Trial · NCT01957709
Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma
NCT01957709, Early phase 1, Terminated, Fred Hutchinson Cancer Center; results first posted 2019-07-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma. Trials, record NCT01957709. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01957709
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma
- NCT number
- NCT01957709
- Status
- Terminated
- Phases
- Early phase 1
- Enrollment
- 8 participants, actual
- Lead sponsor
- Fred Hutchinson Cancer Center
- Conditions
- Myxoid Liposarcoma, Round Cell Liposarcoma, Synovial Sarcoma
- Interventions
- Laboratory Biomarker Analysis, Recombinant Interferon Gamma
- First posted
- 2013-10-08
- Last updated
- 2019-07-10
- Results first posted
- 2019-07-10
- Limitations and caveats
- Early termination of trial due to collection of enough data necessary to complete analysis.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Class I Major Histocompatibility Complex (MHC) Expression After Treatment With IFN Gamma | 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. |
| Secondary | MHC Class II Expression | Baseline to 2 weeks post biopsy. | To determine whether systemic administration of IFNg will increase class II MHC expression in SS and MRCL tumors. |
| Secondary | Changes in Immune Response | Baseline to 2 weeks post biopsy | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Class I Major Histocompatibility Complex (MHC) Expression After Treatment With IFN Gamma | Baseline to up to 2 weeks post-surgery | percentage of MHC Class I+ on tumor cell | MEDIAN | |
| SECONDARY | MHC Class II Expression | Baseline to 2 weeks post biopsy. | percentage of MHC Class II on tumor cell | MEDIAN | |
| SECONDARY | Changes in Immune Response | Baseline to 2 weeks post biopsy | percentage of T cells | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Class I Major Histocompatibility Complex (MHC) Expression After Treatment With IFN Gamma | Basic Science (Interferon Gamma and MHC Expression) | Pre-treatment | 8.91 | Full Range .131 to 51.6 | percentage of MHC Class I+ on tumor cell |
| Change in Class I Major Histocompatibility Complex (MHC) Expression After Treatment With IFN Gamma | Basic Science (Interferon Gamma and MHC Expression) | Post-treatment | 26.6 | Full Range 1.39 to 92.2 | percentage of MHC Class I+ on tumor cell |
| MHC Class II Expression | Basic Science (Interferon Gamma and MHC Expression) | Pre-treatment | 2.556 | Full Range 0.0 to 6.10 | percentage of MHC Class II on tumor cell |
| MHC Class II Expression | Basic Science (Interferon Gamma and MHC Expression) | Post-treatment | 6.125 | Full Range 0.0 to 10.5 | percentage of MHC Class II on tumor cell |
| Changes in Immune Response | Basic Science (Interferon Gamma and MHC Expression) | Pre-treatment | 0.14 | Full Range 0.015 to 1.05 | percentage of T cells |
| Changes in Immune Response | Basic Science (Interferon Gamma and MHC Expression) | Post-treatment | 0.82 | Full Range 0.074 to 3.39 | percentage of T cells |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Basic Science (Interferon Gamma and MHC Expression) | 8 | |
| Overall Study | COMPLETED | Basic Science (Interferon Gamma and MHC Expression) | 7 | |
| Overall Study | NOT COMPLETED | Basic Science (Interferon Gamma and MHC Expression) | 1 |
Source ClinicalTrials.gov
Adverse events21
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Flu-like symptoms | General disorders | Basic Science (Interferon Gamma and MHC Expression) | 5 | 8 | 5 |
| other | Fatigue | General disorders | Basic Science (Interferon Gamma and MHC Expression) | 5 | 8 | 5 |
| other | Chills | General disorders | Basic Science (Interferon Gamma and MHC Expression) | 4 | 8 | 4 |
| other | Headache | Nervous system disorders | Basic Science (Interferon Gamma and MHC Expression) | 4 | 8 | 4 |
| other | Fever | General disorders | Basic Science (Interferon Gamma and MHC Expression) | 2 | 8 | 2 |
| other | Body Aches | Musculoskeletal and connective tissue disorders | Basic Science (Interferon Gamma and MHC Expression) | 2 | 8 | 2 |
| other | Injection site pain | General disorders | Basic Science (Interferon Gamma and MHC Expression) | 2 | 8 | 2 |
| other | Dizziness | Nervous system disorders | Basic Science (Interferon Gamma and MHC Expression) | 1 | 8 | 1 |
| other | Insomnia | Psychiatric disorders | Basic Science (Interferon Gamma and MHC Expression) | 1 | 8 | 1 |
| other | Night Sweats | General disorders | Basic Science (Interferon Gamma and MHC Expression) | 1 | 8 | 1 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Basic Science (Interferon Gamma and MHC Expression) | 7 | 8 |
| Total, other adverse events | Basic Science (Interferon Gamma and MHC Expression) | 8 | 8 |
| Total, serious adverse events | Basic Science (Interferon Gamma and MHC Expression) | 0 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32269142 | DERIVED |
Source PubMed
Grants3
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| K12CA076930 | Career Development in Pediatric and Medical Oncology | MESHINCHI, SOHEIL; DAVIDSON, NANCY ELLEN | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1997 to 2025 | NIH RePORTER |
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| K23CA175167 | Adoptive T cell Therapy for Patients with NY-ESO-1 Expressing Sarcomas | POLLACK, SETH M | FRED HUTCHINSON CANCER RESEARCH CENTER | NATIONAL CANCER INSTITUTE | 2013 to 2017 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01957709
GET https://conductscience.org/api/trials/v1/NCT01957709/events?page=2