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

• ClinicalTrials.gov Identifier: NCT02829775
• Recruitment Status: Completed
• First Posted: July 12, 2016
• Results First Posted: November 17, 2016
• Last Update Posted: January 9, 2017
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Chronic Myelogenous Leukemia; Malignant Melanoma; Renal Cell Carcinoma	Drug: Pegylated Interferon Alfa-2a; Drug: Recombinant Interferon Alfa 2a	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Extension Protocol for Patients With Chronic Myelogenous Leukemia, Malignant Melanoma or Renal Cell Carcinoma That Have Responded to Treatment With Pegylated-Interferon α-2a or Roferon-A® in Prior Clinical Studies
• Study Start Date: January 2004
• Actual Primary Completion Date: January 2008
• Actual Study Completion Date: January 2008

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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).

Drug: Pegylated Interferon Alfa-2a; Participants will maintain the same dose they were receiving in the parent protocol.; Other Name: Pegasys; Drug: Recombinant Interferon Alfa 2a; Participants will maintain the same dose they were receiving in the parent protocol.; Other Name: Roferon-A

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Baseline up to approximately 3 years ]
   An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; Life-threatening experience (immediate risk of dying); Persistent or significant disability or incapacity; and congenital anomaly.

Secondary Outcome Measures :

1. Number of Participants With Overall Tumor Response [ Time Frame: Baseline until disease progression, withdrawal or death, whichever occurred earlier (assessed every 6 months up to approximately 3 years) ]
   Tumor response was assessed every 6 months using hematological evaluation or any other appropriate diagnostic techniques, as per standard of care practice. The complete response (CR) and partial response (PR) status were recorded from case report form.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Exclusion Criteria:

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

Contacts and Locations

Locations

Bulgaria

Sofia, Bulgaria, 1757

Canada, Nova Scotia

Halifax, Nova Scotia, Canada, B3H 2Y9

India

Lucknow, India, 226 014

Russian Federation

Moscow, Russian Federation, 125167

Moscow, Russian Federation, 129110

Slovakia

Kosice, Slovakia, 040 66

South Africa

Durban, South Africa, 4091

Spain

Valencia, Spain, 46009

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Chair: Clinical Trials; Hoffmann-La Roche

More Information

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02829775
• Other Study ID Numbers: NO17754; 2004-002093-30 ( EudraCT Number )
• First Posted: July 12, 2016
• Results First Posted: November 17, 2016
• Last Update Posted: January 9, 2017
• Last Verified: July 2016

Additional relevant MeSH terms:

Carcinoma; Leukemia; Melanoma; Leukemia, Myeloid; Carcinoma, Renal Cell; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Adenocarcinoma; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a; Antineoplastic Agents; Antiviral Agents