Trial Outcomes & Findings for A Study to Compare Quality of Life and Compliance in Patients Receiving High-dose Interferon Versus Pegylated Interferon in Patients With Surgically Resected Melanoma (NCT NCT01986712)

NCT ID: NCT01986712

Last Updated: 2025-02-13

Results Overview

To evaluate compliance with administration of standard HDI versus PEG IFN for patients with surgically resected melanoma in need of adjuvant therapy

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

1 year

Results posted on

2025-02-13

Participant Flow

From December 2013 to December 2017, physicians at four medical centers referred and enrolled participants to this non-randomized, observational, phase IV, multi-site pilot study. The first subject was enrolled in December 2013 and the last subject was enrolled in December 2017.

After discussion with their treating physician, patients were to receive 1 of 2 approved adjuvant therapies for melanoma: either high-dose interferon alfa (HDI, Intron® A)\[Cohort A, arm 1\] or pegylated alfa-interferon 2b (PEG IFN, Sylatron™)\[Cohort B, arm 2\]. On this observational study, 50 subjects were included in the analysis: 26 subjects on arm 1 and 24 on arm 2.

Participant milestones

Participant milestones
Measure	Arm 1/High-dose Interferon Alfa (Intron A, HDI) Induction: 20 million IU/m2 high dose interferon (HDI) as an intravenous (IV) infusion over 20 minutes, 5 consecutive days per week for 4 weeks. Maintenance: 10 million IU/m2 high dose interferon (HDI)as an subcutaneous (SC) injection 3 times per week for 48 weeks	Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) Induction: 6 mcg/kg/week Pegylated Interferon (Sylatraon)subcutaneous (SC) for 8 doses. Maintenance: 3 mcg/kg/week Pegylated Interferon (Sylatraon) SC for up to 5 years (only the first year of therapy will be evaluated in this study)
Overall Study STARTED	26	24
Overall Study Per Protocol Population Week 3	20	12
Overall Study Per Protocol Population Week 13	11	13
Overall Study Per Protocol Poulation Week 25	8	14
Overall Study Per Protocol Poulation Week 53	1	8
Overall Study COMPLETED	1	8
Overall Study NOT COMPLETED	25	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1/High-dose Interferon Alfa (Intron A, HDI) n=26 Participants Induction: 20 million IU/m2 high dose interferon (HDI) as an intravenous (IV) infusion over 20 minutes, 5 consecutive days per week for 4 weeks. Maintenance: 10 million IU/m2 high dose interferon (HDI)as an subcutaneous (SC) injection 3 times per week for 48 weeks	Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) n=24 Participants Induction: 6 mcg/kg/week Pegylated Interferon (Sylatraon)subcutaneous (SC) for 8 doses. Maintenance: 3 mcg/kg/week Pegylated Interferon (Sylatraon) SC for up to 5 years (only the first year of therapy will be evaluated in this study)	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=26 Participants	0 Participants n=24 Participants	0 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=26 Participants	17 Participants n=24 Participants	35 Participants n=50 Participants
Age, Categorical >=65 years	8 Participants n=26 Participants	7 Participants n=24 Participants	15 Participants n=50 Participants
Sex: Female, Male Female	9 Participants n=26 Participants	6 Participants n=24 Participants	15 Participants n=50 Participants
Sex: Female, Male Male	17 Participants n=26 Participants	18 Participants n=24 Participants	35 Participants n=50 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	26 Participants n=26 Participants	24 Participants n=24 Participants	50 Participants n=50 Participants

PRIMARY outcome

Timeframe: 1 year

To evaluate compliance with administration of standard HDI versus PEG IFN for patients with surgically resected melanoma in need of adjuvant therapy

Outcome measures

Outcome measures
Measure	Arm 1/High-dose Interferon Alfa (Intron A, HDI) n=26 Participants Induction: 20 million IU/m2 high dose interferon (HDI) as an intravenous (IV) infusion over 20 minutes, 5 consecutive days per week for 4 weeks. Maintenance: 10 million IU/m2 high dose interferon (HDI)as an subcutaneous (SC) injection 3 times per week for 48 weeks	Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) n=24 Participants Induction: 6 mcg/kg/week Pegylated Interferon (Sylatraon)subcutaneous (SC) for 8 doses. Maintenance: 3 mcg/kg/week Pegylated Interferon (Sylatraon) SC for up to 5 years (only the first year of therapy will be evaluated in this study)
Evaluate Compliance With Standard High Dose Interferon (HDI) Versus Sylatron	10 number of doses taken Interval 2.0 to 51.0	38 number of doses taken Interval 1.0 to 52.0

SECONDARY outcome

Timeframe: baseline -week 1, week 3, week 13, week 25, week 50

To compare QOL for patients on standard HDI versus PEG IFN using chemotherapy convenience and satisfaction questionnaire (CCSQ). The CCSQ measures the construct "chemotherapy convenience and satisfaction" and includes 10 questions \[scores from 0 ("not at all") to 4 ("very much"), maximum possible summative score = 40\]. Higher scores signify a better outcome. Minimum possible summative score = 0.

Outcome measures

Outcome measures
Measure	Arm 1/High-dose Interferon Alfa (Intron A, HDI) n=26 Participants Induction: 20 million IU/m2 high dose interferon (HDI) as an intravenous (IV) infusion over 20 minutes, 5 consecutive days per week for 4 weeks. Maintenance: 10 million IU/m2 high dose interferon (HDI)as an subcutaneous (SC) injection 3 times per week for 48 weeks	Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) n=24 Participants Induction: 6 mcg/kg/week Pegylated Interferon (Sylatraon)subcutaneous (SC) for 8 doses. Maintenance: 3 mcg/kg/week Pegylated Interferon (Sylatraon) SC for up to 5 years (only the first year of therapy will be evaluated in this study)
Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN Baseline-week 1	9 score on a scale Interval 4.0 to 24.0	4 score on a scale Interval 0.0 to 18.0
Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN week 3	18 score on a scale Interval 5.0 to 38.0	11 score on a scale Interval 2.0 to 22.0
Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN week 13	15 score on a scale Interval 5.0 to 30.0	9 score on a scale Interval 5.0 to 16.0
Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN week 25	14 score on a scale Interval 3.0 to 28.0	8 score on a scale Interval 3.0 to 18.0
Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN week 50	12 score on a scale Interval 5.0 to 21.0	11 score on a scale Interval 2.0 to 22.0

SECONDARY outcome

Timeframe: baseline-week 1, week 3, week 13, week 25, week 50

To assess the frequency of Grade 3 and 4 toxicities, according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) for patients on standard HDI versus PEG IFN

Outcome measures

Outcome measures
Measure	Arm 1/High-dose Interferon Alfa (Intron A, HDI) n=26 Participants Induction: 20 million IU/m2 high dose interferon (HDI) as an intravenous (IV) infusion over 20 minutes, 5 consecutive days per week for 4 weeks. Maintenance: 10 million IU/m2 high dose interferon (HDI)as an subcutaneous (SC) injection 3 times per week for 48 weeks	Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) n=24 Participants Induction: 6 mcg/kg/week Pegylated Interferon (Sylatraon)subcutaneous (SC) for 8 doses. Maintenance: 3 mcg/kg/week Pegylated Interferon (Sylatraon) SC for up to 5 years (only the first year of therapy will be evaluated in this study)
Assess the Frequency of Grade 3 and Grade 4 Toxicities	74 number of grade 3 and 4 adverse events	5 number of grade 3 and 4 adverse events

SECONDARY outcome

Timeframe: baseline-week 1, week 3, week 13, week 25, week 50

Population: This outcome only applies to patients whose physician allowed them to choose their treatment.

To examine reasons for patients' choice of treatment HDI versus PEG IFN, for those cases in which patients are presented with a choice of either treatment option (percentage answering "very important", "somewhat important", or "not important" for "frequency", "toxicity", "effectiveness", "convenience", and "length").

Outcome measures

Outcome measures
Measure	Arm 1/High-dose Interferon Alfa (Intron A, HDI) n=26 Participants Induction: 20 million IU/m2 high dose interferon (HDI) as an intravenous (IV) infusion over 20 minutes, 5 consecutive days per week for 4 weeks. Maintenance: 10 million IU/m2 high dose interferon (HDI)as an subcutaneous (SC) injection 3 times per week for 48 weeks	Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) n=24 Participants Induction: 6 mcg/kg/week Pegylated Interferon (Sylatraon)subcutaneous (SC) for 8 doses. Maintenance: 3 mcg/kg/week Pegylated Interferon (Sylatraon) SC for up to 5 years (only the first year of therapy will be evaluated in this study)
Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN percentage of choice by frequency-very important	72.9 percentage of participants	71.4 percentage of participants
Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN percentage of choice by frequency:somewhat important	18.2 percentage of participants	28.6 percentage of participants
Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN percentage of choice by frequency: not important	9.1 percentage of participants	0.0 percentage of participants
Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN percentage of choice by toxicity-very important	54.5 percentage of participants	85.7 percentage of participants
Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN percentage of choice by toxicity-somewhat important	36.4 percentage of participants	14.3 percentage of participants
Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN percentage of choice by toxicity-not important	9.1 percentage of participants	0 percentage of participants
Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN percentage of choice by effectiveness-very important	100 percentage of participants	100 percentage of participants
Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN percentage of choice by convenience-very important	45.5 percentage of participants	71.4 percentage of participants
Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN percentage of choice by convenience-somewhat important	45.5 percentage of participants	28.6 percentage of participants
Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN percentage of choice by convenience-not important	9.1 percentage of participants	0 percentage of participants
Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN percentage of choice by length-very important	45.5 percentage of participants	64.3 percentage of participants
Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN percentage of choice by length-not important	9.1 percentage of participants	14.3 percentage of participants
Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN percentage of choice by length-somewhat important	45.5 percentage of participants	21.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline-week 1, Week 3, week 13 week 25, week 50

Population: Fewer participants completed the questionnaire from baseline toward the week 50 time point

To compare QOL for patients on standard HDI versus PEG IFN using the Functional Assessment of Cancer Therapy - biologic response modifier, questionnaire (FACT-BRM). The FACT-BRM measures the construct "Functional Assessment of Cancer Therapy" and includes 40 questions \[scores from 0 ("not at all") to 4 ("very much"), maximum possible summative score = 160\]. Due to the nature of their items, the Social/Family Well-Being and Functional Well-Being subscale scores were reverse coded. For the summative score, higher scores signify a worse outcome. Minimum possible summative score = 0.

Outcome measures

Outcome measures
Measure	Arm 1/High-dose Interferon Alfa (Intron A, HDI) n=26 Participants Induction: 20 million IU/m2 high dose interferon (HDI) as an intravenous (IV) infusion over 20 minutes, 5 consecutive days per week for 4 weeks. Maintenance: 10 million IU/m2 high dose interferon (HDI)as an subcutaneous (SC) injection 3 times per week for 48 weeks	Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) n=24 Participants Induction: 6 mcg/kg/week Pegylated Interferon (Sylatraon)subcutaneous (SC) for 8 doses. Maintenance: 3 mcg/kg/week Pegylated Interferon (Sylatraon) SC for up to 5 years (only the first year of therapy will be evaluated in this study)
Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM) Baseline-week 1	28.5 score on a scale Interval 1.0 to 58.0	21 score on a scale Interval 5.0 to 68.0
Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM) week 3	60.5 score on a scale Interval 7.0 to 92.0	46.5 score on a scale Interval 16.0 to 96.0
Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM) week 13	57 score on a scale Interval 16.0 to 87.0	48 score on a scale Interval 17.0 to 84.0
Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM) week 25	53 score on a scale Interval 19.0 to 91.0	49 score on a scale Interval 31.0 to 88.0
Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM) week 50	56 score on a scale Interval 20.0 to 74.0	51.5 score on a scale Interval 19.0 to 74.0

Adverse Events

Arm 1/High-dose Interferon Alfa (Intron A, HDI)

Serious events: 7 serious events

Other events: 22 other events

Deaths: 0 deaths

Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN)

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1/High-dose Interferon Alfa (Intron A, HDI) n=26 participants at risk Induction: 20 million IU/m2 high dose interferon (HDI) as an intravenous (IV) infusion over 20 minutes, 5 consecutive days per week for 4 weeks. Maintenance: 10 million IU/m2 high dose interferon (HDI)as an subcutaneous (SC) injection 3 times per week for 48 weeks	Arm 2/Pegylated Alfa-interferon 2b (Sylatron, PEG IFN) n=24 participants at risk Induction: 6 mcg/kg/week Pegylated Interferon (Sylatraon)subcutaneous (SC) for 8 doses. Maintenance: 3 mcg/kg/week Pegylated Interferon (Sylatraon) SC for up to 5 years (only the first year of therapy will be evaluated in this study)
Hepatobiliary disorders cholecystitis	7.7% 2/26 • Number of events 2 • baseline, week 1, week 3, week 13, week 25, week 50	0.00% 0/24 • baseline, week 1, week 3, week 13, week 25, week 50
Gastrointestinal disorders abdominal pain	3.8% 1/26 • Number of events 1 • baseline, week 1, week 3, week 13, week 25, week 50	0.00% 0/24 • baseline, week 1, week 3, week 13, week 25, week 50
General disorders Fatigue	3.8% 1/26 • Number of events 1 • baseline, week 1, week 3, week 13, week 25, week 50	0.00% 0/24 • baseline, week 1, week 3, week 13, week 25, week 50
Skin and subcutaneous tissue disorders skin infection	3.8% 1/26 • Number of events 1 • baseline, week 1, week 3, week 13, week 25, week 50	8.3% 2/24 • Number of events 2 • baseline, week 1, week 3, week 13, week 25, week 50
Blood and lymphatic system disorders sepsis	3.8% 1/26 • Number of events 1 • baseline, week 1, week 3, week 13, week 25, week 50	0.00% 0/24 • baseline, week 1, week 3, week 13, week 25, week 50
Gastrointestinal disorders nausea	3.8% 1/26 • Number of events 1 • baseline, week 1, week 3, week 13, week 25, week 50	0.00% 0/24 • baseline, week 1, week 3, week 13, week 25, week 50
Gastrointestinal disorders vomiting	3.8% 1/26 • Number of events 1 • baseline, week 1, week 3, week 13, week 25, week 50	0.00% 0/24 • baseline, week 1, week 3, week 13, week 25, week 50
Renal and urinary disorders flank pain	3.8% 1/26 • Number of events 1 • baseline, week 1, week 3, week 13, week 25, week 50	0.00% 0/24 • baseline, week 1, week 3, week 13, week 25, week 50
Renal and urinary disorders renal calculi	3.8% 1/26 • Number of events 1 • baseline, week 1, week 3, week 13, week 25, week 50	0.00% 0/24 • baseline, week 1, week 3, week 13, week 25, week 50
Nervous system disorders thromboembolic event	3.8% 1/26 • Number of events 1 • baseline, week 1, week 3, week 13, week 25, week 50	0.00% 0/24 • baseline, week 1, week 3, week 13, week 25, week 50
Gastrointestinal disorders diarrhea	3.8% 1/26 • Number of events 1 • baseline, week 1, week 3, week 13, week 25, week 50	0.00% 0/24 • baseline, week 1, week 3, week 13, week 25, week 50
Renal and urinary disorders urinary tract infection	0.00% 0/26 • baseline, week 1, week 3, week 13, week 25, week 50	4.2% 1/24 • Number of events 1 • baseline, week 1, week 3, week 13, week 25, week 50

Other adverse events

Additional Information

Neil Belman

St. Luke's University Health Network

Phone: 484-503-4673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place