NCT00003553

Brief Summary

RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, before a donor peripheral blood stem cell transplant helps stop the growth of tumor cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining tumor 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 with or without mycophenolate mofetil or methotrexate after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well peripheral stem cell transplant works in treating patients with metastatic kidney cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 1998

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 9, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2011

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

13.4 years

First QC Date

November 1, 1999

Last Update Submit

June 18, 2020

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancerrecurrent renal cell cancer

Outcome Measures

Primary Outcomes (1)

  • The anti-tumor effect of allogenic peripheral blood stem cell transplantation in patients with progressive metastatic renal cell carcinoma.

    5 Years

Secondary Outcomes (2)

  • Evaluate the safety and toxicity of a nonmyeloblative, low intensity, preparative regimen followed by an HLA matched allogenic peripheral blood stem cell transplant in patients with metastatic renal cell carcinoma.

    100 Days

  • The relationship between donor-host chimerism and the incidence of acute and chronic GVHD. The effect of donor lymphocyte infusions on donor-host chimerism. Response rate, disease free and overall survival and mortality.

    100 days

Study Arms (1)

1

EXPERIMENTAL

The target for progenitor cell is \>=5 x 106 CD 34/kg.

Other: HLA Matched Peripheral BLood Stem Cells

Interventions

HLA Matched Peripheral BLood Stem CellsOTHER

Cell Product

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18-80 years.
  • Biopsy proven metastatic RCC, not amenable to complete surgical resection, progressive bidimensionally evaluable clinically or radiographically.
  • No prior treatment for RCC within 30 days.
  • HIV negative.
  • ECOG performance status of 1 or less.
  • No major organ dysfunction precluding transplantation.
  • DLCO greater than or equal to 65% predicted.
  • Left ventricular ejection fraction greater than or equal to 40%.
  • HLA 6/6 or 5/6 matched family related donor available.
  • Ability to comprehend the investigational nature of the study and provide informed consent.
  • Durable power of attorney signed.
  • HLA 6/6 or 5/6 matched family related donor.
  • Fit to receive G-CSF and give peripheral blood stem cells (normal blood counts, normotensive, no history of stroke).
  • Ability to comprehend the investigational nature of the study and provide informed consent.
  • Ages 18-80.

You may not qualify if:

  • Patient Pregnant.
  • Age greater than 80 or less than 18 years.
  • ECOG performance status of 2 or more. Psychiatric disorder or mental deficiency of the patient or donor sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.
  • Major anticipated illness or organ failure incompatible with survival from BMT where survival is considered insufficient to assess transplant outcome (i.e. less than 3 months).
  • DLCO less than 65% predicted.
  • Left ventricular ejection fraction less than 40%.
  • Serum creatinine greater than 2.5mg/dl or creatinine clearance less than 50 cc/min by 24 hour urine collection.
  • Serum bilirubin greater than 4 mg/dl, transaminases greater than 3 x upper limit of normal.
  • HIV positive.
  • History of other malignancies except basal cell or squamous carcinoma of the skin.
  • Disease which is limited and amenable to complete surgical resection.
  • Lack of evidence for progressive disease.
  • Disease which is not evaluable clinically or radiographically.
  • Evidence for CNS metastatic disease.
  • Disease involving greater than 25% of the liver radiographically.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIH - Warren Grant Magnuson Clinical Center

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (2)

  • Carvallo C, Geller N, Kurlander R, Srinivasan R, Mena O, Igarashi T, Griffith LM, Linehan WM, Childs RW. Prior chemotherapy and allograft CD34+ dose impact donor engraftment following nonmyeloablative allogeneic stem cell transplantation in patients with solid tumors. Blood. 2004 Feb 15;103(4):1560-3. doi: 10.1182/blood-2003-04-1170. Epub 2003 Oct 9.

    PMID: 14551148BACKGROUND

  • Childs R, Chernoff A, Contentin N, Bahceci E, Schrump D, Leitman S, Read EJ, Tisdale J, Dunbar C, Linehan WM, Young NS, Barrett AJ. Regression of metastatic renal-cell carcinoma after nonmyeloablative allogeneic peripheral-blood stem-cell transplantation. N Engl J Med. 2000 Sep 14;343(11):750-8. doi: 10.1056/NEJM200009143431101.

    PMID: 10984562RESULT

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

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

Study Officials

  • Richard W. Childs, MD

    National Heart, Lung, and Blood Institute (NHLBI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: patients with progressive metastatic renal cell carcinoma.
Sponsor Type
NIH

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

February 9, 1998

Primary Completion

June 27, 2011

Study Completion

June 27, 2011

Last Updated

June 19, 2020

Record last verified: 2020-06

Locations

US(1)