Interferon Alfa and Interleukin-6 in Treating Patients With Recurrent Multiple Myeloma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00470093
First received: May 3, 2007
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-6 may stimulate the white blood cells to kill cancer cells. Giving interferon alfa together with interleukin-6 may kill more cancer cells.

PURPOSE: This clinical trial is studying the side effects and how well giving interferon alfa together with interleukin-6 works in treating patients with recurrent multiple myeloma.


Condition Intervention
Multiple Myeloma and Plasma Cell Neoplasm
Biological: recombinant interferon alfa
Biological: recombinant interleukin-6

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Pilot Study of Differentiation Therapy in Multiple Myeloma Using Interleukin-6 and Interferon-a

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
  • Optimal dose [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Impact of treatment on clonogenic growth of myeloma cells in serial in vitro assays [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: August 2007
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the response rate in patients with recurrent multiple myeloma treated with recombinant interferon alfa and recombinant interleukin-6.
  • Determine the safety and optimal dose of this regimen in these patients.
  • Determine the toxicity of this regimen in these patients.
  • Determine the impact of this regimen on clonogenic growth of myeloma cells in serial in vitro assays.

OUTLINE: This is a pilot study.

Patients receive recombinant interferon alfa subcutaneously (SC) once daily. Beginning 1 month later, patients also receive recombinant interleukin-6 SC once daily. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of recurrent multiple myeloma
  • Must have received ≥ 2 prior therapies

PATIENT CHARACTERISTICS:

  • Performance status 0-3

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470093

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Carol A. Huff, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00470093     History of Changes
Other Study ID Numbers: J0620 CDR0000543428, P30CA006973, P01CA015396, JHOC-J0620, JHOC-NA_00002178
Study First Received: May 3, 2007
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Interferon-alpha
Interferon Alfa-2a
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 10, 2014