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Extended Administration of Polyethylene Glycol (PEG) Interferon Alfa-2b in Participants With Solid Tumors (C/I97-349/MK-4031-009)

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ClinicalTrials.gov Identifier: NCT03554005
Recruitment Status : Completed
First Posted : June 12, 2018
Results First Posted : July 15, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study is an extension study to base study protocol C/I97-188 (MK-4031-006). Its primary purpose is to assess the safety and tolerability of extended administration of polyethylene glycol (PEG) interferon alfa-2b in participants with solid tumors.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: PEG Interferon Alfa-2b Drug: Acetaminophen Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Extended Administration of SCH 54031 (PEG Interferon Alfa-2b/PEG Intron) in Subjects With Solid Tumors
Actual Study Start Date : December 29, 1997
Actual Primary Completion Date : March 16, 2001
Actual Study Completion Date : March 16, 2001


Arm Intervention/treatment
Experimental: PEG Interferon Alfa-2b 0.75 mcg/kg Once Weekly (OW)
Participants receive PEG interferon alfa-2b 0.75 mcg/kg by subcutaneous (SC) injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg.
Drug: PEG Interferon Alfa-2b
Participants receive PEG interferon alfa-2b administered by SC injection, in doses ranging from 0.75 mcg/kg OW up to 7.5 mcg/kg OW, for up to 40 weeks of treatment.
Other Names:
  • MK-4031
  • SCH 54031
  • PEG Intron®

Drug: Acetaminophen
Participants receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and continue acetaminophen 500 to 1000 mg after administration every 4 to 6 hours as needed. The total daily dose of acetaminophen should not exceed 3000 mg.
Other Name: Tylenol®

Experimental: PEG Interferon Alfa-2b 1.5 mcg/kg OW
Participants receive PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg.
Drug: PEG Interferon Alfa-2b
Participants receive PEG interferon alfa-2b administered by SC injection, in doses ranging from 0.75 mcg/kg OW up to 7.5 mcg/kg OW, for up to 40 weeks of treatment.
Other Names:
  • MK-4031
  • SCH 54031
  • PEG Intron®

Drug: Acetaminophen
Participants receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and continue acetaminophen 500 to 1000 mg after administration every 4 to 6 hours as needed. The total daily dose of acetaminophen should not exceed 3000 mg.
Other Name: Tylenol®

Experimental: PEG Interferon Alfa-2b 3 mcg/kg OW
Participants receive PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg.
Drug: PEG Interferon Alfa-2b
Participants receive PEG interferon alfa-2b administered by SC injection, in doses ranging from 0.75 mcg/kg OW up to 7.5 mcg/kg OW, for up to 40 weeks of treatment.
Other Names:
  • MK-4031
  • SCH 54031
  • PEG Intron®

Drug: Acetaminophen
Participants receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and continue acetaminophen 500 to 1000 mg after administration every 4 to 6 hours as needed. The total daily dose of acetaminophen should not exceed 3000 mg.
Other Name: Tylenol®

Experimental: PEG Interferon Alfa-2b 4.5 mcg/kg OW
Participants receive PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg.
Drug: PEG Interferon Alfa-2b
Participants receive PEG interferon alfa-2b administered by SC injection, in doses ranging from 0.75 mcg/kg OW up to 7.5 mcg/kg OW, for up to 40 weeks of treatment.
Other Names:
  • MK-4031
  • SCH 54031
  • PEG Intron®

Drug: Acetaminophen
Participants receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and continue acetaminophen 500 to 1000 mg after administration every 4 to 6 hours as needed. The total daily dose of acetaminophen should not exceed 3000 mg.
Other Name: Tylenol®

Experimental: PEG Interferon Alfa-2b 6 mcg/kg OW
Participants receive PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg.
Drug: PEG Interferon Alfa-2b
Participants receive PEG interferon alfa-2b administered by SC injection, in doses ranging from 0.75 mcg/kg OW up to 7.5 mcg/kg OW, for up to 40 weeks of treatment.
Other Names:
  • MK-4031
  • SCH 54031
  • PEG Intron®

Drug: Acetaminophen
Participants receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and continue acetaminophen 500 to 1000 mg after administration every 4 to 6 hours as needed. The total daily dose of acetaminophen should not exceed 3000 mg.
Other Name: Tylenol®

Experimental: PEG Interferon Alfa-2b 7.5 mcg/kg OW
Participants receive PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg.
Drug: PEG Interferon Alfa-2b
Participants receive PEG interferon alfa-2b administered by SC injection, in doses ranging from 0.75 mcg/kg OW up to 7.5 mcg/kg OW, for up to 40 weeks of treatment.
Other Names:
  • MK-4031
  • SCH 54031
  • PEG Intron®

Drug: Acetaminophen
Participants receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and continue acetaminophen 500 to 1000 mg after administration every 4 to 6 hours as needed. The total daily dose of acetaminophen should not exceed 3000 mg.
Other Name: Tylenol®




Primary Outcome Measures :
  1. Number of Participants Who Experienced an Adverse Event [ Time Frame: Up to 42 Weeks ]
    An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  2. Number of Participants Who Discontinued Treatment Due to an Adverse Event [ Time Frame: Up to 40 Weeks ]
    An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.


Secondary Outcome Measures :
  1. Best Objective Response [ Time Frame: Up to 40 Weeks ]
    Best Objective Response data were based on World Health Organization (WHO) criteria and included four categories. Complete Response (CR) was the disappearance of all clinically detectable malignant disease. Partial Response (PR) was a decrease of ≥50% of the sum of products of largest perpendicular diameters of all bidimensionally measurable lesions; and a decrease of ≥50% in sum of largest diameters of all unidimensionally measure lesions. Stable Disease (SD) was a <50% decrease or <25% increase in sum of products of largest perpendicular diameters of all bidimensionally measurable lesions; or a <50% decrease or <25% increase in sum of diameters of all unidimensionally measurable lesions. In addition, no new lesions appeared. Progressive Disease (PD) was a ≥25% increase in size of at least one bidimensionally or unidimensionally measurable lesion or appearance of new lesion. Occurrence of pleural effusion or ascites was also considered PD if substantiated by positive cytology.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Had a response of stable disease or better in PEG interferon alfa-2b base study C/I97-188 (MK-4031-006).
  • Has a Performance Status of 0 (normal activity), 1 (symptoms, but fully ambulatory), or 2 (symptomatic, but in bed <50% of the day).
  • Is enrolled within two weeks of completing their last dose of PEG Interferon alfa-2b on the previous study and has not have received any other therapy during this period.

Exclusion Criteria:

  • Discontinued prior to completing PEG interferon alfa-2b base study C/I97-188 (MK-4031-006).
  • Is pregnant or nursing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554005


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03554005     History of Changes
Other Study ID Numbers: C97349
MK-4031-009 ( Other Identifier: Merck Protocol Number )
C/l97-349 ( Other Identifier: Schering-Plough Protocol Number )
First Posted: June 12, 2018    Key Record Dates
Results First Posted: July 15, 2019
Last Update Posted: July 15, 2019
Last Verified: July 2019

Additional relevant MeSH terms:
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Interferons
Interferon alpha-2
Interferon-alpha
Peginterferon alfa-2b
Acetaminophen
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Immunologic Factors