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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Partial or complete response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 64 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •Performance status:
- •Karnofsky 80-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Bilirubin no greater than 2 times upper limit of normal (ULN)
- •SGOT and SGPT no greater than 2 times ULN
- •Creatinine clearance at least 40 mL/min
- •Cardiovascular:
- •Cardiac ejection fraction at least 40%
- •No history of congestive heart failure
- •No poorly controlled hypertension
- •No severe defects in pulmonary function
- •No supplementary continuous oxygen
- •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
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Partial or complete response
次要结局
- Toxicity
- Engraftment and donor chimerism
- HPV-E6 and E7-specific T cell responses