Vaccination for the Treatment of Previously Untreated or Relapsed Follicular Lymphoma

Status: Recruiting
Phase: Phase 1
Diagnosis: Non-Hodgkin's Lymphoma
NCT ID: NCT00487305 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 06-275

 

The purpose of this study is to compare the safety and immune activity of three doses of tumor vaccine. In recent years, researchers at the Dana-Farber Cancer Institute have discovered that vaccines made from patient's own cancer cell, that have been engineered in the laboratory to produce a protein called GM-CSF, can be effective in stimulating a powerful immune response specific to that cancer. GM-CSF is a naturally occuring hormone in the body that helps our immune system fight infections and diseases. One of the goals of this study is to determine whether these vaccinations will improve the immune system's ability to recognize and destroy the participant's lymphoma cells.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Eric Jacobsen, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Nicole Gallo, 617-582-7970, nicole_gallo@dfci.harvard.edu

Eligibility Criteria

Inclusion Criteria: - Histologically confirmed follicular lymphoma - Patients with relapsed follicular lymphoma achieving at least a PR following their most recent systemic chemotherapy and/or immunotherapy regimen. - Lymphoma accessible for sampling or existing cryopreserved lymphoma tumor judged suitable for vaccine preparation. - 4 weeks must have elapsed between the completion of the the last chemotherapy, immunotherapy, glucocorticoid therapy, radiotherapy, or experimental therapy. - ECOG Performance Status 0 or 1 - Estimated life expectancy of > 6 months - 40 years of age or older - Adequate recovery of drug related toxicities, surgery or radiation therapy - Greater than 6 months since autologous stem cell transplantation - Laboratory parameters as outlined in the protocol Exclusion Criteria: - Uncontrolled active infection or illness - Psychiatric illness/social situation that would limit study compliance - Pregnancy or nursing mothers - Evidence of infection with HIV or viral hepatitis - Other invasive malignancy - Existing autoimmune cytopenia - Previous allogeneic stem cell transplant - Pre-existing autoimmune disease requiring anti-inflammatory therapy - Participation in previous vaccine trial - Any component of grade 3 follicular lymphoma or transformed follicular lymphoma
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