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

Completed · Early Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID: NCT01239875
Run by: Mayo Clinic
People needed: 16
Starts: 2010-11-01
Expected to finish: 2019-07-17
Last updated by the study team: 2020-01-14

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

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)
Patients must be off corticosteroids for at least 2 weeks prior to registration (this includes oral, IV, subcutaneous, or inhaled route of administration); patients on chronic corticosteroid for adrenal insufficiency or other reasons may enroll if they receive less than 10 mg/day of prednisone (or equivalent)
Patients with active CNS malignancy are not eligible for this trial

Where it is running

Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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