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Patients with malignant melanoma who had undergone surgery will receive adjuvant treatment with high-dose Intron A for one year. The objective of this study is to maximize treatment compliance by proactive management of side effects in a day-to-day healthcare setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intron A | Patients with malignant melanoma who are free of disease post-surgery but at high risk for systemic recurrence. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intron A (interferon alfa-2b; SCH 30500) | Biological | The recommended regimen includes an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 million international units per square meter (MIU/m^2). The induction treatment should be followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m^2. Therapy should be administered for a total of one year unless the disease progresses or the treatment has lead to recurrent unmanageable serious adverse effects. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Completed Treatment | Treatment completion was defined as those who completed both the induction and maintenance phases. | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Approximately 300 patients with malignant melanoma who are free of disease but at high risk for systemic recurrence. The study is conducted in Canada.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18317583 | Result | Levesque N, Mitchinson K, Lawrie D, Fedorak L, Macdonald D, Normand C, Pouliot JF. Health management program: factors influencing completion of therapy with high-dose interferon alfa-2b for high-risk melanoma. Curr Oncol. 2008 Jan;15(1):36-41. doi: 10.3747/co.2008.200. |
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299 participants were enrolled. Of these, 294 were considered efficacy evaluable (5 participants were excluded from efficacy analyses: 2 moved, 1 required radiation, 1 not eligible and 1 missing data).
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| ID | Title | Description |
|---|---|---|
| FG000 | Intron A | The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 million international units per square meter (MIU/m^2). The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intron A | The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 MIU/m^2. The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | 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 | Number of Participants Who Completed Treatment | Treatment completion was defined as those who completed both the induction and maintenance phases. | The number of participants who started the induction phase | Posted | Number | Participants | Up to 1 year |
|
|
|
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Population was all enrolled participants (299).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intron-A | 21 | 299 | 297 | 299 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| VISUAL IMPAIRMENT | Eye disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INFUSION SITE SWELLING | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| GROIN ABSCESS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| SEROMA | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PRIMARY SEQUESTRUM | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| FEMALE REPRODUCTIVE NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| METASTASES TO CENTRAL NERVOUS SYSTEM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| GRAND MAL CONVULSION | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| OBSESSIVE-COMPULSIVE DISORDER | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| THROAT TIGHTNESS | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| 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 |
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| ID | Term |
|---|---|
| D007438 | Introns |
| D000077190 | Interferon alpha-2 |
| ID | Term |
|---|---|
| D021901 | DNA, Intergenic |
| D040481 | Genome Components |
| D016678 | Genome |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D040461 | Gene Components |
| D005796 | Genes |
| D016898 | Interferon-alpha |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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