Peripheral Stem Cell Transplant, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer

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Brief Title

Peripheral Stem Cell Transplant, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer

Official Title

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

Brief Summary

      RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy
      before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells.
      It also stops the patient's immune system from rejecting the donor's stem cells. The donated
      stem cells may replace the patient's immune system and help destroy any remaining cancer
      cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor
      lymphocyte infusion) after the transplant may help increase this effect. Sometimes the
      transplanted cells from a donor can also make an immune response against the body's normal
      cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from

      PURPOSE: This phase II trial is studying how well donor peripheral stem cell transplant plus
      chemotherapy and total-body irradiation followed by donor white blood cell infusion work in
      treating patients with recurrent metastatic or locally advanced cancer of the cervix or
      vagina that is associated with human papillomavirus.

Detailed Description



        -  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.


        -  Determine the toxicity of this regimen in these patients.

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

        -  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.

Study Phase

Phase 2

Study Type


Primary Outcome

Partial or complete response

Secondary Outcome



Cervical Cancer


therapeutic allogeneic lymphocytes


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Start Date

November 1999

Completion Date

June 2005

Primary Completion Date

June 2005

Eligibility Criteria


          -  Histologically confirmed recurrent metastatic or locally advanced cervical or vaginal
             carcinoma that is not curable with surgery or radiotherapy

               -  Tumor is human papillomavirus positive by polymerase chain reaction

          -  Bidimensionally measurable disease by clinical examination or radiographic imaging

          -  Availability of an genotypically HLA-identical sibling donor (excluding identical

          -  No brain metastases



          -  Under 65

        Performance status:

          -  Karnofsky 80-100%

        Life expectancy:

          -  Not specified


          -  Not specified


          -  Bilirubin no greater than 2 times upper limit of normal (ULN)

          -  SGOT and SGPT no greater than 2 times ULN


          -  Creatinine clearance at least 40 mL/min


          -  Cardiac ejection fraction at least 40%

          -  No history of congestive heart failure

          -  No poorly controlled hypertension


          -  No severe defects in pulmonary function

          -  No supplementary continuous oxygen


          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception during and for 12 months after study

          -  HIV negative


        Biologic therapy:

          -  Concurrent growth factors for severe persistent or febrile neutropenia after
             transplantation allowed


          -  Not specified

        Endocrine therapy:

          -  Not specified


          -  See Disease Characteristics


          -  See Disease Characteristics




N/A - 64 Years

Accepts Healthy Volunteers



Richard Nash, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Study Sponsor

Fred Hutchinson Cancer Center


 National Cancer Institute (NCI)

Study Sponsor

Richard Nash, MD, Study Chair, Fred Hutchinson Cancer Center

Verification Date

March 2010