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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


Phase 2
N/A
64 Years
Not Enrolling
Female
Cervical Cancer, Vaginal Cancer

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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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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
twins)

- No brain metastases

PATIENT CHARACTERISTICS:

Age:

- Under 65

Performance status:

- Karnofsky 80-100%

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

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

- SGOT and SGPT no greater than 2 times ULN

Renal:

- Creatinine clearance at least 40 mL/min

Cardiovascular:

- Cardiac ejection fraction at least 40%

- No history of congestive heart failure

- No poorly controlled hypertension

Pulmonary:

- No severe defects in pulmonary function

- No supplementary continuous oxygen

Other:

- Not pregnant or nursing

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

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Partial or complete response

Safety Issue:

No

Principal Investigator

Richard Nash, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1477.00

NCT ID:

NCT00005941

Start Date:

November 1999

Completion Date:

June 2005

Related Keywords:

  • Cervical Cancer
  • Vaginal Cancer
  • stage III cervical cancer
  • recurrent cervical cancer
  • stage IVB cervical cancer
  • stage IVA cervical cancer
  • stage III vaginal cancer
  • stage IVA vaginal cancer
  • stage IVB vaginal cancer
  • recurrent vaginal cancer
  • Uterine Cervical Neoplasms
  • Vaginal Neoplasms

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109