NY-ESO-1-Specific T-cells in Treating Patients With Advanced NY-ESO-1-Expressing Sarcomas Receiving Palliative Radiation Therapy

NCT02319824 | Completed Phase 1 Results DMC

• 5 other identifiers: 2721.00NCI-2014-021542721K23CA175167P30CA015704
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot, phase I trial studies the safety of cancer-testis antigen (NY-ESO-1)-specific T cells (a type of immune cell) in treating patients with NY-ESO-1-expressing sarcomas that have spread to other places in the body and are receiving palliative (relief of symptoms and suffering caused by cancer) radiation therapy. Placing a modified gene for NY-ESO-1 into white blood cells may help the body build an immune response to kill tumor cells that express NY-ESO-1. Palliative radiation therapy may help patients with advanced sarcoma live more comfortably. Giving NY-ESO-1-specific T cells following palliative radiation therapy may be a better treatment for patients with sarcomas.

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03

  CTCAE v4.03

  Up to 12 weeks post-treatment

Secondary Outcomes (2)

• T Cell Transfer Based on Response Evaluation Criteria In Solid Tumors v1.1

  At 6 weeks post-treatment

• Transferred NY-ESO-1-specific T Cells Based on Flow Cytometry Using Major Histocompatibility Complex Tetramers

  Up to 6 weeks post-treatment

Study Arms (1)

Treatment (radiation and NY-ESO-1-specific T cells)

EXPERIMENTAL

Patients undergo palliative radiation therapy at the discretion of the treating radiation oncologist. Patients then receive NY-ESO-1-specific T cells IV over 60 minutes 2-3 days after completion of radiation therapy.

Biological: Autologous NY-ESO-1-specific CD8-positive T Lymphocytes; Other: Laboratory Biomarker Analysis; Radiation: Palliative Radiation Therapy

Interventions

Autologous NY-ESO-1-specific CD8-positive T Lymphocytes BIOLOGICAL

Given IV

Treatment (radiation and NY-ESO-1-specific T cells)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (radiation and NY-ESO-1-specific T cells)

Palliative Radiation Therapy RADIATION

Undergo palliative radiation therapy

Treatment (radiation and NY-ESO-1-specific T cells)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathological documentation of sarcoma
• Patients must express NY-ESO-1 in their tumor by immunohistochemistry (IHC) (\> 5%) prior to leukapheresis
• For leukapheresis, patients must meet the following criteria (any exceptions to this will require prior approval by the apheresis director and principal investigator \[PI\]):
• Pulse \> 45 or \< 120
• Weight \>= 45 kg
• Temperature =\< 38° Celsius (C) (=\< 100.4° Fahrenheit \[F\])
• White blood cell count (WBC) \>= 2,000
• Hematocrit (HCT) \>= 30%
• Platelets \>= 75,000
• A diagnosis of a metastatic or unresectable sarcoma
• Patient must have a biopsy-accessible tumor to be radiated
• Patient must have consulted with a radiation oncologist who is planning radiation; their radiation oncologist should have documented plans to administer a dose of at least 30 Gy in 5 or fewer fractions
• Human leukocyte antigen (HLA) type A0201 or A2402
• Zubrod (Eastern Cooperative Oncology Group \[ECOG\]) performance status of '0-2'
• All patients must have an electrocardiogram (ECG) within 2 weeks of starting conditioning

You may not qualify if:

• Patients with a history of proven myocarditis, pericarditis, or endocarditis
• Pregnant women, nursing women, men and women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within two weeks prior to study entry
• Inadequate renal function as indicated by serum creatinine \>= 1.5 times the upper limit of normal
• Inadequate liver function as indicated by total bilirubin \>= 1.5 times the upper limit of normal
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \>= 2.5 times the upper limit of normal
• Active symptomatic congestive heart failure
• Clinically significant hypotension
• Newly diagnosed cardiac arrhythmia; patients with an arrhythmia that has been stable for at least 3 months will be allowed to participate
• Known untreated central nervous system (CNS) metastasis
• Patients with systemic infections requiring antibiotics or chronic maintenance/suppressive therapy
• Patients receiving systemic anticancer therapy (chemotherapy, "biologics", immunotherapy) less than 2 weeks prior to starting radiation
• Clinically significant autoimmune disorders requiring on-going systemic immune-suppression for control
• Patients with acquired immunodeficiency syndrome (AIDS) or who are known to be human immunodeficiency virus (HIV) positive are not eligible for this study; testing may have been done up to 3 months prior to treatment
• Current treatment with steroids
• Known infection with hepatitis B virus (HBV) and hepatitis C virus (HCV); testing may have been done up to 3 months prior to treatment

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Limitations and Caveats

This trial was ended early as persistence was not at the level we had hoped and we had the opportunity to pursue a more promising strategy. The data is limited by having only 2 patients.

Results Point of Contact

• Title: Seth Pollack
• Organization: Fred Hutchinson Cancer Research Center

spollack@fhcrc.org

206-667-6629

Study Officials

• Seth Pollack

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsible Party

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: December 18, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Last Updated: July 5, 2017
• Results First Posted: July 5, 2017

Record last verified: 2017-04

Locations

US (1)