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

Primary Purpose

Cervical Cancer, Vaginal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
therapeutic allogeneic lymphocytes
cyclosporine
fludarabine phosphate
mycophenolate mofetil
peripheral blood stem cell transplantation
radiation therapy
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring 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

Eligibility Criteria

undefined - 64 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fred Hutchinson Cancer Research Center

Outcomes

Primary Outcome Measures

Partial or complete response

Secondary Outcome Measures

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

Full Information

First Posted
July 5, 2000
Last Updated
March 31, 2010
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005941
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
November 1999 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Vaginal Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
therapeutic allogeneic lymphocytes
Intervention Type
Drug
Intervention Name(s)
cyclosporine
Intervention Type
Drug
Intervention Name(s)
fludarabine phosphate
Intervention Type
Drug
Intervention Name(s)
mycophenolate mofetil
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Partial or complete response
Secondary Outcome Measure Information:
Title
Toxicity
Title
Engraftment and donor chimerism
Title
HPV-E6 and E7-specific T cell responses

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Nash, MD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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