Vaccine Therapy With or Without Cryosurgery in Treating Patients With Residual, Relapsed, or Refractory B-Cell Non-Hodgkin Lymphoma

NCT01239875 | Completed Early Phase 1 DMC

• 3 other identifiers: LS1081NCI-2010-0200310-003023
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines, such as dendritic cell therapy (DC) made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Cryosurgery kills cancer cells by freezing them. Giving vaccine therapy together with cryosurgery may kill more tumor cells. PURPOSE: This clinical trial studies giving vaccine therapy together with or without cryosurgery in treating patients with B-cell Non-Hodgkin's lymphoma.

Conditions

Cutaneous B-cell Non-Hodgkin Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Nodal Marginal Zone B-cell Lymphoma; Adult Diffuse Mixed Cell Lymphoma; Adult Diffuse Small Cleaved Cell Lymphoma; Adult Grade III Lymphomatoid Granulomatosis; Adult Immunoblastic Large Cell Lymphoma; Adult Lymphoblastic Lymphoma; Grade 1 Follicular Lymphoma; Grade 2 Follicular Lymphoma; Grade 3 Follicular Lymphoma; Mantle Cell Lymphoma; Marginal Zone Lymphoma; Small Lymphocytic Lymphoma; Splenic Marginal Zone Lymphoma; Waldenstrom Macroglobulinemia With Nodal Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of significant toxicity as assessed by the CTEP Active Version CTCAE

  At day 1 of each course beginning in week 2, every 3 months for 1 year, and during documented progressive disease

Secondary Outcomes (8)

• Overall response rate

  At week 4 (arm A) or 2 (arm B) and then every 3 months for 1 year starting at week 10

• Feasibility as estimated by the number of patients receiving at least one dose of tumor antigen loading and vaccine delivery divided by the number receiving leukapheresis

  Up to 2.5 years

• Clinical benefit rate as estimated by the number of patients with an objective status of stable disease (SD) or an objective status of CR or PR

  For at least 12 months

• Time to response

  From the date of initiation of vaccination treatment to the date at which the patient's objective status is first noted to be either a CR or PR

• Duration of response

  From the date at which the patient's objective status is first noted to be either a CR or PR to the earliest date progression is documented

Study Arms (2)

Arm A

EXPERIMENTAL

Patients receive pneumococcal polyvalent vaccine intramuscularly in weeks -4, 2, and 10. Patients undergo cryoablation followed by dendritic cell vaccine (CA-DC) intratumorally in weeks 0, 2, 4, 6, 10, 14, 18, and 22.

Biological: dendritic cell vaccine therapy; Procedure: cryotherapy; Biological: pneumococcal polyvalent vaccine; Other: laboratory biomarker analysis; Other: immunoenzyme technique; Other: immunohistochemistry staining method

Arm B

EXPERIMENTAL

Patients receive pneumococcal polyvalent vaccine as in arm A. Patients also receive autologous dendritic cell-tumor fusion vaccine (TL-DC) intradermally in weeks 0, 2, 4, 6, 10, 14, 18, and 22.

Biological: dendritic cell vaccine therapy; Biological: pneumococcal polyvalent vaccine; Other: laboratory biomarker analysis; Other: immunoenzyme technique; Other: immunohistochemistry staining method; Biological: autologous dendritic cell-tumor fusion vaccine

Interventions

dendritic cell vaccine therapy BIOLOGICAL

Given intratumorally

Arm A; Arm B

cryotherapy PROCEDURE

Undergo cryoablation

Arm A

pneumococcal polyvalent vaccine BIOLOGICAL

Given intramuscularly

Also known as: Pneumovax 23, Pnu-Imune 23

Arm A; Arm B

laboratory biomarker analysis OTHER

Correlative studies

Arm A; Arm B

immunoenzyme technique OTHER

Correlative studies

Also known as: immunoenzyme techniques

Arm A; Arm B

immunohistochemistry staining method OTHER

Correlative studies

Also known as: immunohistochemistry

Arm A; Arm B

autologous dendritic cell-tumor fusion vaccine BIOLOGICAL

Given intradermally

Arm B

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological confirmation of biopsy-proven B-cell non-Hodgkin's lymphoma, excluding chronic lymphocytic leukemia, primary CNS lymphoma and Burkitt's lymphoma.
• Patient must have at least 2 measurable lesions that are \>= 1.5cm in one dimension. One of the lesions, must meet additional criteria a or b depending on the treatment arm. a) For Arm A, patient must have at least one lesion that is \>= 2.0cm and is amenable to image-guided cryoablation and multiple vaccine injections as determined by Interventional Radiology (including tumors that can be safely accessed using imaging guidance and treated with minimal risk to adjacent structures). b) For Arm B, patient must have one lesion that can be excised for in vitro vaccine preparation.
• ECOG Performance Status (PS) 0, 1, 2
• Absolute neutrophil count \> 1000/uL
• Absolute lymphocyte count \> 500/uL
• PLT \>= 100,000/uL
• HgB \>= 8.0 g/dL
• Total bilirubin =\< 1.5 x upper limit of normal (ULN) or if total bilirubin is \> 1.5 x ULN, the direct bilirubin must be normal
• Negative serum pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
• Provide informed written consent
• Willingness to return to a Lymphoma SPORE enrolling institution for follow-up
• Patient willing to provide tissue and blood samples for research purposes

You may not qualify if:

• Pregnant women
• Nursing women
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Patients known to be HIV positive
• Serious non-malignant disease such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations or other conditions which in the opinion of the investigator would compromise protocol objectives
• Receiving any other investigational agent considered as a treatment for the primary neoplasm
• History of other primary malignancy requiring systemic treatment within 6 months of protocol enrollment
• Patients must not have another active malignancy requiring treatment
• Patients must not be receiving chemotherapy or immunotherapy for another cancer
• Prior allogeneic bone marrow or peripheral blood stem cell transplantation
• Prior autologous bone marrow or peripheral blood stem cell support within 1 year
• Major surgery other than diagnostic surgery =\< 4 weeks
• History of hypersensitivity and anaphylactoid reactions to pneumococcal vaccine or any component of the formulation, including diphtheria toxoid
• Active autoimmune disease such as Crohn's disease, rheumatoid arthritis, Sjogrens' disease, systemic lupus erythematosis, or similar conditions
• Coagulopathy, including the use of Coumadin or heparin anticoagulants that cannot be discontinued for the cryoablation procedure (NOTE: Heparin for line patency without detectable lab abnormalities for coagulation will be allowed)

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone; Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell, Immunoblastic; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Cryotherapy; Pneumococcal Vaccines; 23-valent pneumococcal capsular polysaccharide vaccine; Immunoenzyme Techniques; Immunohistochemistry

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Immunoassay; Immunologic Techniques; Investigative Techniques; Molecular Probe Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques

Study Officials

• Yi Lin, M.D.

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: November 11, 2010
• Study Start: November 1, 2010
• Primary Completion: November 24, 2015
• Study Completion: July 17, 2019
• Last Updated: January 14, 2020

Record last verified: 2019-01

Locations

US (1)