Genetically Engineered NY-ESO-1-specific T Lymphocytes for Relapse

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Roswell Park Cancer Institute, Buffalo, NY
Relapse+4 More
Genetically Engineered NY-ESO-1-specific T Lymphocytes - Biological
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether genetically modified T cells and decitabine may be safe and effective 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.

See full description

Eligible Conditions

  • Relapse
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Primary Peritoneal Carcinoma

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Genetically Engineered NY-ESO-1-specific T Lymphocytes will improve 1 primary outcome and 6 secondary outcomes in patients with Relapse. Measurement will happen over the course of Up to 28 days post infusion.

Up to 15 years
Appearance of target antigen/major histocompatibility complex loss variants upon disease recurrence
Clinical response rates
Duration of response
Immunological parameters associated with T cell persistence, bioactivity and functionality
Overall survival
Progression free survival
Day 28
Incidence of adverse events as defined by National Cancer Institute Common Terminology Criteria for Adverse Events version 4

Trial Safety

Trial Design

1 Treatment Group

Treatment (decitabine, genetically modified T cells)
1 of 1
Experimental Treatment

This trial requires 9 total participants across 1 different treatment group

This trial involves a single treatment. Genetically Engineered NY-ESO-1-specific T Lymphocytes is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Treatment (decitabine, genetically modified T cells)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
Cyclophosphamide
FDA approved
Decitabine
FDA approved
Aldesleukin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 15 years for reporting.

Closest Location

Roswell Park Cancer Institute - Buffalo, NY

Eligibility Criteria

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Relapse or one of the other 4 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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
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

Patient Q&A Section

What are the signs of carcinoma?

"The following signs are related to early carcinoma: elevated body temperature, an irregular bowel movement, weight loss and/or dehydration, and a lump in the breast. The signs are present only a few days or weeks before diagnosis, and do not always occur with tumor." - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma a year in the United States?

"Incidence of cancer continues to rise in this population. Current population estimate of cancer incidence is 20-fold higher than the estimate from the 1970 U.S. census. Future trends are likely to be greater, given the demographic shifts in the US." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma?

"Tumor type or grade is an important consideration in treatment, and cancer treatment is broadly categorized into two categories: curative or palliative. More aggressive tumor or metastatic disease is often treated with chemotherapy, surgery, or radiotherapy. More localized disease is treated with surgery, chemotherapy, or radiation therapy. Non-curative therapy options, especially if systemic metastases are present, are often used in combination with multiple treatments in an effort to prolong survival. Chemotherapy typically includes anthracyclines, taxanes, and epoetins. Targeted therapy agents, including agents targeting the epidermal growth factor receptor or the vascular endothelial growth factor pathway, are used to treat lung cancer with metastases." - Anonymous Online Contributor

Unverified Answer

Can carcinoma be cured?

"For most patients, curative treatments include: surgery, such as a curative excision, radical mastectomy, or mastectomy with (chemo)-radiation or chemo-radiation alone; radiotherapy and radiochemotherapy. For all but two of our patients we also used the following: chemotherapy or chemotherapy-radiotherapy with corticoid-cimetidine, which in several patients brought some good results." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma?

"The majority of cancers are non-hereditary, probably related to a combination of genetic and environmental factors, especially tobacco smoking and exposure to carcinogens in many workplaces, as well as diet and other lifestyles that are related to the development of certain types of cancer." - Anonymous Online Contributor

Unverified Answer

What is carcinoma?

"While cancer, of course, can be the first or second indication for surgery, it can also be metastatic or the recurrence of an earlier surgical procedure. For a few cancers, there are effective treatment options. In most types of cancer, you cannot avoid the risks associated with treatment (particularly complications following surgery) if the patient intends to undergo surgery. Use the [Power(http://www.withpower.com/clinical-trials/tumor-treatments-clinical-trials)\n\n- powerlawit\n- powerlawit.org\n- powerlawit." - Anonymous Online Contributor

Unverified Answer

What is genetically engineered ny-eso-1-specific t lymphocytes?

"TCRs of the ny-eso-1-specific repertoire recognise only a part of the peptide epitope of pny-1. These data should help in further elucidating the mechanism, and possibly improving generation of MHC class II-restricted ny-eso-1-reactive TCRs against an epitope restricted antigen and for the treatment of CML." - Anonymous Online Contributor

Unverified Answer

Does genetically engineered ny-eso-1-specific t lymphocytes improve quality of life for those with carcinoma?

"Data from a recent study indicate that ny-eso-1-specific CTLs exert the antitumor effect and decrease tumor-associated cytokines in patients with esophageal carcinoma. Moreover, the clinical effect appears long-lasting. Data from a recent study suggest that adoptive transfer of cancer-specific cytotoxic T-cells may have the potential for clinical use in a large proportion of patients with esophageal cancer." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for carcinoma?

"The survival rate for carcinoma was 34.4% for patients who were diagnosed during 1978–79 and 38.4% for those diagnosed during 1981–85 at the Mayo Clinic. Survival was not significantly higher for patients diagnosed at all centers. A better understanding of the relationship between survival and treatment is needed." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of genetically engineered ny-eso-1-specific t lymphocytes?

"Findings from a recent study on the effectiveness of a tn-eso-1 vaccine suggest that in the study in rhesus monkeys the most likely side effects were related to the development of GVHD and the production of autoantibodies. An efficient preparation (vaccine-induced esophageal toxicity-free) was created with a low side risk. In contrast to our in vitro data on IL-17, it turned out that the most popular cytokine was TNF-α." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing carcinoma?

"Carcinoma is a fatal disease that affects approximately 300,000 people in the United States each year. In the [early stages] it may be curable with cancer surgery. However, in the [later stages] it can spread to distant sites. This leads to the patient suffering through prolonged morbidity and high mortality. When an individual is diagnosed with carcinoma, the possibility that they may be cured can be very high. However, those with cancer have very few good treatments. These patients experience side effects from chemotherapy in addition to surgery, radiation, and other treatment options. To [find out who is most likely to benefit from cancer treatment,] ask their physicians for a [prognostic score](power." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for carcinoma?

"There are no clear indications for performing a clinical trial in patients with advanced carcinoma. Some indications exist and most of these are already used in clinical practice. The type of information that would be useful in the indication for a clinical trial is difficult to define. We discuss the potential uses of a clinical trial on the basis of current knowledge and clinical guidelines." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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