NCT00318110

Brief Summary

The purpose of this study is to find out what effects (good and bad) a stem cell transplant from an unrelated donor will have for patients with kidney cancer that has spread to other parts of the body (metastasized).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2006

Typical duration for phase_2

Geographic Reach
1 country

5 active sites

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

April 1, 2006

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

2.9 years

First QC Date

April 24, 2006

Last Update Submit

July 25, 2016

Conditions

Metastatic Renal Cell Carcinoma

Keywords

MetastaticRenalCellCarcinomaUnrelatedDonorTransplantstage IVclear cell

Outcome Measures

Primary Outcomes (1)

  • Determine the best rate of tumor response of complete response (CR) + complete unconfirmed response (CRU) + partial response (PR) within 6 months after matched unrelated donor (MUD) nonmyeloablative stem cell transplantation (NST)

    6 months

Secondary Outcomes (6)

  • Overall survival after MUD NST

    Two years

  • Rate of complete donor myeloid and lymphoid chimerism after MUD NST

    One year

  • Incidence and severity of acute and chronic graft-versus-host disease (GvHD) after MUD NST

    Two years

  • Incidence of treatment-related mortality (TRM)

    100 Days

  • Assess cytotoxic T-lymphocyte reactivity

    One year

  • +1 more secondary outcomes

Study Arms (1)

MUD treatment

EXPERIMENTAL

NST using MUD for metastatic renal cell carcinoma

Procedure: NST using MUD for metastatic renal cell carcinoma

Interventions

NST using MUD for metastatic renal cell carcinomaPROCEDURE

Preparative regimen: Fludarabine 25 mg/m2 IV once a day x 5 days (-6,-5,-4,-3,-2) Melphalan 70 mg/m2 IV once a day x 2 days (-3,-2) Donor Stem Cell Infusion: Stem cells will be infused on day 0 GVHD prophylaxis: Tacrolimus and methotrexate 5 mg/m2 IV day 1, 3, 6 and 11

MUD treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of metastatic (stage IV) renal cell carcinoma (RCC) predominately clear cell type
  • Prior nephrectomy
  • Available HLA-matched (8/8, 7/8) unrelated donor
  • At least one prior immunotherapy; or immunotherapy + chemotherapy; or targeted therapy, for metastatic RCC.
  • Adequate organ function

You may not qualify if:

  • Prior allogeneic stem cell transplantation
  • RCC with histology other than clear cell type
  • History or presence of brain metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of California - Los Angeles

Los Angeles, California, 90095, United States

Location

Shands - University of Florida

Gainesville, Florida, 32610, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Renal CellNeoplasm MetastasisCarcinoma

Condition Hierarchy (Ancestors)

AdenocarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Naoto Ueno, M.D., Ph.D.

    MDACC

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

April 24, 2006

First Posted

April 26, 2006

Study Start

April 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

July 26, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Only 2 subjects enrolled prior to study closure due to slow accrual.

Locations

US(5)