NCT00005941

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 1999

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

April 2, 2010

Status Verified

March 1, 2010

Enrollment Period

5.6 years

First QC Date

July 5, 2000

Last Update Submit

March 31, 2010

Conditions

Cervical CancerVaginal Cancer

Keywords

stage III cervical cancerrecurrent cervical cancerstage IVB cervical cancerstage IVA cervical cancerstage III vaginal cancerstage IVA vaginal cancerstage IVB vaginal cancerrecurrent vaginal cancer

Outcome Measures

Primary Outcomes (1)

  • Partial or complete response

Secondary Outcomes (3)

  • Toxicity

  • Engraftment and donor chimerism

  • HPV-E6 and E7-specific T cell responses

Interventions

therapeutic allogeneic lymphocytesBIOLOGICAL
cyclosporineDRUG
fludarabine phosphateDRUG
mycophenolate mofetilDRUG
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

AgeUp to 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsVaginal Neoplasms

Interventions

Cyclosporinefludarabine phosphateMycophenolic AcidPeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesVaginal Diseases

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsCaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Richard Nash, MD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2000

First Posted

January 27, 2003

Study Start

November 1, 1999

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

April 2, 2010

Record last verified: 2010-03

Locations

US(1)