Trial Information

Phase II Pilot Trial of Non-Myeloablative Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation Using Fludarabine, Low Dose TBI and Post-Transplant Cyclosporine and Mycophenolate Mofetil Followed by Donor Lymphocyte Infusion for Therapy of Advanced or Metastatic Human Papilloma Virus (HPV) - Associated Cervical Carcinoma Refractory to Standard Therapy

OBJECTIVES:

Primary

- Determine the partial or complete response in patients with recurrent metastatic or
locally advanced human papillomavirus (HPV)-associated cervical or vaginal carcinoma
treated with a nonmyeloablative regimen comprising fludarabine and low-dose total body
irradiation followed by allogeneic peripheral blood stem cell transplantation,
cyclosporine, mycophenolate mofetil, and donor lymphocyte infusion.

Secondary

- Determine the toxicity of this regimen in these patients.

- Determine whether this regimen induces engraftment and donor chimerism in these
patients.

- Determine the HPV-E6 and HPV-E7 specific T-cell responses in selected patients treated
with this regimen.

OUTLINE: This is a pilot study.

Patients receive conditioning therapy comprising fludarabine IV on days -4 to -2 and
low-dose total body irradiation on day 0. Filgrastim (G-CSF)-mobilized allogeneic peripheral
blood stem cells are infused on day 0.

Patients also receive oral cyclosporine twice daily on days -3 to 35 and then tapered until
day 56. Mycophenolate mofetil is administered orally twice daily on days 0-27.

Patients with disease progression and no graft-versus-host disease on day 56 receive
nonmobilized donor lymphocyte infusion (DLI) over 30 minutes on day 65. DLI may be repeated
every 65 days for up to 4 doses.

Patients are followed weekly for 3 months, monthly for 6 months, every 6 months for 2 years,
and then annually for 5 years.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.