Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed Under 65 NCI FHCRC-1477.00 NCI-G00-1784, NCT00005941

Objectives

Primary

1. 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

1. Determine the toxicity of this regimen in these patients.
2. Determine whether this regimen induces engraftment and donor chimerism in these patients.
3. Determine the HPV-E6 and HPV-E7 specific T-cell responses in selected patients treated with this regimen.

Entry 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

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

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

Expected Enrollment

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

Outcomes

Partial or complete response

Toxicity
Engraftment and donor chimerism
HPV-E6 and E7-specific T cell responses

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.

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center

Richard Nash, MD, Protocol chair		Ph: 206-667-4978

Registry Information
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
Trial Start Date		1999-11-24
Registered in ClinicalTrials.gov		NCT00005941
Date Submitted to PDQ		2000-03-24
Information Last Verified		2005-08-20
NCI Grant/Contract Number		P30-CA15704, R21-CA89931

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