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

Renal Cell Carcinoma Clinical Trial

Official title:

Extension Protocol for Patients With Chronic Myelogenous Leukemia (CML), Malignant Melanoma (MM) or Renal Cell Carcinoma (RCC) That Have Responded to Treatment With Pegylated-interferon α-2a (PEG-IFN) or Roferon-A in Prior Clinical Studies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02829775
• Other study ID #: NO17754
• Secondary ID: 2004-002093-30
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 6, 2016
• Last updated: July 7, 2016
• Start date: January 2004
• Est. completion date: January 2008

Study information

• Verified date: July 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• Chronic Myelogenous Leukemia (CML) participants must have a confirmed cytogenetic complete response within 2 months of entering the extension study. Malignant Melanoma (MM) and Renal Cell Carcinoma (RCC) participants must have tumour assessments verifying stable or better response within 2 months of entering the extension study

Exclusion Criteria:

• Pregnant or lactating women

• Refusal to use adequate contraceptive measures among men and women of childbearing potential

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Chronic Myelogenous Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Malignant Melanoma
• Melanoma
• Renal Cell Carcinoma

Intervention

Drug:
• Pegylated Interferon Alfa-2a
Participants will maintain the same dose they were receiving in the parent protocol.
• Recombinant Interferon Alfa 2a
Participants will maintain the same dose they were receiving in the parent protocol.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Bulgaria,  Canada,  India,  Russian Federation,  Slovakia,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Serious Adverse Events		up to approximately 3 years	No
Secondary	Number of Participants with Overall Tumor Response		Baseline until disease progression or death, whichever occured earlier (assessed every 6 months up to approximately 3 years)	No