration of response

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1610

Cyclophosphamide

2010

Completed Phase 4

~2310

Decitabine

2004

Completed Phase 3

~1680

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Genetically modified T cells are engineered to recognize and directly attack tumor cells, enhancing the body's immune response against cancer. Decitabine, on the other hand, increases the visibility of tumor cells to the immune system by inducing the expression of specific proteins on their surface. For Fallopian Tube Cancer patients, these treatments are significant because they offer a targeted approach to eliminate cancer cells while potentially reducing the side effects associated with traditional chemotherapy. This dual mechanism not only aims to improve the efficacy of treatment but also to provide a more personalized and less toxic therapeutic option.

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