NY-ESO-1 Specific T Cells After Cyclophosphamide in Treating Patients With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

NCT02059850 | Withdrawn Phase 1 DMC

• 4 other identifiers: 2720.00NCI-2013-02464K23CA175167P30CA015704
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies the side effects and best way to give NY-ESO-1 specific T cells after cyclophosphamide in treating patients with advanced synovial sarcoma or myxoid/round cell liposarcoma. Placing a gene that has been created in the laboratory into white blood cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving NY-ESO-1 specific T cells with cyclophosphamide may kill more tumor cells.

Conditions

Adult Synovial Sarcoma; Myxoid/Round Cell Liposarcoma; Recurrent Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Incidence of grade III or greater toxicity graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0

  The type and grade of toxicities noted during therapy will be summarized for each dose level. All adverse events noted by the investigator will be tabulated according to the affected body system. Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters.

  Up to 10 weeks

Secondary Outcomes (2)

• Persistence of tetramer positive T cells

  At 4 weeks

• Persistence of tetramer positive T cells

  At 10 weeks

Study Arms (1)

Treatment (cyclophosphamide, NY-ESO-1 specific T cells)

EXPERIMENTAL

Patients receive cyclophosphamide IV on days -3 and -2 and NY-ESO-1 specific T cells IV over 60 minutes on day 0. Patients may receive additional infusions at the discretion of the PI.

Biological: Autologous NY-ESO-1-specific CD8-positive T Lymphocytes; Drug: Cyclophosphamide; Other: Laboratory Biomarker Analysis

Interventions

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

Given IV

Treatment (cyclophosphamide, NY-ESO-1 specific T cells)

Cyclophosphamide DRUG

Given IV

Treatment (cyclophosphamide, NY-ESO-1 specific T cells)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (cyclophosphamide, NY-ESO-1 specific T cells)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical history including histopathological documentation of sarcoma
• Informed consent and Health Insurance Portability and Accountability Act (HIPAA) signing
• CRITERIA FOR LEUKAPHERESIS:
• NY-ESO-1 expression in tumor by immunohistochemistry (IHC) is not required prior to screening consent; however, patients must have NY-ESO-1 expression to proceed with the leukapheresis; additionally patients must also meet the following criteria to proceed with leukapheresis (any exceptions to this will require prior approval by the Apheresis director and Principal Investigator):
• Physical exam and Karnofsky performance status
• Laboratory evaluation:
• Complete blood count (CBC), differential and platelet count
• Basic metabolic and hepatic function panels
• Puget Sound Blood Center Recipient Donor Battery Panel
• Pregnancy test for females of child-bearing potential
• Pulse \> 45 and \< 120
• Weight \>= 45 kg
• Temperature =\< 38 Celsius (C) (=\< 100.4 Fahrenheit \[F\])
• White blood cell (WBC) \>= 2,000
• Hematocrit (HCT) \>= 30%

You may not qualify if:

• Patients for whom we are unable to generate NY-ESO-1 specific cells
• Pregnant women, nursing women, and 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
• Serum creatinine \> 1.6 mg/dL or glomerular filtration rate \< 50
• Serum glutamic oxaloacetic transaminase (SGOT) \> 150 IU or \> 3 x upper limit of normal
• Bilirubin \> 1.6 mg/dL
• Prothrombin time \> 1.5 x control
• Active symptomatic congestive heart failure
• Clinically significant hypotension (systolic blood pressure \[SBP\] \< 80 mm HG or symptomatic)
• Newly diagnosed cardiac arrhythmia; patients with an arrhythmia that has been stable for at least 6 months will be allowed to participate
• Known untreated central nervous system (CNS) metastasis; patients with CNS metastasis will be allowed on study once treated
• Patients with active systemic infections requiring antibiotics or chronic maintenance/suppressive therapy; once the infection in question has resolved and patient is off antimicrobial treatment, patients may participate
• Systemic anticancer treatments (including chemotherapy and biologics) less than 3 weeks prior to T cell therapy; locally directed therapy (e.g. radiation) 2 weeks prior to cell infusion
• Known clinically significant autoimmune disorders requiring systemic immunosuppression for control
• Patients who are known to be human immunodeficiency virus (HIV) positive are not eligible for this study
• Current treatment with steroids

Sponsors & Collaborators

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

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Sarcoma, Synovial; Liposarcoma, Myxoid; Sarcoma

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Seth Pollack

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 11, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 3, 2016

Record last verified: 2016-02

Locations

US (1)