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Interferon Alpha-2b (Intron A) for Metastatic or Unresectable Clear Cell Renal Carcinoma

This study has been withdrawn prior to enrollment.
(Withdrawn in October 2006, no longer of interest)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00293527
First Posted: February 17, 2006
Last Update Posted: May 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas Olencki, Ohio State University Comprehensive Cancer Center
  Purpose
This study will determine the response rate of daily low dose interferon-alpha-2b in patients with metastatic or unresectable clear cell renal cell carcinoma.

Condition Intervention Phase
Renal Cancer Drug: Interferon Alpha-2b Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Dose Escalation Study of Continuous Daily Subcutaneous Administration of Interferon Alpha-2b in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Thomas Olencki, Ohio State University Comprehensive Cancer Center:

Enrollment: 0
Estimated Study Completion Date: November 2006
Detailed Description:

Rationale: Interferon has long been used as a therapy for renal cell carcinoma. However, optimal dosing schedules have not been identified and patients have been relegated to receiving the highest possible doses for prolonged periods of time. This high-dose approach often leads to serious adverse effects from toxicity that limits the usefulness and patient tolerance of this treatment. No formal study has determined the relationship if any between the maximal tolerated dose (MTD) and the biological effective dose of interferon alpha-2b. The current study seeks to fill that gap by gathering research information about different doses of interferon alpha-2b and correlating with measurements of JAK/STAT in the blood. Validation of correlative studies to determine optimum biologic dosing are needed so that therapy may be adjusted appropriately rather then the current approach of maximizing dose. In addition, a trial of low dose daily administered interferon-2b has not been carried out in the current era with refined histologic classification and modern CT imaging scanning. As this therapy potentially has wide applicability, definite response rates need to be documented.

Purpose: The purpose of this study is to assess the response rate of daily low dose interferon-2b in patients with metastatic or unresectable clear cell renal carcinoma. The duration of the response and overall survival will be determined in study participants. This study will also evaluate JAK/STAT, two types of kinases or enzymes involved in an intracellular signaling process associated with cancer growth, in peripheral blood mononuclear cells over the course of interferon alpha-2b dose escalation. Researchers will examine in a preliminary manner the correlation between clinical response, toxicity, and JAK/STAT signal transduction. Progression free survival and rate of stable disease will also be determined in a preliminary manner.

Treatment: Study participants will receive interferon alpha-2b. This drug will be self-administered daily through injections into the skin. The dose level of interferon alpha-2b will be increased each week into study treatments. For the first three weeks and approximately monthly thereafter, patients will have blood drawn three hours following interferon alpha-2b administration to measure JAK/STAT. Toxicity from study treatments will be closely monitored in patients during clinics visits. Supportive care therapies will be given throughout the study. Treatments will be discontinued due to disease growth or unacceptable side effects.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Metastatic or unresectable clear cell renal cell carcinoma
  • Measurable disease

Exclusion Criteria:

  • Prior interferon therapy
  • More than 3 prior therapy regimens
  Contacts and Locations
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): NCT00293527


Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Thomas Olencki Ohio State University
  More Information

Responsible Party: Thomas Olencki, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00293527     History of Changes
Other Study ID Numbers: OSU-05030
First Submitted: February 15, 2006
First Posted: February 17, 2006
Last Update Posted: May 23, 2013
Last Verified: May 2013

Keywords provided by Thomas Olencki, Ohio State University Comprehensive Cancer Center:
Metastatic

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Interferons
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs