Clinical trial · Interventional
Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma
A Pilot Study to Test Whether Systemic Interferon Gamma Increases Tumor Class I MHC Expression in Patients With Synovial Sarcoma and Myxoid/Round Cell Liposarcoma
NCT01957709CI-TRIAL-00039430terminatedEarly Phase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Enough samples were collected for data analysis.
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myxoid Liposarcoma | Myxoid Liposarcoma | ONTOLOGY_EXACT | 0.98 |
| Round Cell Liposarcoma | Round Cell Liposarcoma | ONTOLOGY_EXACT | 0.98 |
| Synovial Sarcoma | Synovial Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Recombinant Interferon Gamma | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Basic science (interferon gamma and MHC expression)
- description
- Patients receive recombinant interferon gamma subcutaneously weekly for 4 weeks before surgery.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Biological: Recombinant Interferon Gamma
Primary outcomes (1)
- measure
- Change in Class I Major Histocompatibility Complex (MHC) Expression After Treatment With IFN Gamma
- timeFrame
- Baseline to up to 2 weeks post-surgery
- description
- 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.
Secondary outcomes (2)
- measure
- MHC Class II Expression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. A diagnosis of synovial sarcoma and myxoid/round cell liposarcoma 2. Male or female subject, 18 or older 3. 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. 4. Zubrod performance status of '0-2' or Karnofsky score \> 60% 5. No treatment with systemic anti-cancer treatment (chemotherapy or biologics) within 2 weeks of starting interferon gamma 6. Patients with a history of coronary artery disease must have had a normal stress test within 180 days of starting IFN gamma 7. Must have been off metformin for at least 2 weeks prior to starting IFN gamma 8. No use of full dose, therapeutic anti-coagulation. However, low dose warfarin for catheter prophylaxis or acetylsalicylic acid are acceptable. 9. No thrombotic event within 6 months (deep vein thrombosis, pulmonary embolism) of starting IFN gamma Exclusion Criteria: 1. Active infection requiring oral or intravenous antibiotics 2. 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. 3. Serum creatinine \> 1.5 mg/dL or Glomerular Filtration Rate \< 50 4. Significant hepatic dysfunction (SGOT \> 150 IU or \> 3x upper limit of normal; bilirubin \> 1.6 mg/dL; prothrombin time \> 1.5x control). 5. Known central nervous system (CNS) metastasis. Once CNS metastasis have been treated these patients may participate if they are otherwise good trial candidates. 6. Current treatment with steroids (must be discontinued 1 week before starting IFN gamma) 7. Hemoglobin A1C \> 8.5% 8. Uncontrolled hypertension, blood pressure (BP) \> 150/100 mmHg; patients with elevated BP may enroll once BP is corrected 9. Cancer/testis antigen 1B (NY-ESO-1) specific T cell therapy within 1 year of starting on the trial 10. New (\< 6 months) cardiac arrhythmia (electrocardiogram \[EKG\] should be performed within 2 weeks of starting IFN gamma). 11. History of clinically significant congestive heart failure.
References
Publications (1)
- DERIVEDSchroeder 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