NCT00262886

Brief Summary

RATIONALE: A peripheral stem cell transplant or bone marrow transplant from a brother or sister may be an effective treatment for kidney cancer. PURPOSE: This phase II trial is studying how well a donor peripheral stem cell or bone marrow transplant works in treating patients with relapsed or refractory metastatic kidney cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 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

August 1, 2001

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Last Updated

June 6, 2013

Status Verified

June 1, 2013

Enrollment Period

5.9 years

First QC Date

December 6, 2005

Last Update Submit

June 5, 2013

Conditions

Kidney Cancer

Keywords

recurrent renal cell cancerstage IV renal cell cancer

Outcome Measures

Primary Outcomes (1)

  • Response rate based on tumor measurements at 1 year

Secondary Outcomes (2)

  • Toxicity as measured by NCI CTC at days 0, 7, 14, 21 and 28 after transplantation and monthly for 11 months

  • Overall and disease-free survival at day 100 and 1 year after transplantation

Interventions

anti-thymocyte globulinBIOLOGICAL
graft-versus-tumor induction therapyBIOLOGICAL
therapeutic allogeneic lymphocytesBIOLOGICAL
cyclophosphamideDRUG
fludarabine phosphateDRUG
mycophenolate mofetilDRUG
tacrolimusDRUG
allogeneic bone marrow transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic renal cell carcinoma * Relapsed or refractory disease * Tumor not amenable to complete surgical resection * No bone metastases only * No untreated brain metastases * Measurable disease * Available sibling donor who is HLA-identical or who has a mismatch at a single HLA locus (i.e., a 6/6 or 5/6 match at the HLA-A, -B, and -DR loci) PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin \< 3 mg/dL Renal * Creatinine \< 2 mg/dL * No untreated hypercalcemia Cardiovascular * LVEF ≥ 40% Pulmonary * DLCO ≥ 40% Other * Not pregnant or nursing * Fertile patients must use effective contraception * Negative pregnancy test * HIV-1 and -2 negative * No uncontrolled infection * No other active malignancy except basal skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: * At least 15 days since prior treatment for renal cell carcinoma * No other concurrent anticancer therapy

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

Sponsors & Collaborators

Study Sites (1)

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

Antilymphocyte SerumCyclophosphamidefludarabine phosphateMycophenolic AcidTacrolimusPeripheral Blood Stem Cell Transplantation

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)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex MixturesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsMacrolidesLactonesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • J. J. Ifthikharuddin, MD

    James P. Wilmot Cancer Center

    PRINCIPAL INVESTIGATOR

  • Jane L. Liesveld, MD

    James P. Wilmot Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 6, 2005

First Posted

December 7, 2005

Study Start

August 1, 2001

Primary Completion

July 1, 2007

Last Updated

June 6, 2013

Record last verified: 2013-06

Locations

US(1)