Vaccine Therapy in Treating Patients Who Have Undergone Autologous Stem Cell Transplant for High-Risk Lymphoma or Multiple Myeloma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Ohio State University Comprehensive Cancer Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Craig Hofmeister, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00569309
First received: December 6, 2007
Last updated: June 10, 2012
Last verified: June 2012

December 6, 2007
June 10, 2012
December 2007
November 2012   (final data collection date for primary outcome measure)
Immune reconstitution [ Time Frame: 2007-present ] [ Designated as safety issue: No ]
Immune reconstitution
Complete list of historical versions of study NCT00569309 on ClinicalTrials.gov Archive Site
  • Serial assessment of the absolute number of circulating regulatory T-cells and the function of these cells as measured by their expression of TGFβ and interleukin-10 (IL-10) [ Time Frame: 2007-present ] [ Designated as safety issue: No ]
  • Quality of life, including functional status, fatigue, and depression [ Time Frame: 2007-present ] [ Designated as safety issue: No ]
  • Correlation of quality of life with inflammatory cytokine production of peripheral blood monocytes [ Time Frame: 2007-present ] [ Designated as safety issue: No ]
  • Collection of baseline immune reconstitution and quality of life pilot data for comparison in future post-transplant immunotherapy trials [ Time Frame: 2007-present ] [ Designated as safety issue: No ]
  • Serial assessment of the absolute number of circulating regulatory T-cells and the function of these cells as measured by their expression of TGFβ and interleukin-10 (IL-10)
  • Quality of life, including functional status, fatigue, and depression
  • Correlation of quality of life with inflammatory cytokine production of peripheral blood monocytes
  • Collection of baseline immune reconstitution and quality of life pilot data for comparison in future post-transplant immunotherapy trials
Not Provided
Not Provided
 
Vaccine Therapy in Treating Patients Who Have Undergone Autologous Stem Cell Transplant for High-Risk Lymphoma or Multiple Myeloma
Immune Reconstitution After Autologous Hematopoietic Stem Cell Transplantation for High-Risk Lymphoma and Myeloma

RATIONALE: Vaccines may help the body build an effective immune response to kill cancer cells. Giving vaccine therapy after an autologous stem cell transplant may kill any cancer cells that remain after transplant.

PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients who have undergone autologous stem cell transplant for high-risk lymphoma or multiple myeloma.

OBJECTIVES:

Primary

  • Assess immune reconstitution as measured by response to pneumococcal polyvalent vaccine, NK-cell activity against autologous lymphoblastoid cell lines, and cytomegalovirus and Epstein-Barr virus tetramer responses in patients who have undergone autologous hematopoietic stem cell transplantation for high-risk lymphoma or multiple myeloma.

Secondary

  • Assess the absolute number of circulating regulatory T-cells and the function of these cells as measured by their expression of TGFβ and interleukin-10 (IL-10).
  • Evaluate the effect of conditioning therapy on quality of life, including functional status, fatigue, and depression, in these patients.
  • Correlate quality of life with inflammatory cytokine production of peripheral blood monocytes at specified time points.
  • Provide baseline immune reconstitution and quality of life pilot data for comparison in future post-transplant immunotherapy trials.

OUTLINE: Patients receive pneumococcal polyvalent vaccine intramuscularly once in weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation.

Blood samples are collected periodically for correlative and immunological studies.

Quality of life (QOL) is assessed periodically using the QOL short form (SF-36, 4-week version), the Center for Epidemiologic Studies Depression scale (CES-D), and the Multidimensional Fatigue Symptom Inventory (MFSI-30).

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Small Intestine Cancer
  • Biological: Streptococcus pneumoniae
    Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)
    Other Names:
    • Prevnar
    • PCV7
  • Other: laboratory biomarker analysis
    Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.
  • Other: quality-of-life assessment
    Responses to Hospital Anxiety and Depression Scale, 9-item brief fatigue inventory 57, brief pain inventory, and the FACT-G. This should take each patient approximately 10-15 minutes to fill out all these surveys per instance.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
31
Not Provided
November 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma OR any of the following high-risk lymphomas:

    • Diffuse large B-cell lymphoma meeting any of the following criteria:

      • Failed induction therapy but responded to salvage therapy
      • Relapsed < 1 year after completion of induction therapy
      • Elevated lactic dehydrogenase (LDH) at relapse
      • Stage III or IV disease at relapse
      • Positive PET scan after induction or salvage therapy
      • Age 60 to 75 years
    • Follicular lymphoma meeting any of the following criteria:

      • Progressive disease after two or more prior regimens
      • Transformed to aggressive diffuse large B-cell lymphoma but is still chemotherapy sensitive
      • Not considered to be a good candidate for allogeneic stem cell transplantation
    • Hodgkin lymphoma meeting any of the following criteria:

      • Primary refractory disease
      • Relapsed < 1 year after completion of induction therapy
      • Relapsed with PET positive disease after salvage therapy
      • Relapsed refractory disease and is not considered to be a good candidate for allogeneic stem cell transplantation
    • Mantle cell lymphoma meeting any of the following criteria:

      • Chemotherapy sensitive disease after induction therapy
      • Chemotherapy sensitive relapsed disease and is not considered to be a good candidate for allogeneic stem cell transplantation
    • T-cell non-Hodgkin lymphoma (NHL) meeting any of the following criteria:

      • Peripheral T-cell lymphoma, not otherwise specified meeting at least one of the following criteria:

        • High LDH at diagnosis
        • Marrow involvement at diagnosis
        • Age > 60 years at diagnosis
        • Low platelet count at diagnosis
        • Chemotherapy sensitive relapsed disease
      • Angioimmunoblastic lymphadenopathy with dysproteinemia
      • ALK-negative anaplastic NHL
      • Enteropathy-associated T-cell NHL
      • Stage III or IV NK-/T-cell NHL at diagnosis
      • NK-blastic NHL
  • Has undergone autologous hematopoietic stem cell transplantation and received 200 mg/m² of melphalan (for multiple myeloma) OR BEAM chemotherapy comprising carmustine, etoposide, cytarabine, and methotrexate (for high-risk lymphoma) as conditioning therapy

PATIENT CHARACTERISTICS:

  • ECOG or WHO performance status 0-2
  • ANC ≥ 1,000/μL
  • Platelet count ≥ 75,000/μL
  • Total bilirubin ≤ 1.5 mg/dL
  • Alkaline phosphatase ≤ 2 times upper limit of normal (ULN)
  • AST and ALT ≤ 2 times the ULN
  • Not pregnant or nursing
  • No severe or uncontrolled systemic illness
  • No "currently active" second malignancy, other than nonmelanoma skin cancer or carcinoma in situ of the cervix

    • Patients are not considered to have a "currently active" malignancy if they completed therapy for the malignancy, are disease free from the malignancy for > 5 years, and are considered by their physician to be at < 30% risk of relapse
  • No significant history of uncontrolled cardiac disease including, but not limited to, any of the following:

    • Uncontrolled hypertension
    • Unstable angina
    • Recent myocardial infarction (within the past 6 months)
    • Uncontrolled congestive heart failure
  • No active bacterial, fungal, or viral infection
  • No known HIV infection or active hepatitis B and/or hepatitis C infection
  • No other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with the patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the study results

PRIOR CONCURRENT THERAPY:

  • No concurrent biologic therapy, chemotherapy, or other antineoplastic therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00569309
OSU-07044
Yes
Craig Hofmeister, Ohio State University Comprehensive Cancer Center
Craig Hofmeister
Not Provided
Principal Investigator: Craig C. Hofmeister, MD Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP