A Study of Continued Treatment Among Participants Who Have Responded to Peginterferon Alfa-2a (Pegasys®) or Recombinant Interferon Alfa-2a (Roferon-A®) in Prior Clinical Studies

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2008-01-31

Brief Summary

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This open label extension study will give an opportunity to the participants that have responded to the treatment with Pegylated-Interferon Alfa-2a (Pegasys) or Recombinant Interferon Alfa-2a (Roferon-A®) in prior clinical studies NO15753 (NCT00003542) for Renal Cell Carcinoma (RCC), NO15764 (NCT number not available) and NO16006 (NCT02736721) for Chronic Myelogenous Leukemia (CML), and NO16007 (NCT number not available) for Malignant Melanoma (MM).

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Detailed Description

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Conditions

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Chronic Myelogenous Leukemia Malignant Melanoma Renal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interferon Alfa-2A in Cancer Participants

Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study will continue to receive the same treatment in this study. Pegylated interferon alfa-2A will be administered subcutaneously once weekly and recombinant interferon alfa 2A will be administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurs first (up to approximately 3 years).

Group Type EXPERIMENTAL

Pegylated Interferon Alfa-2a

Intervention Type DRUG

Participants will maintain the same dose they were receiving in the parent protocol.

Recombinant Interferon Alfa 2a

Intervention Type DRUG

Participants will maintain the same dose they were receiving in the parent protocol.

Interventions

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Pegylated Interferon Alfa-2a

Participants will maintain the same dose they were receiving in the parent protocol.

Intervention Type DRUG

Recombinant Interferon Alfa 2a

Participants will maintain the same dose they were receiving in the parent protocol.

Intervention Type DRUG

Other Intervention Names

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Pegasys Roferon-A

Eligibility Criteria

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Inclusion Criteria

* Participants must have completed protocol NO15753, NO15764, NO16006 or NO16007 and responded to treatment at the end of the trial as defined in the parent protocol
* CML participants must have a confirmed cytogenetic complete response within 2 months of entering the extension study. MM and RCC participants must have tumour assessments verifying stable or better response within 2 months of entering the extension study