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

This study is currently recruiting participants.
Verified March 2012 by Mayo Clinic

First Received on October 27, 2010.  
Last Updated on March 15, 2012  
History of Changes
This Clinical Trial Sponsored By: Mayo Clinic
Collaborator: National Cancer Institute (NCI)
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01239875
 

Purpose for Clinical Trial

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 residual, relapsed, or refractory B-cell Non-Hodgkin’s lymphoma.

Condition Study Intervention
Cutaneous B-cell Non-Hodgkin Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Intraocular Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Small Lymphocytic Lymphoma
Splenic Marginal Zone Lymphoma
Waldenstrom Macroglobulinemia
Biological: dendritic cell vaccine therapy
Procedure: cryotherapy
Biological: pneumococcal polyvalent vaccine
Other: laboratory biomarker analysis
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Biological: autologous dendritic cell-tumor fusion vaccine

Study Type: Study Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Study Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: LS1081, "A Pilot Study of Dendritic Cell Therapy Delivered Intratumorally After Cryoablation or Intradermally for Patients With Residual, Relapsed, or Refractory B-Cell Non-Hodgkin’s Lymphoma"

Resource links provided by NLM:

Genetics Home Reference related topics:
aceruloplasminemia
hemophilia
MedlinePlus related topics:
Cancer
Lymphoma
Drug Information available for:
Heptavalent pneumococcal conjugate vaccine
Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures For Clinical Trial:

  • Incidence of significant toxicity as assessed by the CTEP Active Version CTCAE [ Time Frame: At day 1 of each course beginning in week 2, every 3 months for 1 year, and during documented progressive disease ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures For Clinical Trial:

  • Overall response rate [ Time Frame: At week 4 (arm A) or 2 (arm B) and then every 3 months for 1 year starting at week 10 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Up to 2.5 years ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: For at least 12 months ] [ Designated as safety issue: No ]
  • Time to response [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Percent change from baseline in index lesion measurements as a marker of distant immune and treatment response [ Time Frame: At day 1 of courses 1-4 (arm A) and 1-6 (arm B) ] [ Designated as safety issue: No ]
  • Change in immunologic correlates before and after vaccination treatment [ Time Frame: At day 1 of each course beginning in week 2, every 3 months for 1 year, and during documented progressive disease ] [ Designated as safety issue: No ]
  • Correlation of immunologic markers with cancer and treatment-related outcomes (e.g., response, toxicities) [ Time Frame: Up to 2.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: November 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Experimental: Arm A

Patients receive pneumococcal polyvalent vaccine intramuscularly in weeks -4 and 2. Patients undergo cryoablation followed by dendritic cell vaccine (CA-DC) intratumorally in weeks 0 and 2.
Biological: dendritic cell vaccine therapy

Given intratumorally

Procedure: cryotherapy

Undergo cryoablation

Biological: pneumococcal polyvalent vaccine

Given intramuscularly
Other Names:
  • Pneumovax 23
  • Pnu-Imune 23

Other: laboratory biomarker analysis

Correlative studies

Other: immunoenzyme technique

Correlative studies
Other Name: immunoenzyme techniques

Other: immunohistochemistry staining method

Correlative studies
Other Name: immunohistochemistry
Experimental: Arm B

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, and 6.
Biological: pneumococcal polyvalent vaccine

Given intramuscularly
Other Names:
  • Pneumovax 23
  • Pnu-Imune 23

Other: laboratory biomarker analysis

Correlative studies

Other: immunoenzyme technique

Correlative studies
Other Name: immunoenzyme techniques

Other: immunohistochemistry staining method

Correlative studies
Other Name: immunohistochemistry

B

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