Myxoid LiposarcomaEarly Phase 1NCT01957709
Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma
A Early Phase 1 study testing Laboratory Biomarker Analysis and Recombinant Interferon Gamma in people with Myxoid Liposarcoma and Round Cell Liposarcoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myxoid Liposarcoma, Round Cell Liposarcoma, Synovial Sarcoma
- What is being tested?
- Laboratory Biomarker Analysis and Recombinant Interferon Gamma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2013to 1 Jun 2018
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
After completion of study, patients are followed up at 2 weeks post-surgery.
- Conditions
- Myxoid Liposarcoma, Round Cell Liposarcoma, Synovial Sarcoma
- Being tested
- Laboratory Biomarker Analysis, Recombinant Interferon Gamma
- Medical subject headings
- Liposarcoma, Myxoid, Sarcoma, Synovial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Recombinant Interferon GammaBiological
Also called Gamma Interferon (GEN), Gamma Interferon-SCH, Gamma-Interferon, Ginterferon
Given subcutaneously weekly for four weeks prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Basic science (interferon gamma and MHC expression) | Experimental | Patients receive recombinant interferon gamma subcutaneously weekly for 4 weeks before surgery. Receives: Other: Laboratory Biomarker Analysis; Biological: Recombinant Interferon Gamma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to up to 2 weeks post-surgery
Secondary outcomes (2)
MHC Class II Expression
To determine whether systemic administration of IFNg will increase class II MHC expression in SS and MRCL tumors.
Measured: Baseline to 2 weeks post biopsy.
Changes in Immune Response
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 IFNg treatment.
Measured: Baseline to 2 weeks post biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study start25 Sep 2013
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Why it stopped: Enough samples were collected for data analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myxoid LiposarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 100 mcg/m2 weekly injection for four weeks
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Horizon Pharma USA, Inc.
- Responsible party
- Sponsor
- Investigators
- Seth Pollack, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957709
- Sponsor's protocol ID
- 2705.00
- Other IDs
- NCI-2013-01779, 2705, 2705.00, K12CA076930, K23CA175167, P30CA015704
- Status last verified
- Jun 2019
- First submitted
- 4 Oct 2013
- Last updated
- 10 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32269142
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01957709
- Acronym / sponsor ID
- 2705.00
- Conditions
- Myxoid Liposarcoma, Round Cell Liposarcoma, Synovial Sarcoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enough samples were collected for data analysis.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Horizon Pharma USA, Inc.
- Study start
- 25 Sep 2013 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Posted 10 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
After completion of study, patients are followed up at 2 weeks post-surgery.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 100 mcg/m2 weekly injection for four weeks
| Arm | Type | Receives |
|---|---|---|
| Basic science (interferon gamma and MHC expression) | Experimental | Other: Laboratory Biomarker Analysis, Biological: Recombinant Interferon GammaPatients receive recombinant interferon gamma subcutaneously weekly for 4 weeks before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Basic science (interferon gamma and MHC expression) |
| Recombinant Interferon GammaAlso: Gamma Interferon (GEN), Gamma Interferon-SCH, Gamma-Interferon, GinterferonGiven subcutaneously weekly for four weeks prior to surgery. | Biological | Basic science (interferon gamma and MHC expression) |
Primary outcome
Change in Class I Major Histocompatibility Complex (MHC) Expression After Treatment With IFN Gamma
Time frame: Baseline to up to 2 weeks post-surgery
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.
2 secondary outcomes
MHC Class II Expression
Time frame: Baseline to 2 weeks post biopsy.
Changes in Immune Response
Time frame: Baseline to 2 weeks post biopsy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32269142Schroeder 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seth Pollack principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Laboratory Biomarker Analysis and Recombinant Interferon Gamma in people with Myxoid Liposarcoma and Round Cell Liposarcoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Class I Major Histocompatibility Complex (MHC) Expression After Treatment With IFN Gamma (time frame: Baseline to up to 2 weeks post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01957709, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.