Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma

NCT01957709 | Terminated Early Phase 1 Results DMC FDA Drug

• 6 other identifiers: 2705.00NCI-2013-017792705K12CA076930K23CA175167P30CA015704
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies the effect of recombinant interferon gamma on tissue in treating patients with soft tissue sarcoma. Interferon gamma may interfere with the growth of tumor cells.

Conditions

Myxoid Liposarcoma; Round Cell Liposarcoma; Synovial Sarcoma

Outcome Measures

Primary Outcomes (1)

• Change in Class I Major Histocompatibility Complex (MHC) Expression After Treatment With IFN Gamma

  It would be highly relevant to observe marked increase macrophages (effect size \> 2.5). Four patients gives over 90% power to detect such a large increase with a two-tailed alpha of 0.05.

  Baseline to up to 2 weeks post-surgery

Secondary Outcomes (2)

• MHC Class II Expression

  Baseline to 2 weeks post biopsy.

• Changes in Immune Response

  Baseline to 2 weeks post biopsy

Study Arms (1)

Basic science (interferon gamma and MHC expression)

EXPERIMENTAL

Patients receive recombinant interferon gamma subcutaneously weekly for 4 weeks before surgery.

Other: Laboratory Biomarker Analysis; Biological: Recombinant Interferon Gamma

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Basic science (interferon gamma and MHC expression)

Recombinant Interferon Gamma BIOLOGICAL

Given subcutaneously weekly for four weeks prior to surgery.

Also known as: Gamma Interferon (GEN), Gamma Interferon-SCH, Gamma-Interferon, Ginterferon, IFN-g, Interferon Gamma, Interferon Gamma (BIO), Interferon, Gamma

Basic science (interferon gamma and MHC expression)

Eligibility Criteria

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

You may qualify if:

• A diagnosis of synovial sarcoma and myxoid/round cell liposarcoma
• Male or female subject, 18 or older
• A superficial tumor easily and safely accessible for a research biopsy or are being considered for resection or biopsy of their tumor as part of standard of care and have recent pathology.
• Zubrod performance status of '0-2' or Karnofsky score \> 60%
• No treatment with systemic anti-cancer treatment (chemotherapy or biologics) within 2 weeks of starting interferon gamma
• Patients with a history of coronary artery disease must have had a normal stress test within 180 days of starting IFN gamma
• Must have been off metformin for at least 2 weeks prior to starting IFN gamma
• No use of full dose, therapeutic anti-coagulation. However, low dose warfarin for catheter prophylaxis or acetylsalicylic acid are acceptable.
• No thrombotic event within 6 months (deep vein thrombosis, pulmonary embolism) of starting IFN gamma

You may not qualify if:

• Active infection requiring oral or intravenous antibiotics
• Pregnant women, nursing mothers, men or 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 entry.
• Serum creatinine \> 1.5 mg/dL or Glomerular Filtration Rate \< 50
• Significant hepatic dysfunction (SGOT \> 150 IU or \> 3x upper limit of normal; bilirubin \> 1.6 mg/dL; prothrombin time \> 1.5x control).
• Known central nervous system (CNS) metastasis. Once CNS metastasis have been treated these patients may participate if they are otherwise good trial candidates.
• Current treatment with steroids (must be discontinued 1 week before starting IFN gamma)
• Hemoglobin A1C \> 8.5%
• Uncontrolled hypertension, blood pressure (BP) \> 150/100 mmHg; patients with elevated BP may enroll once BP is corrected
• Cancer/testis antigen 1B (NY-ESO-1) specific T cell therapy within 1 year of starting on the trial
• New (\< 6 months) cardiac arrhythmia (electrocardiogram \[EKG\] should be performed within 2 weeks of starting IFN gamma).
• History of clinically significant congestive heart failure.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Horizon Pharma USA, Inc.: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Schroeder BA, Black RG, Spadinger S, Zhang S, Kohli K, Cao J, Mantilla JG, Conrad EU, Riddell SR, Jones RL, Yee C, Pollack SM. Histiocyte predominant myocarditis resulting from the addition of interferon gamma to cyclophosphamide-based lymphodepletion for adoptive cellular therapy. J Immunother Cancer. 2020 Apr;8(1):e000247. doi: 10.1136/jitc-2019-000247.

  PMID: 32269142 DERIVED

MeSH Terms

Conditions

Liposarcoma, Myxoid; Sarcoma, Synovial

Interventions

Interferon-gamma

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Macrophage-Activating Factors; Lymphokines; Proteins; Biological Factors

Limitations and Caveats

Early termination of trial due to collection of enough data necessary to complete analysis.

Results Point of Contact

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

spollack@fredhutch.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: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 100 mcg/m2 weekly injection for four weeks

Study Record Dates

• First Submitted: October 4, 2013
• First Posted: October 8, 2013
• Study Start: September 25, 2013
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 10, 2019
• Results First Posted: July 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)