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Effect of Proactive Management of Side Effects on Treatment Compliance in Malignant Melanoma Patients on High-dose Intron A Therapy (Study P04600)

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ClinicalTrials.gov Identifier: NCT00723710
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : October 28, 2013
Last Update Posted : August 26, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Melanoma
Intervention Biological: Intron A (interferon alfa-2b; SCH 30500)
Enrollment 299
Recruitment Details  
Pre-assignment Details 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).
Arm/Group Title Intron A
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 294
Completed 120
Not Completed 174
Reason Not Completed
Disease progression             48
Adverse Event             88
Withdrawal by Subject             36
Physician Decision             2
Arm/Group Title Intron A
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 294
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 294 participants
52
(19 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 294 participants
Female
124
  42.2%
Male
170
  57.8%
1.Primary Outcome
Title Number of Participants Who Completed Treatment
Hide Description Treatment completion was defined as those who completed both the induction and maintenance phases.
Time Frame Up to 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants who started the induction phase
Arm/Group Title Intron A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 294
Measure Type: Number
Unit of Measure: Participants
120
Time Frame [Not Specified]
Adverse Event Reporting Description Population was all enrolled participants (299).
 
Arm/Group Title Intron-A
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Intron-A
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intron-A
Affected / at Risk (%) # Events
Total   21/299 (7.02%)    
Blood and lymphatic system disorders   
FEBRILE NEUTROPENIA  1  1/299 (0.33%)  1
NEUTROPENIA  1  1/299 (0.33%)  1
PANCYTOPENIA  1  1/299 (0.33%)  1
Cardiac disorders   
ATRIAL FIBRILLATION  1  1/299 (0.33%)  1
Eye disorders   
VISUAL IMPAIRMENT  1  1/299 (0.33%)  1
Gastrointestinal disorders   
ABDOMINAL PAIN  1  1/299 (0.33%)  1
CONSTIPATION  1  1/299 (0.33%)  1
NAUSEA  1  2/299 (0.67%)  2
VOMITING  1  2/299 (0.67%)  2
General disorders   
CHILLS  1  1/299 (0.33%)  1
FATIGUE  1  1/299 (0.33%)  1
INFUSION SITE SWELLING  1  1/299 (0.33%)  1
PYREXIA  1  1/299 (0.33%)  1
Hepatobiliary disorders   
CHOLECYSTITIS  1  1/299 (0.33%)  1
Infections and infestations   
CELLULITIS  1  2/299 (0.67%)  2
GROIN ABSCESS  1  1/299 (0.33%)  1
PNEUMONIA  1  1/299 (0.33%)  1
SINUSITIS  1  1/299 (0.33%)  1
Injury, poisoning and procedural complications   
SEROMA  1  1/299 (0.33%)  1
Musculoskeletal and connective tissue disorders   
MYALGIA  1  2/299 (0.67%)  2
PRIMARY SEQUESTRUM  1  1/299 (0.33%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
FEMALE REPRODUCTIVE NEOPLASM  1  1/299 (0.33%)  1
METASTASES TO CENTRAL NERVOUS SYSTEM  1  2/299 (0.67%)  2
Nervous system disorders   
DIZZINESS  1  1/299 (0.33%)  1
GRAND MAL CONVULSION  1  1/299 (0.33%)  1
HEADACHE  1  3/299 (1.00%)  3
Psychiatric disorders   
CONFUSIONAL STATE  1  1/299 (0.33%)  1
DEPRESSION  1  1/299 (0.33%)  1
OBSESSIVE-COMPULSIVE DISORDER  1  1/299 (0.33%)  1
Respiratory, thoracic and mediastinal disorders   
OROPHARYNGEAL PAIN  1  1/299 (0.33%)  1
THROAT TIGHTNESS  1  1/299 (0.33%)  1
Vascular disorders   
DEEP VEIN THROMBOSIS  1  1/299 (0.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intron-A
Affected / at Risk (%) # Events
Total   297/299 (99.33%)    
Blood and lymphatic system disorders   
NEUTROPENIA  1  69/299 (23.08%)  114
Gastrointestinal disorders   
CONSTIPATION  1  32/299 (10.70%)  37
DIARRHOEA  1  60/299 (20.07%)  81
DRY MOUTH  1  18/299 (6.02%)  21
DYSPEPSIA  1  18/299 (6.02%)  19
NAUSEA  1  159/299 (53.18%)  224
VOMITING  1  68/299 (22.74%)  88
General disorders   
ASTHENIA  1  17/299 (5.69%)  23
CHILLS  1  35/299 (11.71%)  56
FATIGUE  1  189/299 (63.21%)  275
INFLUENZA LIKE ILLNESS  1  220/299 (73.58%)  256
PYREXIA  1  86/299 (28.76%)  103
Investigations   
LIVER FUNCTION TEST ABNORMAL  1  117/299 (39.13%)  155
WEIGHT DECREASED  1  26/299 (8.70%)  29
Metabolism and nutrition disorders   
DECREASED APPETITE  1  80/299 (26.76%)  105
Musculoskeletal and connective tissue disorders   
MYALGIA  1  84/299 (28.09%)  102
Nervous system disorders   
DIZZINESS  1  18/299 (6.02%)  24
DYSGEUSIA  1  50/299 (16.72%)  60
HEADACHE  1  145/299 (48.49%)  215
Psychiatric disorders   
ANXIETY  1  20/299 (6.69%)  22
DEPRESSION  1  97/299 (32.44%)  102
INSOMNIA  1  28/299 (9.36%)  36
Respiratory, thoracic and mediastinal disorders   
COUGH  1  33/299 (11.04%)  41
DYSPNOEA  1  21/299 (7.02%)  22
Skin and subcutaneous tissue disorders   
ALOPECIA  1  29/299 (9.70%)  29
PRURITUS  1  19/299 (6.35%)  20
RASH  1  36/299 (12.04%)  43
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00723710     History of Changes
Other Study ID Numbers: P04600
First Submitted: July 25, 2008
First Posted: July 29, 2008
Results First Submitted: August 21, 2013
Results First Posted: October 28, 2013
Last Update Posted: August 26, 2015