Overview

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

Status:
Completed

Trial end date:
2001-03-16

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Merck Sharp & Dohme Corp.

Treatments:

Acetaminophen
Interferon alpha-2
Interferon-alpha
Interferons
Peginterferon alfa-2b

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.