Trial Outcomes & Findings for Recombinant Interferon Alfa-2b in Treating Patients With Melanoma (NCT NCT01460875)
NCT ID: NCT01460875
Last Updated: 2018-11-02
Results Overview
Mean and 95% confidence interval will be summarized for phospho-STAT1 at a lower dose and the standard dose. The phospho-STAT1 will also be compared between the dose levels.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
up to 4 weeks
Results posted on
2018-11-02
Participant Flow
Participant milestones
| Measure |
Treatment (Interferon Therapy)
Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.
recombinant interferon alfa-2b: Given SC
laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.
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|---|---|
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Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
34
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Recombinant Interferon Alfa-2b in Treating Patients With Melanoma
Baseline characteristics by cohort
| Measure |
Treatment (Interferon Therapy)
n=34 Participants
Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.
recombinant interferon alfa-2b: Given SC
laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.
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|---|---|
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Age, Continuous
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52 years
n=5 Participants
|
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Sex: Female, Male
Female
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16 Participants
n=5 Participants
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Sex: Female, Male
Male
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18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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33 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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34 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: up to 4 weeksMean and 95% confidence interval will be summarized for phospho-STAT1 at a lower dose and the standard dose. The phospho-STAT1 will also be compared between the dose levels.
Outcome measures
| Measure |
Treatment (Interferon Therapy)
n=34 Participants
Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.
recombinant interferon alfa-2b: Given SC
laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.
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|---|---|
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Level of Activated STAT1(Phospho-STAT1)
Dose I (10 MU/m2)
|
5.96 MU/m2
Interval 0.31 to 19.1
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|
Level of Activated STAT1(Phospho-STAT1)
Dose II (4 MU/m2)
|
4.80 MU/m2
Interval 0.11 to 21.17
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SECONDARY outcome
Timeframe: up to 1 yearDetermine the tolerability of adjuvant IFN-α-2b administered at an optimized dose in terms of the toxicities that are observed and the ability of patients to receive a full year of therapy.
Outcome measures
| Measure |
Treatment (Interferon Therapy)
n=34 Participants
Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.
recombinant interferon alfa-2b: Given SC
laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.
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|---|---|
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Number of Patients With Adverse Events
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15 Participants
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SECONDARY outcome
Timeframe: Prior to treatment and 1 and 4 hours post therapy on day 1 every other week during the first 12 weeks, and then every 3 monthsLevels of p-STAT1 in PBMCs were analyzed just prior to IFN-a-2b administration to determine levels that remained stable or increased over the course of dose reduction.
Outcome measures
| Measure |
Treatment (Interferon Therapy)
n=34 Participants
Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.
recombinant interferon alfa-2b: Given SC
laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.
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|---|---|
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Percentage of Patients With Correlation Between STAT1 Phosphorylation and Interferon Alfa Gene Regulation
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71 percentage of patients
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SECONDARY outcome
Timeframe: 1 hour post therapyEvaluated using microarray analysis of patient PBMCs. Compared using the Wilcoxon signed rank test for the dose 10MU/m2
Outcome measures
| Measure |
Treatment (Interferon Therapy)
n=23 Participants
Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.
recombinant interferon alfa-2b: Given SC
laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.
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|---|---|
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Effect of Dose-reduction on Expression of Interferon Alfa Stimulated Genes
SOCS1-1 hour post 10MU-
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1.5 fold change
Interval 0.6 to 6.2
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|
Effect of Dose-reduction on Expression of Interferon Alfa Stimulated Genes
OAS1-1 hour post 10MU-
|
1.6 fold change
Interval 0.5 to 24.8
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|
Effect of Dose-reduction on Expression of Interferon Alfa Stimulated Genes
CXCL10-1 hour post 10MU
|
28.7 fold change
Interval 0.2 to 5128.0
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Effect of Dose-reduction on Expression of Interferon Alfa Stimulated Genes
CD69-1 hour post 10MU
|
1.3 fold change
Interval 0.4 to 12.1
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SECONDARY outcome
Timeframe: 1 hour post therapyEvaluated using microarray analysis of patient PBMCs. Compared using the Wilcoxon signed rank test for the dose 4MU/m2
Outcome measures
| Measure |
Treatment (Interferon Therapy)
n=23 Participants
Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.
recombinant interferon alfa-2b: Given SC
laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.
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|---|---|
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Effect of Dose-reduction on Interferon Alfa Gene Expression
CD69-1 hour post 4MU
|
1.3 fold increase
Interval 0.4 to 2.1
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Effect of Dose-reduction on Interferon Alfa Gene Expression
SOCS1-1 hour post 4MU
|
1.2 fold increase
Interval 0.4 to 17.7
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Effect of Dose-reduction on Interferon Alfa Gene Expression
OAS1-1 hour post 4MU
|
1.6 fold increase
Interval 0.5 to 5.1
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Effect of Dose-reduction on Interferon Alfa Gene Expression
CXCL10-1 hour post 4MU
|
6.0 fold increase
Interval 0.0 to 386.4
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SECONDARY outcome
Timeframe: 4 hours post therapyEvaluated using microarray analysis of patient PBMCs. Compared between doses using the Wilcoxon signed rank test.
Outcome measures
| Measure |
Treatment (Interferon Therapy)
n=22 Participants
Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.
recombinant interferon alfa-2b: Given SC
laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.
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|---|---|
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Effect of Dose-reduction on Interferon Alfa Gene Expression Through Marker CD69
SOCS1- 4 hour post-10MU
|
1.5 fold increase
Interval 0.6 to 6.2
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Effect of Dose-reduction on Interferon Alfa Gene Expression Through Marker CD69
OAS1-4 hour post -10MU
|
1.6 fold increase
Interval 0.5 to 24.8
|
|
Effect of Dose-reduction on Interferon Alfa Gene Expression Through Marker CD69
CXCL10-4 hour post- 10MU
|
28.7 fold increase
Interval 0.2 to 5128.0
|
|
Effect of Dose-reduction on Interferon Alfa Gene Expression Through Marker CD69
CD69-4 hour post- 10MU
|
1.3 fold increase
Interval 0.4 to 12.1
|
SECONDARY outcome
Timeframe: 4 hours post therapyEvaluated using microarray analysis of patient PBMCs. Compared between doses using the Wilcoxon signed rank test.
Outcome measures
| Measure |
Treatment (Interferon Therapy)
n=23 Participants
Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.
recombinant interferon alfa-2b: Given SC
laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.
|
|---|---|
|
Effect of Dose-reduction on Interferon Alfa Gene Expression at Dose Level 4MU
SOCS1-4 hour post 4MU-
|
1.6 fold increase
Interval 0.4 to 8.8
|
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Effect of Dose-reduction on Interferon Alfa Gene Expression at Dose Level 4MU
OAS1-4 hour post 4MU
|
3.9 fold increase
Interval 0.4 to 19.1
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Effect of Dose-reduction on Interferon Alfa Gene Expression at Dose Level 4MU
CXCL10-4 hour post 4MU
|
112.9 fold increase
Interval 0.0 to 2898.0
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Effect of Dose-reduction on Interferon Alfa Gene Expression at Dose Level 4MU
CD69-4 hour post 4MU
|
1.5 fold increase
Interval 0.4 to 4.5
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SECONDARY outcome
Timeframe: Baseline and every other week prior to recombinant interferon alfa-2b administrationPopulation: Data was not collected and analyzed for outcome measure
Define the clinical role of tumor sensitivity to IFN-α, patient tumor biopsies taken prior to the administration of IFN-α will be systematically evaluated for cellular levels of Jak-STAT signaling intermediates.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Interferon Therapy)
Serious events: 22 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Interferon Therapy)
n=34 participants at risk
Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.
recombinant interferon alfa-2b: Given SC
laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.
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|---|---|
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Gastrointestinal disorders
Nausea
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2.9%
1/34 • Number of events 1
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General disorders
Fatigue
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14.7%
5/34 • Number of events 5
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Blood and lymphatic system disorders
Myelosuppression
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20.6%
7/34 • Number of events 7
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Investigations
Increased AST
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5.9%
2/34 • Number of events 2
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Psychiatric disorders
Neuropsychiatric Systems
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5.9%
2/34 • Number of events 2
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Metabolism and nutrition disorders
Electrolyte Abnormalities
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14.7%
5/34 • Number of events 5
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Other adverse events
| Measure |
Treatment (Interferon Therapy)
n=34 participants at risk
Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.
recombinant interferon alfa-2b: Given SC
laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.
|
|---|---|
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General disorders
Fever
|
23.5%
8/34 • Number of events 8
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Musculoskeletal and connective tissue disorders
Myalgia
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82.4%
28/34 • Number of events 28
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Gastrointestinal disorders
Nausea
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47.1%
16/34 • Number of events 16
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Gastrointestinal disorders
Vomiting
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23.5%
8/34 • Number of events 8
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General disorders
Fatigue
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82.4%
28/34 • Number of events 28
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Blood and lymphatic system disorders
Mylosuppression
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79.4%
27/34 • Number of events 27
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Investigations
Increased AST
|
55.9%
19/34 • Number of events 19
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Psychiatric disorders
Neuropsychiatric Symptoms
|
35.3%
12/34 • Number of events 12
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General disorders
Rigors/Chills
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55.9%
19/34 • Number of events 19
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Gastrointestinal disorders
Diarrhea
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26.5%
9/34 • Number of events 9
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Metabolism and nutrition disorders
Electrolyte Abnormalities
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67.6%
23/34 • Number of events 23
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Metabolism and nutrition disorders
Hyperglycemia
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29.4%
10/34 • Number of events 10
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Skin and subcutaneous tissue disorders
Alopecia
|
29.4%
10/34 • Number of events 10
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Additional Information
William Carson, MD
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-6306
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place