NCT00429026

Brief Summary

Primary Objectives:

  1. 1.To compare the overall survival of metastatic renal cell carcinoma (RCC) patients undergoing HLA-matched related donor nonmyeloablative allogeneic hematopoietic stem cell transplantation (NST) using fludarabine-melphalan (FM) versus fludarabine-cyclophosphamide (FC) conditioning regimen.
  2. 2.To assess both cytotoxic T lymphocyte reactivity and antibodies activity against potential tumor antigenic peptides involved in graft-versus-RCC effect.
  3. 3.To study the patient characteristics of metastatic RCC patients who undergo NST and those who do not undergo NST.
  4. 4.To compare the incidence of Day-100 treatment-related mortality in FM group and FC group.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2004

Typical duration 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

January 1, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

July 13, 2009

Completed
Last Updated

March 4, 2013

Status Verified

February 1, 2013

Enrollment Period

4.2 years

First QC Date

January 29, 2007

Results QC Date

February 26, 2009

Last Update Submit

February 26, 2013

Conditions

Renal Cell Cancer

Keywords

Kidney CancerRenal Cell CancerStem Cell TransplantCyclophosphamideFludarabineMelphalanNST

Outcome Measures

Primary Outcomes (1)

  • Survival Rate

    Number of participants surviving at 4 years compared to total participants, to compare the overall survival of metastatic renal cell carcinoma (RCC) patients undergoing HLA-matched related donor nonmyeloablative allogeneic hematopoietic stem cell transplantation (NST) using fludarabine-melphalan (FM) versus fludarabine-cyclophosphamide (FC) conditioning regimen. Evaulation after 1, 2, 3, 6, 9, \& 12 months, then every 4 months for 4 years.

    Up to 4 years

Study Arms (2)

Fludarabine + Cyclophosphamide with ASCT

EXPERIMENTAL

ASCT=Allogeneic Hematopoietic Stem Cell Transplantation

Drug: FludarabineDrug: CyclophosphamideProcedure: Stem Cell Transplant

Fludarabine + Melphalan with ASCT

EXPERIMENTAL

ASCT=Allogeneic Hematopoietic Stem Cell Transplantation

Drug: FludarabineDrug: MelphalanProcedure: Stem Cell Transplant

Interventions

FludarabineDRUG

25 mg/m\^2 intravenous (IV) daily for 5 Days

Fludarabine + Cyclophosphamide with ASCTFludarabine + Melphalan with ASCT
MelphalanDRUG

70 mg/m\^2 IV Daily for 2 Days

Fludarabine + Melphalan with ASCT
CyclophosphamideDRUG

60 mg/kg IV Daily for 2 Days

Fludarabine + Cyclophosphamide with ASCT
Stem Cell TransplantPROCEDURE

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using HLA-Matched Related Donor

Also known as: ASCT
Fludarabine + Cyclophosphamide with ASCTFludarabine + Melphalan with ASCT

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • For registration: Willing to undergo allogeneic transplantation.
  • For registration: Age equal to or less than 65 years old.
  • For registration: Metastatic RCC with predominant conventional cell type.
  • For registration: Prior nephrectomy.
  • For registration: Stage IV RCC. If patient has prior single brain metastasis treated with complete surgical resection or stereotactic radiation therapy, no recurrence or brain edema from the end of treatment for at least 6 months has to be shown by radiological imaging.
  • For registration: Zubrod performance status \< one.
  • For registration: Potential related donor for allogeneic stem cell transplantation.
  • For registration: At least one prior treatment for metastatic RCC. Radiation therapy or surgery is not counted as a treatment.
  • For registration: Signed an informed consent.
  • For transplantation: Zubrod performance status \< one.
  • For transplantation: An HLA-matched (defined as 6/6 matches) related donor.
  • For transplantation: Failed at least one prior treatment for metastatic RCC. Radiation therapy or surgery is not counted as a treatment.
  • For transplantation: Adequate major organ functions (see section 4.17-4.20).
  • For transplantation: Signed an informed consent for allogeneic stem cell transplantation.

You may not qualify if:

  • For registration: Prior history of allogeneic stem cell transplantation.
  • For registration: Histologic feature with predominant non-conventional cell type.
  • For registration: Multiple brain metastasis.
  • For registration: Life expectancy is severely limited by concomitant illness.
  • For transplantation: Multiple brain metastasis.
  • For transplantation: Life expectancy is severely limited by concomitant illness.
  • For transplantation: Clinically significant active infections.
  • For transplantation: HIV infection.
  • For transplantation: Chronic active hepatitis
  • For transplantation: Pregnant or lactating women.
  • For transplantation: Has all three risk factors: high serum lactate dehydrogenase, low hemoglobin, high corrected serum calcium.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Renal CellKidney Neoplasms

Interventions

fludarabineMelphalanCyclophosphamideStem Cell Transplantation

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsPhosphoramide MustardsPhosphoramidesOrganophosphorus CompoundsCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Limitations and Caveats

Primary outcome measure was not assessed due to early study termination, e.g. patients did not receive assigned treatment.

Results Point of Contact

Title
Naoto Ueno, MD, PhD / Associate Professor
Organization
U.T. M.D. Anderson Cancer Center
CR_Study_Registration@mdanderson.org
713-792-8754

Study Officials

  • Naoto Ueno, MD, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2007

First Posted

January 31, 2007

Study Start

January 1, 2004

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

March 4, 2013

Results First Posted

July 13, 2009

Record last verified: 2013-02

Locations

US(1)