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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-02003 | Registry Identifier | NCI-CTRP | |
| LS1081 | Other Identifier | Mayo Clinic Cancer Center & SPORE | |
| 10-003023 | Other Identifier | Mayo Clinic IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVES: I. Evaluation of safety and tolerability as measured by the incidence of significant toxicity of an autologous DC vaccine injection into a cryoablated tumor site (Arm A). II. Evaluation of safety and tolerability as measured by the incidence of significant toxicity of an autologous mature DC vaccine + tumor lysate generated in vitro and delivered intradermally (ID) (Arm B). SECONDARY OBJECTIVES: I. For cryoablation candidates: To assess feasibility, overall response rate, clinical benefit rate, time to response, and duration of response (Arm A). II. For patients receiving ID vaccine without cryoablation: To assess feasibility, clinical response rate, time to response, and duration of response (Arm B). TERTIARY OBJECTIVES: I. For cryoablation candidates: To assess the change over time in non-cryoablated nodes selected as the index lesions (Arm A). II. For patients receiving ID vaccine without cryoablation: To assess the change over time in measurable nodes selected as the index lesions (Arm B). III. To monitor patients' immune response after vaccine therapy. IV. Assess the immune response to Prevnar in cancer patients. V. Assess the effect of DC vaccination on presence of myeloid suppressors. VI. Assess the effect of tumor antigen delivery methods (in vivo DC into cryoablated tumor vs. ID injection of in vitro generated DC + lysate) on T cell response. OUTLINE: Patients are assigned to 1 of 2 treatment arms. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year, and then every 6 months for up to 2.5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dendritic cell vaccine therapy | Biological | Given intratumorally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi Lin, M.D. | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| cryotherapy |
| Procedure |
Undergo cryoablation |
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| pneumococcal polyvalent vaccine | Biological | Given intramuscularly |
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| laboratory biomarker analysis | Other | Correlative studies |
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| immunoenzyme technique | Other | Correlative studies |
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| immunohistochemistry staining method | Other | Correlative studies |
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| autologous dendritic cell-tumor fusion vaccine | Biological | Given intradermally |
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| 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 |
| 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) |
| 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 |
| Correlation of immunologic markers with cancer and treatment-related outcomes (e.g., response, toxicities) | Up to 2.5 years |
| ID | Term |
|---|---|
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008228 | Lymphoma, Non-Hodgkin |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D022242 | Pneumococcal Vaccines |
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
| D007124 | Immunoenzyme Techniques |
| D007150 | Immunohistochemistry |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D007118 | Immunoassay |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| D015336 | Molecular Probe Techniques |
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
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