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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphoma, Non-Hodgkin

Keywords

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Dendritic cells

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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tumor-pulsed dendritic cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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University of Michigan Medical Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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M01RR000042

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCRR-M01RR00042-1694

Identifier Type: -

Identifier Source: org_study_id