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

Sponsor:	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	Biological: aldesleukin Biological: idiotype-pulsed autologous dendritic cell vaccine APC8020 Biological: recombinant interferon gamma Genetic: polymerase chain reaction Genetic: reverse transcriptase-polymerase chain reaction Other: flow cytometry Other: laboratory biomarker analysis	Phase II

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

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Interferon gamma-1b Aldesleukin Interferons

U.S. FDA Resources

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
Estimated Primary Completion Date:	October 2008 (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

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000582566, MAYO-998003
Study First Received:	February 14, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00616720 History of Changes
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 multiple myeloma

Additional relevant MeSH terms:

Anti-Infective Agents
Interferon Type II
Blood Protein Disorders
Antineoplastic Agents
Paraproteinemias
Hemostatic Disorders
Hemorrhagic Disorders
Anti-Retroviral Agents
Therapeutic Uses
Cardiovascular Diseases
Immunoproliferative Disorders
Neoplasms by Histologic Type
Anti-HIV Agents

Immune System Diseases
Hematologic Diseases
Interferons
Vascular Diseases
Antiviral Agents
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Aldesleukin
Lymphoproliferative Disorders
Neoplasms, Plasma Cell
Interferon-gamma, Recombinant

ClinicalTrials.gov processed this record on February 08, 2010