Trial record 20 of 77 for:    "Liposarcoma"

Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Fred Hutchinson Cancer Research Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01957709
First received: October 4, 2013
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Adult Liposarcoma
Adult Synovial Sarcoma
Recurrent Adult Soft Tissue Sarcoma
Stage IA Adult Soft Tissue Sarcoma
Stage IB Adult Soft Tissue Sarcoma
Stage IIA Adult Soft Tissue Sarcoma
Stage IIB Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Biological: recombinant interferon gamma
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Change in class I MHC expression after treatment with IFN gamma as determined by immunohistochemistry (IHC) [ Time Frame: Baseline to up to 2 weeks post-surgery ] [ Designated as safety issue: No ]
    It is estimated that the true mean change in expression following IFN gamma will be 50% (for homogenous expression) with a standard deviation of 30%. Seven patients will provide 95% power to observe a change in expression (before IFN vs. after IFN) that is statistically significantly (at the 2-sided significance level of .05) different from a change of zero.


Estimated Enrollment: 12
Study Start Date: September 2013
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Basic science (interferon gamma and MHC expression)
Patients receive recombinant interferon gamma SC every 7 days for 4 weeks before surgery or thrice weekly for 2 weeks before surgery.
Biological: recombinant interferon gamma
Given SC
Other Names:
  • Actimmune
  • gamma interferon
  • IFN-G
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine whether systemic administration of interferon (IFN) gamma (recombinant interferon gamma) will increase class I major histocompatibility complex (MHC) expression in synovial sarcoma (SS) and myxoid/round cell liposarcoma (MRCL) tumors.

SECONDARY OBJECTIVES:

I. To determine whether systemic administration of IFN gamma will increase class II MHC expression in SS and MRCL tumors.

II. To examine changes in the immune response to MRCL and SS by examining changes in the immune infiltrates, antibody response and antigen specific T cell response before and after IFN gamma treatment.

OUTLINE:

Patients receive recombinant interferon gamma subcutaneously (SC) every 7 days for 4 weeks before surgery or thrice weekly for 2 weeks before surgery.

After completion of study, patients are followed up at 2 weeks post-surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of synovial sarcoma and myxoid/round cell liposarcoma
  • All patients must have consulted with a surgical provider and are being considered for resection or biopsy of their tumor
  • Available prior biopsy or tumor resection specimen of lesion to be resected (the target lesion) or biopsied confirming the diagnosis of that lesion and with tissue available for class I MHC staining
  • Zubrod performance status of '0-2'
  • No treatment with systemic anti-cancer treatment (chemotherapy or biologics) within 2 weeks of starting interferon gamma
  • Patients must have an electrocardiogram (EKG) performed within 2 weeks of enrollment; patients with a history of cardiac disease or abnormal EKG 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

Exclusion Criteria:

  • 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
  • Untreated 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) > 150/100mmHg; patients with elevated BP may enroll once BP is corrected
  • Prior cancer/testis antigen 1B (NY-ESO-1) specific T cell therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01957709

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Seth Pollack    206-667-6629      
Principal Investigator: Seth Pollack         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Seth Pollack Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01957709     History of Changes
Other Study ID Numbers: 2705.00, NCI-2013-01779, 2705.00, P30CA015704, K12CA076930
Study First Received: October 4, 2013
Last Updated: May 29, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Liposarcoma
Sarcoma
Sarcoma, Synovial
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Adipose Tissue
Neoplasms, Connective Tissue
Interferon-gamma
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 19, 2014