Clinical trial NCT00569309: Immune Reconstitution After Autologous Hematopoietic Stem Cell Transpl for High-Risk Lymphoma
Official title: Immune Reconstitution After Autologous Hematopoietic Stem Cell Transplantation for High-Risk Lymphoma and Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Small Intestine Cancer
Keywords: contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
recurrent mantle cell lymphoma
stage I mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
recurrent adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage I grade 3 follicular lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
recurrent adult Hodgkin lymphoma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
stage I adult diffuse large cell lymphoma
adult nasal type extranodal NK/T-cell lymphoma
angioimmunoblastic T-cell lymphoma
anaplastic large cell lymphoma
small intestine lymphoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2007-12-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Experiencing Immune Reconstitution
timeFrame: Up to 2 years
Secondary outcomes:
measure: 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)
timeFrame: Up to 3 years
measure: Correlation of Quality of Life With Inflammatory Cytokine Production of Peripheral Blood Monocytes
timeFrame: Up to 3 years
measure: Quality of Life, Including Brief Pain Inventory
timeFrame: Up to 3 years
measure: Quality of Life, Including Fatigue
timeFrame: Up to 3 years
measure: Collection of Baseline Immune Reconstitution and Quality of Life Pilot Data for Comparison in Future Post-transplant Immunotherapy Trials
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Craig C. Hofmeister, MD
role: PRINCIPAL_INVESTIGATOR
References: