Clinical Trial: Peripheral Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer

This study is currently recruiting patients.
Verified by National Cancer Institute (NCI) November 2006

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Cancer Institute (NCI) Identifier: NCT00003553


RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, before a donor peripheral blood 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). Giving an infusion of the donor’s T cells (donor lymphocyte infusion) after the transplant may help increase this effect.

PURPOSE: This phase II trial is studying how well peripheral stem cell transplant works in treating patients with metastatic kidney cancer.

Condition Intervention Phase
Kidney Cancer
 Drug: cyclophosphamide
 Drug: fludarabine phosphate
 Drug: therapeutic allogeneic lymphocytes
 Procedure: biological therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemotherapy
 Procedure: graft versus tumor induction
 Procedure: leukocyte therapy
 Procedure: peripheral blood lymphocyte therapy
 Procedure: peripheral blood stem cell transplantation
Phase II

MedlinePlus related topics:  Cancer;   Kidney Cancer
Genetics Home Reference related topics:  Cancer;   Kidney Cancer

Study Type: Interventional
Study Design: Treatment, Open Label

Official Title: A Phase II Study of HLA-Matched Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation for Metastatic Renal Cell Carcinoma Followed by Allogeneic T-Cell Infusion as Adoptive Immunotherapy

Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures: 
  • Graft vs tumor effect by CAT scan at days 30, 60, and 100 following transplant

Secondary Outcome Measures: 
  • Disease-free survival by CAT scan at 6 months and 1 year

Total Enrollment:  80


OUTLINE: This is a dose-escalation study of a conditioning regimen. (Dose escalation completed as of 10/1/03.)

Patients receive 1 of 3 dose levels of conditioning chemotherapy prior to peripheral blood progenitor cell (PBPC) transplantation. (Dose levels 2 and 3 are closed to accrual as of 10/1/03.)

Patients undergo mobilized CD34+ PBPC transplantation on day 0. PBPC transplantation may be repeated on days 1 and 2 if deemed necessary.

Patients with progressive disease on days 15-30, day 60, or day 100, without graft-versus-host disease, receive infusion(s) of donor lymphocytes. Further donor lymphocyte infusions after day 100 may be given at the discretion of the attending physician.

Patients are followed every 2 months for 6 months, every 3 months for 2 years, and then every 6 months for 2.5 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.


Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both


  • Histologically proven metastatic renal cell carcinoma not amenable to complete surgical resection and progressive despite immunotherapy
  • Bidimensionally evaluable clinically or radiographically
  • HLA 6/6 or 5/6 matched family donor available
  • No CNS metastases



  • 18 to 80

Performance status:

  • ECOG 0 or 1

Life expectancy:

  • At least 3 months


  • Not specified


  • Bilirubin no greater than 4 mg/dL
  • Transaminases no greater than 3 times upper limit of normal


  • Creatinine no greater than 2.5 mg/dL
  • No malignancy-associated hypercalcemia (< 2.5 mmol/L)


  • Left ventricular ejection fraction greater than 40%


  • DLCO greater than 65% of predicted


  • Not pregnant
  • HIV negative
  • No major organ dysfunction that would preclude transplantation
  • No other malignancies except basal cell or squamous cell skin cancer
  • No psychiatric disorder or mental deficiency that would preclude study participation


Biologic therapy

  • See Disease Characteristics


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • At least 1 month since prior treatment for renal cell carcinoma

Location and Contact Information

Please refer to this study by identifier  NCT00003553

United States, Maryland
      NIH - Warren Grant Magnuson Clinical Center, Bethesda,  Maryland,  20892-1182,  United States; Recruiting
Patient Recruitment  800-411-1222 

Study chairs or principal investigators

Richard W. Childs, MD,  Study Chair,  National Heart, Lung, and Blood Institute (NHLBI)   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database


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. Epub 2003 Oct 9.

Publications that report results of this study

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.

Study ID Numbers:  CDR0000066610; NHLBI-97-H-0196
Last Updated:  March 5, 2007
Record first received:  November 1, 1999 Identifier:  NCT00003553
Obsolete Identifier:   NCT00001635

Health Authority: Unspecified processed this record on May 14, 2007


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