NCT00243009

Brief Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor 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). 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 transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving fludarabine together with total-body irradiation works in treating patients who are undergoing a donor stem cell transplant for metastatic kidney cancer that cannot be removed by surgery.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

May 28, 2012

Status Verified

June 1, 2010

Enrollment Period

10 months

First QC Date

October 20, 2005

Last Update Submit

May 24, 2012

Conditions

Kidney Cancer

Keywords

recurrent renal cell cancerstage IV renal cell cancerclear cell renal cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • Response rate (complete and partial response) at 6 and 12 months after transplantation

Secondary Outcomes (6)

  • Severity of graft-vs-host-disease by Glucksburg Scale after transplantation for up to 5 years

  • Incidence of graft rejection based on donor chimerims after transplantation for up to 5 years

  • Non-relapse mortality as assessed by Kaplan-Meier after transplantation for up to 5 years

  • Disease-free survival as assessed by Kaplan-Meier after transplantation for up to 5 years

  • Overall survival as assessed by Kaplan-Meier after transplantation for up to 5 years

  • +1 more secondary outcomes

Interventions

cyclosporineDRUG
fludarabine phosphateDRUG
mycophenolate mofetilDRUG
allogeneic bone marrow transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma, including 1 of the following subtypes: * Clear cell * Papillary * Medullary * Metastatic disease * Not amenable to curative surgery * No CNS metastases PATIENT CHARACTERISTICS: Performance status * Karnofsky 70-100% Life expectancy * More than 6 months Hematopoietic * Not specified Hepatic * Bilirubin \< 2 times upper limit of normal (ULN) * AST or ALT \< 4 times ULN Renal * Creatinine clearance \> 50 mL/min Cardiovascular * LVEF \> 35% * No symptomatic congestive heart failure Pulmonary * DLCO \> 40% of predicted OR * Total lung capacity or FEV\_1 \> 30% of predicted PRIOR CONCURRENT THERAPY: Biologic therapy * More than 30 days since prior biologic therapy Chemotherapy * More than 30 days since prior chemotherapy Radiotherapy * More than 30 days since prior radiotherapy

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

Sponsors & Collaborators

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

Cyclosporinefludarabine phosphateMycophenolic AcidPeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

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

  • Brandon M. Hayes-Lattin, MD

    OHSU Knight Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2005

First Posted

October 21, 2005

Study Start

June 1, 2005

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

May 28, 2012

Record last verified: 2010-06

Locations

US(1)