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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclosporine; Cyclosporins; Fludarabine; Fludarabine phosphate; Mycophenolate mofetil; Mycophenolic Acid

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