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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00005941 on ClinicalTrials.gov