Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005941
Status:
COMPLETED
Last Update Posted:
2010-04-02
First Post:
2000-07-05
Brief Title:
Peripheral Stem Cell Transplant White Blood Cell Infusions Chemotherapy and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients immune system from rejecting the donors stem cells The donated stem cells may replace the patients immune system and help destroy any remaining cancer cells graft-versus-tumor effect Giving an infusion of the donors 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 bodys 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FHCRC-147700 | None | None | None |
| NCI-G00-1784 | None | None | None |
| CDR0000067816 | REGISTRY | PDQ | None |