Immune Reconstitution After Autologous Hematopoietic Stem Cell Transpl for High-Risk Lymphoma

NCT ID: NCT00569309

Last Updated: 2018-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-12
• Study Completion Date: 2011-07-29

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).

Conditions

Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Small Intestine Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prevnar

The conjugate vaccine for Streptococcus pneumoniae will be administered during weeks 9, 17, and 25 after autologous HSCT - the study nurse will arrange for the vaccine to be administered at the specified time and the patient will be instructed to notify an investigator or study nurse of any side effects of vaccine administration. At the specified times, patients will fill out the quality-of-life assessment. All patients enrolled on this trial will have samples procured for all proposed laboratory correlative studies.

Group Type: EXPERIMENTAL

Streptococcus pneumoniae

Intervention Type: BIOLOGICAL

Patients will receive 0.5 mL Prevnar in the deltoid muscle during weeks 9, 17, and 25 after autologous hematopoietic stem cell transplantation (HSCT)

laboratory correlative studies

Intervention Type: OTHER

Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.

quality-of-life assessment

Intervention Type: OTHER

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.

Interventions

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)

Intervention Type: BIOLOGICAL

laboratory correlative studies

Approximately 30-mL of blood will be collected and sent to the appropriate research lab(s) for processing.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Prevnar; PCV7; laboratory biomarker analysis; blood samples; QOL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig C. Hofmeister, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Countries

United States

Related Links

http://cancer.osu.edu

Jamesline

Other Identifiers

OSU-07044

Identifier Type: -

Identifier Source: org_study_id