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Tumor Lysate Pulsed-Dendritic Cell Vaccines After High-Dose Chemotherapy for Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma, Non-Hodgkin

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
tumor-pulsed dendritic cells
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Dendritic cells

Eligibility Criteria

10 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically documented, aggressive and/or intermediate grade NHL, B-cell and T-cell. In relapse after first-line conventional chemotherapy. Primary therapy should include a doxorubicin-based regimen. Patients must have disease sensitive to induction chemotherapy, radiation therapy, and/or radioimmunotherapy. Successful treatment of CNS or meningeal disease is allowed. Patients must have accessible tumor for biopsy or excision. Cumulative total doxorubicin: <500 mg/m2 Performance score 0-2 No prior pelvic RT Patients with a prior malignancy are eligible if they were treated for cure and have no evidence of active disease. Patients may not be taking immunosuppressive agents. Informed Consent; IRB approval

Sites / Locations

  • University of Michigan Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT00006434
Brief Title
Tumor Lysate Pulsed-Dendritic Cell Vaccines After High-Dose Chemotherapy for Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Research Resources (NCRR)

4. Oversight

5. Study Description

Brief Summary
When patients relapse after primary chemotherapy for Non-Hodgkin's lymphoma, they may be eligible to receive high-dose chemotherapy with autologous stem cell support. Unfortunately high-dose chemotherapy is curative in less than half the patients who receive it. This study is being conducted to determine the safety, side effects, and the ability to respond to an investigational vaccine that consists of tumor-pulsed dendritic cells given with an immune stimulating drug called interleukin-2. The patient must have a lymphomatous node accessible for excision to prepare the vaccine. Dendritic cells are immune cells that are obtained from the blood, and are important in the body's immune response to foreign substances. This study will examine the response of the immune system after three vaccinations (composed of dendritic cells, which have been exposed to dead fragments of lymphoma cells) given beginning three months after transplant. Vaccination may result in sensitizing the patient's dendritic cells to his lymphoma cells, potentially resulting in an immune response against the lymphoma. Twelve patients will be treated on study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin
Keywords
Dendritic cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
tumor-pulsed dendritic cells

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically documented, aggressive and/or intermediate grade NHL, B-cell and T-cell. In relapse after first-line conventional chemotherapy. Primary therapy should include a doxorubicin-based regimen. Patients must have disease sensitive to induction chemotherapy, radiation therapy, and/or radioimmunotherapy. Successful treatment of CNS or meningeal disease is allowed. Patients must have accessible tumor for biopsy or excision. Cumulative total doxorubicin: <500 mg/m2 Performance score 0-2 No prior pelvic RT Patients with a prior malignancy are eligible if they were treated for cure and have no evidence of active disease. Patients may not be taking immunosuppressive agents. Informed Consent; IRB approval
Facility Information:
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104-0914
Country
United States

12. IPD Sharing Statement

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Tumor Lysate Pulsed-Dendritic Cell Vaccines After High-Dose Chemotherapy for Non-Hodgkin's Lymphoma

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