AzTrials
AzTrials

Recurrent Fallopian Tube CarcinomaPhase 1NCT03017131

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

A Phase 1 study testing Aldesleukin, Cyclophosphamide and Decitabine in people with Recurrent Fallopian Tube Carcinoma and Recurrent Ovarian Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This phase I trial studies the side effects of genetically modified T cells and decitabine in treating patients with recurrent or refractory epithelial or non-epithelial ovarian, primary peritoneal, or fallopian tube cancer that has come back or has not responded to previous treatments. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Aldesleukin, Cyclophosphamide and Decitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
8 Dec 2017to 23 Mar 2032
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with recurrent or refractory epithelial or non-epithelial ovarian, primary peritoneal or fallopian tube carcinoma who have received platinum containing chemotherapy and either has platinum refractory or resistant disease, or if plantinum sensitive disease, have received >= 2 lines of chemotherapy. Subjects may have received PARP inhibitators , bevacizumab or immunotherapy. Non-epithelial tumors of the ovary include sarcomas, granulosa cell tumors and malignant germ cell tumors including chiriocarcinoma
  • Have been informed of other treatment options
  • Must be HLA- A*02;01 positive; retesting is not required for patients who have previous documented HLA-A*02;01 positivity
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of > 4 months
  • At least 4 weeks from prior chemotherapy, radiotherapy or immunotherapy, or prior investigational agents
Show all 16Show fewer
  • Must have measurable disease as defined by irRECIST
  • Must have adequate venous access for apheresis; (pheresis catheter placement for cell collection is allowed)
  • Women of childbearing potential in agreement to use acceptable birth control methods for the duration of the study and until persistence of the study drug is no longer detected in the peripheral blood; this may be a period of several years; methods for acceptable birth control include: condoms, diaphragm or cervical cap with spermicide, intrauterine device, and hormonal contraception; it is recommended that a combination of two methods be used
  • Leukocytes >= 3 x 10^9/L
  • Absolute neutrophil count >= 1 x 10^9/L
  • Platelets >= 100 x 10^9/L
  • Total bilirubin within normal institutional limits
  • Aspartate Aminotransferases (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
  • Creatinine level = 2X< upper limit of normal (ULN): if creatinine > 2XULN, creatinine clearance must be > 60ml/min
  • Patient must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Who cannot join

  • Patients receiving any other investigational agents
  • Patients with active brain metastases should be excluded from this clinical trial; patients with prior history of brain metastasis who have undergone local therapy (i.e., metastasectomy and/or radiation) and show no evidence of local recurrence or progression over the past 6 months are eligible. Brain MRI as clinically indicated only
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to cyclophosphamide, decitabine or other agents used in the study
  • Prior malignancy (except non melanoma skin cancer) within 3 years
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
  • Use of chronic corticosteroids, hydroxyurea, or immunomodulating agents (e.g., interleukin 2, interferon alpha or gamma, granulocyte colony stimulating factors, etc.) within 30 days prior to study entry
Show all 17Show fewer
  • NOTE: recent or current use of inhaled steroids is not exclusionary; if subjects are prescribed a brief course of oral corticosteroids, the use should be limited to less than 7 days
  • 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
  • Positive serology for HIV
  • Active hepatitis B infection as determined by a positive test for hepatitis B surface antigen (Ag)
  • Active hepatitis C; patients will be screened for HCV antibody; if the HCV antibody is positive, a screening HCV ribonucleic acid (RNA) by any real time polymerase chain reaction (RT PCR) or branched deoxyribose nucleic acid (bDNA) assay must be performed at screening by a local laboratory with a Clinical Laboratory Improvement Act (CLIA) certification or its equivalent; eligibility will be determined based on a negative screening value; the test is not required if documentation of a negative result of a HCV RNA test performed within 60 days prior to screening is provided
  • Serology (CMV immunoglobulin G [IgG]) positive for active CMV
  • Received any previous gene therapy using an integrating vector within 6 months
  • Pregnancy or breast-feeding
  • Lack of availability of a patient for immunological and clinical follow up assessment
  • Evidence or history of significant cardiac disease (including evidence or history of significant cardiac disease (including myocardial infarction [MI] in the past 6 months, significant cardiac arrhythmia, stage III or IV congestive heart failure [CHF]); cardiac stress test will be done as clinically indicated; (the specific test to be chosen at the discretion of the principal investigator [PI])
  • Patients with pulmonary function test abnormalities as evidenced by a forced expiratory volume in 1 second to forced vital capacity ratio measurement (FEV1/FVC) < 70% of predicted for normality will be excluded

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

Official title: A Phase I Open Label Clinical Trial Evaluating the Safety and Efficacy of Adoptive Transfer of NY-ESO-1 TCR Engineered Autologous T Cells in Combination With Decitabine in Patients With Recurrent or Treatment Refractory Ovarian Cancer

This phase I trial studies the side effects of genetically modified T cells and decitabine in treating patients with recurrent or refractory epithelial or non-epithelial ovarian, primary peritoneal, or fallopian tube cancer that has come back or has not responded to previous treatments. White blood cells called T cells are collected via a process called leukapheresis, genetically modified to recognize and attack tumor cells, then given back to the patient. Decitabine may induce and increase the amount of the target protein NY-ESO-1 available on the surface of tumor cells. Giving genetically modified T cells and decitabine may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the safety and tolerability of the autologous NY-ESO-1 redirected T cell therapy in combination with decitabine and low-dose IL-2 in patients with treatment refractory or recurrent epithelial or non-epithelial ovarian, primary peritoneal or fallopian tube carcinoma.

SECONDARY OBJECTIVES:

  1. To evaluate the persistence of genetically modified cells in the peripheral blood, and at tumor sites.

II. To examine the effect of the treatment on tumor as measured by objective tumor response and progression free survival, both assessed by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST).

III. To assess the occurrence of target antigen and/or major histocompatibality complex (MHC) loss variants upon disease recurrence.

TERTIARY OBJECTIVES:

  1. To evaluate the post treatment phenotype and functionality of genetically modified T cells isolated from peripheral blood and from tumor sites.

II. To assess changes in immunoscore, Tregs, Myeloid cell subsets, and antigen spreading in peripheral blood and tumor site.

III. To assess the influence of demographic and disease molecular characteristics on treatment outcomes of complete response (CR) and overall survival (OS).

OUTLINE:

COURSE 1: Patients receive decitabine IV daily over 1 hour on days -8 to Day -6, cyclophosphamide IV over 2 hours on days -4 and -3, and genetically engineered NY-ESO-1-specific T lymphocytes IV and intraperitoneally (IP) on day 0. Followed by low-dose IL-2 for 2 weeks from Day 1 to Day 14..

After completion of study treatment, patients are followed up monthly at 3-9 months, every 6 months for 4 years, and then annually for up to 15 years.

Being tested
Aldesleukin, Cyclophosphamide, Decitabine, Genetically Engineered NY-ESO-1-specific T Lymphocytes, Laboratory Biomarker Analysis
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AldesleukinBiological

    Also called 125-L-Serine-2-133-interleukin 2, Proleukin, r-serHuIL-2, Recombinant Human IL-2

    Given SC

  • CyclophosphamideDrug

    Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida

    Given IV

  • DecitabineDrug

    Also called 5-Aza-2'-deoxycytidine, Dacogen, Decitabine for Injection, Deoxyazacytidine

    Given IV

  • Genetically Engineered NY-ESO-1-specific T LymphocytesBiological

    Given IV and IP

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT03017131
Study groupRoleWhat they receive
Treatment (decitabine, genetically modified T cells)ExperimentalCOURSE 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..
Receives: Biological: Aldesleukin; Drug: Cyclophosphamide; Drug: Decitabine; Biological: Genetically Engineered NY-ESO-1-specific T Lymphocytes; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The frequency of toxicities will be tabulated by grade across all dose levels and cycles.

    Measured: Up to 28 days post infusion

Secondary outcomes (6)

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

    Will be evaluated by quantifying expression of targeted antigens/major histocompatibility complex alleles (NY-ESO-1/human leukocyte antigen-A*02) in tumor samples obtained on disease recurrence if available, and comparing those values to the pretreatment (diagnosis) samples. NY-ESO-1 expression will be evaluated by quantitative real time polymerase chain reaction immunohistochemistry. Human leukocyte antigen-A*0201 expression on samples will be evaluated by immunohistochemistry.

    Measured: Up to 15 years

  2. Clinical response rates

    Percentage of complete and partial responses and the corresponding 95% confidence interval will be calculated.

    Measured: Up to 15 years

  3. Duration of response

    Will be observed.

    Measured: Up to 15 years

  4. Immunological parameters associated with T cell persistence, bioactivity and functionality

    Will measure the pre- and post-treatment percentage of transgenic T cells in the peripheral blood, selective migration into the tumor sites, the ex-vivo immune functionality and phenotype of these cells, the modulation of cytokine milieu in serum post treatment as compared to baseline as well as the development of an expanded patient immune response against tumor via epitope spreading.

    Measured: Up to 15 years

  5. Overall survival

    Will be observed.

    Measured: Up to 15 years

  6. Progression free survival

    The median progression free survival and the corresponding 95% confidence interval will be calculated.

    Measured: Up to 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2017 (estimated)
  2. Study start8 Dec 2017
  3. Primary completion23 Mar 2020
  4. Study completion23 Mar 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03017131
Sponsor's protocol ID
i 283616
Other IDs
NCI-2016-01477, i 283616, P30CA016056, P50CA159981
Status last verified
Mar 2026
First submitted
19 Oct 2016
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Aldesleukin, Cyclophosphamide and Decitabine in people with Recurrent Fallopian Tube Carcinoma and Recurrent Ovarian Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events as defined by National Cancer Institute Common Terminology Criteria for Adverse Events version 4 (time frame: Up to 28 days post infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03017131.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in