Trial Information

A Phase II Trial Using a Universal GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) in the Formulation of Autologous Tumor Cell-Based Vaccines for Patients With Mantle Cell Lymphoma

OBJECTIVES:

Primary

- Determine the specific anti-tumor immune response in patients with relapsed or de novo
stage II, III, or IV mantle cell lymphoma treated with vaccine therapy comprising
autologous tumor cells and a sargramostim (GM-CSF)-producing and CD40L-expressing cell
line (GM.CD40L) combined with low-dose interleukin-2 after conventional chemotherapy.

- Determine the toxicity of this regimen in these patients.

Secondary

- Determine the tumor response rate, time to progression, disease-free survival, and
overall survival of patients treated with this regimen.

OUTLINE: Patients undergo surgical resection of a malignant lymph node to collect autologous
tumor cells for vaccine production. Vaccine is formulated by combining equal volumes of
irradiated autologous tumor cells and irradiated cells from a cell line that produces
sargramostim (GM-CSF) and expresses CD40L (GM.CD40L).

- Conventional chemotherapy: Patients receive conventional chemotherapy comprising 6
courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3
courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and
dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for
patients who have relapsed after CHOP. Patients who achieve a partial or complete
response after completion of chemotherapy proceed to vaccine therapy.

- Vaccine therapy: Patients receive vaccine comprising autologous tumor cells and
GM.CD40L intradermally on day 1 and low-dose interleukin-2 (IL-2) subcutaneously twice
daily on days 1-14. Treatment repeats every 28 days for 4 courses. Patients who have
stable or responding disease at 12 months receive 4 additional courses of booster
vaccine and low-dose IL-2 as above. Treatment continues in the absence of disease
progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then annually thereafter.

PROJECTED ACCRUAL: A total of 40-60 patients will be accrued for this study within 15
months.