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
- The dose of vaccine will depend upon how many of the participant's own tumor cells are
available and at which point they join study. This Phase I trial is a "dose
escalation" study. This means that participants will be enrolled in groups. Group 2
will receive a larger dose than Group 1. Group 3 will receive a larger dose than Group
- The vaccine is administered in injections under and into the skin six times.
Participants will receive vaccination shots once weekly for 3 vaccines, then every
other week for 3 vaccines.
- After the first and fifth vaccinations, a small amount of the participants own lymphoma
cells (killed) will be injected under the skin to see if their immune system will react
against it and cause redness and swelling. A punch skin biopsy will also be performed
at these injection locations.
- During the course of the study, we will also be drawing blood to evaluate immune cells
and the effect that the vaccinations have on the participants immune system. During
all treatment cycles a physical exam and questions about the participants general
health will be performed.
- After the final treatment (approximately week 10) the participant will undergo
"re-staging" to assess the status of their disease. If after completion of six
vaccines, evaluation of the participant's disease reveals that it is stable or
responding to the vaccine, and there is still vaccine available, they may be eligible
to continue to receive the vaccines every two weeks until their supply runs out.
- After completion of the vaccinations, participants will come back for physical exams
and blood tests every 3 months for 1 year and then once a year for fifteen years to
monitor the effects of the vaccine.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Eric Jacobsen, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|