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Clinical Trial Detail

Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma

Complete title: 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

Research Study Number 2705.00
Principal Investigator Seth Pollack
Phase Pilot

Research Study Description

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.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older (Adult, Senior)

Sexes Eligible for Study: All

- A diagnosis of synovial sarcoma and myxoid/round cell liposarcoma

- 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

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- 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

- 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

- 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

Other exclusion criteria may apply.

Research Study Number 2705.00
Contact Seattle Cancer Care Alliance Intake Office
Telephone 800-804-8824 / 206-606-1024

Keywords: Sarcoma; Solid Tumors; Neoplasms; Sarcoma, Synovial; Liposarcoma, Myxoid/Round Cell; Liposarcoma; Neoplasms, Connective and Soft Tissue; Immunotherapy

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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