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Interferon-Gamma or Aldesleukin and Vaccine Therapy in Treating Patients With Multiple Myeloma

This study is ongoing, but not recruiting participants.

Sponsored by: Mayo Clinic
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00616720
  Purpose

RATIONALE: Biological therapies, such as interferon-gamma and aldesleukin, may stimulate the immune system in different ways and stop cancer cells from growing. Vaccines made from a person's white blood cells may help the body build an effective immune response to kill cancer cells. Giving biological therapy together with vaccine therapy may kill more cancer cells.

PURPOSE: This randomized phase II trial is studying how well giving aldesleukin or interferon gamma together with vaccine therapy works in treating patients with multiple myeloma.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: aldesleukin
Drug: idiotype-pulsed autologous dendritic cell vaccine APC8020
Drug: recombinant interferon gamma
Procedure: flow cytometry
Procedure: laboratory biomarker analysis
Procedure: polymerase chain reaction
Procedure: reverse transcriptase-polymerase chain reaction
Phase II

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Cancer    Multiple Myeloma   

ChemIDplus related topics:   Aldesleukin    Interferon alfa-2b    Interferons    Interferon gamma-1b   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
Official Title:   Randomized Phase II Trial of Dendritic Cell-Based Idiotype Vaccination With Adjuvant Cytokines for Plateau Phase and Post-Transplant Multiple Myeloma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Confirmed response (i.e., clinical or immunological) [ Designated as safety issue: No ]

Estimated Enrollment:   15
Study Start Date:   August 2001
Primary Completion Date:   April 2003 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

  • To assess the clinical benefit in patients with plateau phase multiple myeloma treated with interferon-gamma vs aldesleukin in combination with idiotype-pulsed autologous dendritic cell vaccine APC8020.
  • To describe response rates in patients who are in plateau phase status post-chemotherapy or status post-peripheral blood cell transplantation treated with this regimen.

Secondary

  • To obtain data regarding the ability of this approach to produce an anti-idiotypic immunologic response.
  • To obtain information about the effects of interferon-gamma and aldesleukin on the number, function, and activation state of immune effector-cells including T-cells and B-cells.
  • To perform detailed analyses of lymphocyte phenotypes and T-cell repertoires before and after idiotype-pulsed autologous dendritic cell vaccine APC8020.

OUTLINE: Patients are stratified according to gender (male vs female) and prior treatment (post-chemotherapy vs post-peripheral blood stem cell transplantation). Patients are randomized to 1 of 2 arms.

In both arms, patients undergo apheresis for collection of peripheral blood mononuclear cells for generation of dendritic cells (DC) on days 0, 14, and 28. APC8020 is generated by loading DC with immunoglobulin idiotype prepared from the patient's serum.

  • Arm I: Patients receive interferon-gamma subcutaneously (SC) once daily on days 1-5, 15-20, and 29-34 and idiotype-pulsed autologous dendritic cell vaccine APC8020 IV over 30-minutes on days 2, 16, and 30.
  • Arm II: Patients receive aldesleukin SC once daily days 1-5, 15-20, and 29-34 and idiotype-pulsed autologous dendritic cell vaccine APC8020 as in arm I.

In both arms, treatment continues in the absence of disease progression.

Peripheral blood samples are collected at baseline and on day 5 of courses 1 and 4 for cytokine immunomodulatory studies, including immunophenotyping for lymphocyte phenotypic markers (CD69, CD40L, CD25, CD30, CD71, CDW137, CD134, and HLADR) by flow cytometry and immunofluorescence; T-cell spectratyping by PCR and RT-PCR; T-cell proliferation to idiotype protein; and CTL and T-helper response by flow cytometry.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months thereafter.

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

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma
  • Plateau phase multiple myeloma (status post chemotherapy or status post-peripheral blood cell transplantation), meeting the following criteria:

    • Serum and urine monoclonal (M) protein values must be stable (< 20% variation) or must have disappeared
    • Serum M protein < 1 g/dL, and 1 of the following:

      • Quantifiable serum M protein
      • Adequate serum sample stored in Transfusion Medicine under IRB protocol #698-98
    • Urine M protein < 200 mg/24 hours by electrophoresis on 2 separate occasions for a period of ≥ 4 weeks
  • Serum M protein spike ≤ 2.0 g/dL
  • No progressive disease after prior autologous stem cell transplantation or chemotherapy
  • No non-secretory or light chain myeloma

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 6 months
  • WBC ≥ 1,500/μL
  • Platelet count ≥ 50,000/μL
  • Total bilirubin ≤ 5 times upper limit of normal
  • Creatinine ≤ 5.0 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must have adequate venous access for apheresis
  • No uncontrolled cardiac disease
  • No uncontrolled infection
  • No illness or condition which, in the opinion of the investigator, may affect safety of treatment or evaluation of any of the study's endpoints

PRIOR CONCURRENT THERAPY:

  • Recovered from all prior therapy
  • More than 4 weeks since prior standard-dose chemotherapy, radiotherapy, or immunotherapy
  • More than 3 months since prior high-dose chemotherapy with stem cell transplantation
  • No concurrent corticosteroids
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616720

Sponsors and Collaborators
Mayo Clinic

Investigators
Study Chair:     Martha Q. Lacy, MD     Mayo Clinic    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000582566, MAYO-998003
First Received:   February 14, 2008
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00616720
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I multiple myeloma  
stage II multiple myeloma  
stage III multiple myeloma  
refractory plasma cell neoplasm  

Study placed in the following topic categories:
Interferon-alpha
Immunoproliferative Disorders
Immunoglobulin Idiotypes
Interferon Type II
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Interferons
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Aldesleukin
Multiple myeloma
Interferon Alfa-2a
Lymphoproliferative Disorders
Interferon Alfa-2b
Interferon-gamma, Recombinant
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Anti-Retroviral Agents
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on October 10, 2008




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