Follicular Lymphoma Clinical Trial
Official title:
A Phase I Trial of Vaccination With Lethally Irradiated Lymphoma Cells Admixed With Granulocyte-Macrophage Colony Stimulating Factor Secreting K562 Cells for the Treatment of Previously Untreated or Relapses Follicular Lymphoma
Verified date | November 2023 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | October 2024 |
Est. primary completion date | July 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years and older |
Eligibility | 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 - 35 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 |
Country | Name | City | State |
---|---|---|---|
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the safety and toxicity of administering vaccine composed of lethally irradiated lymphoma cells admixed with GM-CSF secreting K562 cells in patients with follicular lymphoma. | 2 years | ||
Secondary | To describe the biologic activity of the study vaccine | 2 years | ||
Secondary | to determine tumor overall response rate as well as complete and partial response rates | 2 years | ||
Secondary | to determine progression free survival and overall survival. | 2 years |
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