Phase 1 N=2 Treatment

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

Sarcoma

Bottom Line

View on ClinicalTrials.gov: NCT02319824 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcome: Primary: Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03 — 1; 1; 1; 1 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Autologous NY-ESO-1-specific CD8-positive T Lymphocytes (Biological); Laboratory Biomarker Analysis (Other); Palliative Radiation Therapy (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Fred Hutchinson Cancer Center
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03	1; 1; 1; 1	—
SECONDARY T Cell Transfer Based on Response Evaluation Criteria In Solid Tumors v1.1	1; 1	—
SECONDARY Transferred NY-ESO-1-specific T Cells Based on Flow Cytometry Using Major Histocompatibility Complex Tetramers	2; 0	—

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.

Eligibility Criteria

Inclusion Criteria

INCLUSION CRITERIA FOR SCREENING:

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 = 45 kg
Temperature = = 2,000
Hematocrit (HCT) >= 30%
Platelets >= 75,000

INCLUSION CRITERIA FOR TREATMENT:

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
All patients must have an echo or multigated acquisition (MUGA) scan showing ejection fraction (EF) > 50% and normal troponin and creatine kinase MB (CK MB) performed within 90 days of starting treatment

Exclusion Criteria

EXCLUSION CRITERIA FOR SCREENING:

Patients who do not meet the above inclusion criteria will not receive leukapheresis

EXCLUSION CRITERIA FOR TREATMENT:

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02319824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.