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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

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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:
Information provided by (Responsible Party):
Hoffmann-La Roche

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

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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


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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02829775


Locations
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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
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Study Chair: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02829775    
Other Study ID Numbers: NO17754
2004-002093-30 ( EudraCT Number )
First Posted: July 12, 2016    Key Record Dates
Results First Posted: November 17, 2016
Last Update Posted: January 9, 2017
Last Verified: July 2016
Additional relevant MeSH terms:
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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