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Peripheral Stem Cell Transplantation, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Peripheral Stem Cell Transplantation, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Peripheral Stem Cell Transplantation, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer Clinical research trials and Peripheral Stem Cell Transplantation, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Peripheral Stem Cell Transplantation, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer. Peripheral Stem Cell Transplantation, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Peripheral Stem Cell Transplantation, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer clinical trial. Test subjects typically obtain the finest healthcare available for their Peripheral Stem Cell Transplantation, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Peripheral Stem Cell Transplantation, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer  Peripheral Stem Cell Transplantation, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer
Peripheral Stem Cell Transplantation, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer
For Condition: Vaginal Cancer,Cervical Cancer
Status: Recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Donor peripheral stem cell transplantation and donor white blood cellinfusions may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells are rejected by the body's normal tissues. Mycophenolate mofetil and cyclosporine may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of donor peripheral stem cell transplantation plus chemotherapy and total-body irradiation followed by donor white blood cell infusion in treating patients who have recurrentmetastatic or locally advanced cancer of the cervix or vagina that is associated with human papillomavirus.
Details: OBJECTIVES: - 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 followed by allogeneic peripheral blood stem cell transplantation and donor lymphocyte infusion. - 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: 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. 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /64 Years
Genders: Both
Protocol 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 HLA genotypically 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardNash, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109-1024
United States
Recruiting Barbara Goff 206-288-2087
Additional Information:
Study ID Numbers: CDR0000067816; FHCRC-1477.00,NCI-G00-1784
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005941
Other Vaginal Cancer Studies:
1. Tretinoin in Preventing Cancer of the Cervix in Patients With Cervical Neoplasia
2. Epoetin beta in Treating Anemia in Patients With Cervical Cancer
3. Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer
4. Fenretinide in Treating Patients With Cervical Neoplasia
5. Gene Therapy in Treating Patients With Cancer
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Peripheral Stem Cell Transplantation, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer
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