Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the compliance with and perceptions of treatment, as well as health-related quality of life (HRQOL) in surgically resected melanoma patients undergoing HDI or PEG IFN therapy.
The primary objective of this study is:
• To evaluate compliance with the administration of standard HDI versus PEG IFN for patients with melanoma in need of adjuvant therapy
The secondary objectives of this study are:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intron A, HDI | High-dose interferon alfa (Intron A, HDI) | ||
| Sylatron | Pegylated alfa-interferon 2b (Sylatron, PEG IFN) |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Compliance With Standard High Dose Interferon (HDI) Versus Sylatron | To evaluate compliance with administration of standard HDI versus PEG IFN for patients with surgically resected melanoma in need of adjuvant therapy | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with surgically resected melanoma receiving adjuvant therapy with HDI or PEG IFN thherapy
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Neil Belman, DO | St. Luke's Hospital and Health Network, Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffit Cancer Center | Tampa | Florida | 33612 | United States | ||
| Roswell Park Cancer Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 25, 2014 | Jul 10, 2023 |
Not provided
Not provided
Not provided
Not provided
| baseline -week 1, week 3, week 13, week 25, week 50 |
| Assess the Frequency of Grade 3 and Grade 4 Toxicities | 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 | baseline-week 1, week 3, week 13, week 25, week 50 |
| Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | 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"). | baseline-week 1, week 3, week 13, week 25, week 50 |
| Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM) | 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. | Baseline-week 1, Week 3, week 13 week 25, week 50 |
| Buffalo |
| New York |
| 14263 |
| United States |
| St Luke's University Hospital and Health Network | Bethlehem | Pennsylvania | 18015 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112-5550 | United States |
| 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) |
| Per Protocol Population Week 3 |
|
| Per Protocol Population Week 13 |
|
| Per Protocol Poulation Week 25 |
|
| Per Protocol Poulation Week 53 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluate Compliance With Standard High Dose Interferon (HDI) Versus Sylatron | To evaluate compliance with administration of standard HDI versus PEG IFN for patients with surgically resected melanoma in need of adjuvant therapy | Posted | Median | Full Range | number of doses taken | 1 year |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Compare Quality of Life (Qol)for Patients on HDI Versus PEG IFN | 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. | Posted | Median | Full Range | score on a scale | baseline -week 1, week 3, week 13, week 25, week 50 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Assess the Frequency of Grade 3 and Grade 4 Toxicities | 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 | Posted | Number | number of grade 3 and 4 adverse events | baseline-week 1, week 3, week 13, week 25, week 50 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Reason For Choice of Treatment With HDI Versus PEG IFN | 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"). | This outcome only applies to patients whose physician allowed them to choose their treatment. | Posted | Number | percentage of participants | baseline-week 1, week 3, week 13, week 25, week 50 |
| |||||||||||||||||||||||||||||||
| Secondary | Treatment-Related Side Effects Impacting Health-Related Quality of Life (FACT-BRM) | 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. | Fewer participants completed the questionnaire from baseline toward the week 50 time point | Posted | Median | Full Range | score on a scale | Baseline-week 1, Week 3, week 13 week 25, week 50 |
|
|
baseline, week 1, week 3, week 13, week 25, week 50
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 26 | 7 | 26 | 22 | 26 |
| EG001 | 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) | 0 | 24 | 3 | 24 | 2 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cholecystitis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| skin infection | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| sepsis | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| flank pain | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| renal calculi | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| thromboembolic event | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| urinary tract infection | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| alanine aminotransferase increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| anorexia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| aspartate aminotransferase | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| cardiac disorder, other | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| confusion | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| dizziness | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| fall | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
| |
| fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| fever | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| hyperglycemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| hypokalemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| lymphocyte count decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| neutrophil count decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| rash, maculopapular | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| sinus tachycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| skin infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| vertigo | Ear and labyrinth disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| weight loss | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| white blood cell count decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neil Belman | St. Luke's University Health Network | 484-503-4673 | neil.belman@sluhn.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 10, 2023 | Aug 5, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
|
|
|
| Participants |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|