Trial Outcomes & Findings for Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma (NCT NCT01957709)
NCT ID: NCT01957709
Last Updated: 2019-07-10
Results Overview
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.
Recruitment status
TERMINATED
Study phase
EARLY_PHASE1
Target enrollment
8 participants
Primary outcome timeframe
Baseline to up to 2 weeks post-surgery
Results posted on
2019-07-10
Participant Flow
Recruitment was done in the Seattle Cancer Care Alliance medical clinic, or by patient referral.
Participant milestones
| Measure |
Basic Science (Interferon Gamma and MHC Expression)
Patients receive recombinant interferon gamma SC weekly for 4 weeks before surgery.
Laboratory Biomarker Analysis: Correlative studies
Recombinant Interferon Gamma: Given Subcutaneously
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Basic Science (Interferon Gamma and MHC Expression)
Patients receive recombinant interferon gamma SC weekly for 4 weeks before surgery.
Laboratory Biomarker Analysis: Correlative studies
Recombinant Interferon Gamma: Given Subcutaneously
|
|---|---|
|
Overall Study
Patient refused to complete post-tx bx
|
1
|
Baseline Characteristics
Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma
Baseline characteristics by cohort
| Measure |
Basic Science (Interferon Gamma and MHC Expression)
n=8 Participants
Patients receive recombinant interferon gamma SC every 7 days for 4 weeks before surgery or thrice weekly for 2 weeks before surgery.
Laboratory Biomarker Analysis: Correlative studies
Recombinant Interferon Gamma: Given SC
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to up to 2 weeks post-surgeryIt 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.
Outcome measures
| Measure |
Basic Science (Interferon Gamma and MHC Expression)
n=8 Participants
Patients receive recombinant interferon gamma SC every 7 days for 4 weeks before surgery or thrice weekly for 2 weeks before surgery.
Laboratory Biomarker Analysis: Correlative studies
Recombinant Interferon Gamma: Given SC
|
|---|---|
|
Change in Class I Major Histocompatibility Complex (MHC) Expression After Treatment With IFN Gamma
Pre-treatment
|
8.91 percentage of MHC Class I+ on tumor cell
Interval 0.131 to 51.6
|
|
Change in Class I Major Histocompatibility Complex (MHC) Expression After Treatment With IFN Gamma
Post-treatment
|
26.6 percentage of MHC Class I+ on tumor cell
Interval 1.39 to 92.2
|
SECONDARY outcome
Timeframe: Baseline to 2 weeks post biopsy.To determine whether systemic administration of IFNg will increase class II MHC expression in SS and MRCL tumors.
Outcome measures
| Measure |
Basic Science (Interferon Gamma and MHC Expression)
n=8 Participants
Patients receive recombinant interferon gamma SC every 7 days for 4 weeks before surgery or thrice weekly for 2 weeks before surgery.
Laboratory Biomarker Analysis: Correlative studies
Recombinant Interferon Gamma: Given SC
|
|---|---|
|
MHC Class II Expression
Pre-treatment
|
2.556 percentage of MHC Class II on tumor cell
Interval 0.0 to 6.1
|
|
MHC Class II Expression
Post-treatment
|
6.125 percentage of MHC Class II on tumor cell
Interval 0.0 to 10.5
|
SECONDARY outcome
Timeframe: Baseline to 2 weeks post biopsyTo 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.
Outcome measures
| Measure |
Basic Science (Interferon Gamma and MHC Expression)
n=8 Participants
Patients receive recombinant interferon gamma SC every 7 days for 4 weeks before surgery or thrice weekly for 2 weeks before surgery.
Laboratory Biomarker Analysis: Correlative studies
Recombinant Interferon Gamma: Given SC
|
|---|---|
|
Changes in Immune Response
Pre-treatment
|
0.14 percentage of T cells
Interval 0.015 to 1.05
|
|
Changes in Immune Response
Post-treatment
|
0.82 percentage of T cells
Interval 0.074 to 3.39
|
Adverse Events
Basic Science (Interferon Gamma and MHC Expression)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 7 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Basic Science (Interferon Gamma and MHC Expression)
n=8 participants at risk
Patients receive recombinant interferon gamma SC every 7 days for 4 weeks before surgery or thrice weekly for 2 weeks before surgery.
Laboratory Biomarker Analysis: Correlative studies
Recombinant Interferon Gamma: Given SC
|
|---|---|
|
General disorders
Flu-like symptoms
|
62.5%
5/8 • Number of events 5 • Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
|
|
General disorders
Fatigue
|
62.5%
5/8 • Number of events 5 • Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
|
|
General disorders
Chills
|
50.0%
4/8 • Number of events 4 • Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
|
|
Nervous system disorders
Headache
|
50.0%
4/8 • Number of events 4 • Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
|
|
General disorders
Fever
|
25.0%
2/8 • Number of events 2 • Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
|
|
Musculoskeletal and connective tissue disorders
Body Aches
|
25.0%
2/8 • Number of events 2 • Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
|
|
General disorders
Injection site pain
|
25.0%
2/8 • Number of events 2 • Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1 • Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
|
|
General disorders
Night Sweats
|
12.5%
1/8 • Number of events 1 • Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Number of events 1 • Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
|
|
General disorders
Malaise
|
12.5%
1/8 • Number of events 1 • Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
|
|
Nervous system disorders
Paresthesia
|
12.5%
1/8 • Number of events 1 • Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
1/8 • Number of events 1 • Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8 • Number of events 1 • Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
|
|
General disorders
Injection site erythema
|
12.5%
1/8 • Number of events 1 • Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
1/8 • Number of events 1 • Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
|
|
Infections and infestations
Upper Respiratory Infection
|
12.5%
1/8 • Number of events 1 • Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Number of events 1 • Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
|
|
Infections and infestations
Urinary Tract Infection
|
12.5%
1/8 • Number of events 1 • Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
|
|
General disorders
Biopsy site pain
|
12.5%
1/8 • Number of events 1 • Patients will be evaluated at their baseline visit prior to administration of the IFNg through two weeks following their surgery. Ideally this will be a period of 6-10 weeks, depending on the number of times a patient received IFNg subcutaneously and when their surgery was scheduled.
|
Additional Information
Seth Pollack, MD
Fred Hutchinson Cancer Research Center
Phone: 206-667-6629
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place