Mantle Cell Lymphoma Clinical Trial
Official title:
LS1081, "A Pilot Study of Dendritic Cell Therapy Delivered Intratumorally After Cryoablation or Intradermally for Patients With B-Cell Non-Hodgkin's Lymphoma"
Verified date | January 2019 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | July 17, 2019 |
Est. primary completion date | November 24, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Overall response rate | At week 4 (arm A) or 2 (arm B) and then every 3 months for 1 year starting at week 10 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | Percent change from baseline in index lesion measurements as a marker of distant immune and treatment response | At day 1 of courses 1-4 (arm A) and 1-6 (arm B) | ||
Secondary | Change in immunologic correlates before and after vaccination treatment | At day 1 of each course beginning in week 2, every 3 months for 1 year, and during documented progressive disease | ||
Secondary | Correlation of immunologic markers with cancer and treatment-related outcomes (e.g., response, toxicities) | Up to 2.5 years |
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