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

Lymphoma, Non-Hodgkin Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006434
• Other study ID #: NCRR-M01RR00042-1694
• Secondary ID: M01RR000042
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2000
• Last updated: June 23, 2005

Study information

• Verified date: December 2003
• Source: National Center for Research Resources (NCRR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 70 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin

Intervention

Biological:
• tumor-pulsed dendritic cells

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States,