Peripheral Stem Cell Transplant, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer
NCT00005941 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2010-04-02
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 happening.
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.
Conditions
- Cervical Cancer
- Vaginal Cancer
Interventions
- BIOLOGICAL
-
therapeutic allogeneic lymphocytes
- DRUG
-
cyclosporine
- DRUG
-
fludarabine phosphate
- DRUG
-
mycophenolate mofetil
- PROCEDURE
-
peripheral blood stem cell transplantation
- RADIATION
-
radiation therapy
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Fred Hutchinson Cancer Center
lead OTHER
Principal Investigators
-
Richard Nash, MD · Fred Hutchinson Cancer Center
Study Design
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Max Age
- 64 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1999-11-30
- Primary Completion
- 2005-06-30
- Completion
- 2005-06-30
Countries
- United States
Study Locations
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