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

Open-Label Extended Administration of SCH 54031 (PEG Interferon Alfa-2b/PEG Intron) in Subjects With Solid Tumors

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Drug: PEG Interferon Alfa-2b; Drug: Acetaminophen

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / 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: SCH 54031; MK-4031; 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 Names: 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: SCH 54031; MK-4031; 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 Names: 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: SCH 54031; MK-4031; 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 Names: 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: SCH 54031; MK-4031; 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 Names: 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: SCH 54031; MK-4031; 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 Names: 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: SCH 54031; MK-4031; 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 Names: Tylenol®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experienced an Adverse Event	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.	Up to 42 Weeks
Number of Participants Who Discontinued Treatment Due to an Adverse Event	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.	Up to 40 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Objective Response	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.	Up to 40 Weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 1997
• Primary Completion (Actual): March 16, 2001
• Study Completion (Actual): March 16, 2001

Study Registration Dates

• First Submitted: May 31, 2018
• First Submitted That Met QC Criteria: May 31, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Actual): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 12, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Antineoplastic Agents; Immunologic Factors; Interferons; Interferon-alpha; Interferon alpha-2; Acetaminophen; Peginterferon alfa-2b
• Other Study ID Numbers: C97349; MK-4031-009 (Other Identifier: Merck Protocol Number); C/l97-349 (Other Identifier: Schering-Plough Protocol Number)