COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Recurrent Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00025519
Recruitment Status : Withdrawn
First Posted : January 27, 2003
Last Update Posted : July 11, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fox Chase Cancer Center

Brief Summary:

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells. Sometimes the transplanted cells can be rejected by the body's tissues. Mycophenolate mofetil, tacrolimus, and donor white blood cells may prevent this from happening.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have metastatic or recurrent kidney cancer.

Condition or disease Intervention/treatment Phase
Kidney Cancer Biological: therapeutic allogeneic lymphocytes Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: tacrolimus Drug: thalidomide Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy Phase 2

Detailed Description:


  • Determine the feasibility of submyeloablative HLA-identical allogeneic peripheral blood stem cell transplantation in patients with metastatic or recurrent renal cell carcinoma.
  • Determine the toxicity of this regimen, in terms of incidence and severity of graft rejection, acute graft-vs-host disease (GVHD), chronic GVHD, adverse effects from the preparative regimen and thalidomide, and infection and bleeding, in these patients.
  • Determine the efficacy of this regimen, in terms of objective partial and complete response rates, in these patients.
  • Determine the engraftment rates and extent of chimerism in patients treated with this regimen.
  • Determine the overall survival and time to treatment failure rate in patients treated with this regimen.
  • Determine the impact of thalidomide on the treatment of chronic GVHD in patients treated with this regimen.

OUTLINE: Patients are stratified according to risk (low vs high).

Patients receive fludarabine IV over 30 minutes once daily on days -4 to -2 followed by total body irradiation on day -1. Patients receive tacrolimus IV over 24 hours or orally daily on days -3 to 35 and oral mycophenolate mofetil twice daily on days -3 to 28 as graft-vs-host disease (GVHD) prophylaxis. Patients undergo allogeneic peripheral blood stem cell transplantation over 1-2 hours on day 0.

Patients maintaining a mixed chimerism with no evidence of grade III or IV GVHD receive donor lymphocyte infusions (DLI) on days 60, 90, and 120. Patients may receive additional DLI as needed. Patients with limited chronic GVHD receive oral thalidomide daily beginning after day 80 and continuing for 1 year or until disease progression or resolution of chronic GVHD.

Patients are followed at 1, 3, 6, and 12 months and then every 6 months thereafter.

PROJECTED ACCRUAL: A maximum of 20-40 patients (10-20 per stratum) will be accrued for this study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Submyeloablative Allogeneic Blood Stem Cell Transplantation With HLA Identical Donor Lymphocyte Infusions From Matched Related and Matched Unrelated Donors for Treatment of Metastatic Renal Cell Carcinoma
Study Start Date : June 2001
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed renal cell carcinoma (RCC)

    • Histology demonstrates major clear cell component
    • Metastatic (stage IV) or recurrent disease
  • Prior debulking nephrectomy required

    • Disease not amenable to complete surgical resection
  • Must have HLA-identical donor

    • Matched related sibling donors must have 6/6 serologic HLA A, B, and DR match with molecular confirmation at DRB1

      • A 5/6 serologic mismatch with one antigen mismatch at locus A or B (not DR) with molecular confirmation at locus A, B, and DRB1 allowed
    • Matched unrelated donors must have a minimum of 8 out of 10 molecular matches at loci A, B, C, DRB1, and DQB1
  • No brain metastases

    • Negative MRI required



  • 18 to 65

Performance status:

  • Karnofsky 80-100% OR
  • ECOG 0-1

Life expectancy:

  • Not specified


  • Not specified


  • Bilirubin less than 2 times upper limit of normal (ULN)
  • ALT/AST less than 2 times ULN
  • Alkaline phosphatase less than 2 times ULN
  • Hepatitis A, B, and C negative


  • Creatinine clearance greater than 50 mL/min
  • Calcium less than 10.5 mg/dL (bisphosphonates allowed)


  • LVEF no less than 10% below lower limit of normal


  • FEV_1 and DLCO greater than 50%


  • HIV negative
  • No active bacterial, fungal, or viral (including cytomegalovirus) infections
  • No intolerance or allergy to tacrolimus, mycophenolate mofetil, or fludarabine
  • No intolerance to 200 cGy of total body irradiation
  • No other serious comorbid disease, neurologic condition, or psychosocial condition that would preclude study follow-up
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for at least 1 month before, during, and for at least 3 months after study participation


Biologic therapy:

  • Prior interleukin-2 allowed
  • Prior interferon alfa allowed


  • Prior chemotherapy allowed
  • No other concurrent chemotherapy for RCC

Endocrine therapy:

  • No concurrent corticosteroids for other comorbid disease


  • No prior extensive radiotherapy to marrow microenvironment greater than 20% of total marrow mass
  • No prior radiotherapy that has reached tissue tolerance for heart, lung, liver, kidney, or spinal cord


  • See Disease Characteristics


  • No other concurrent therapy for RCC
  • No concurrent enrollment on another investigational protocol for treatment of RCC
  • No other concurrent immunosuppressive medications
  • No other concurrent investigational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00025519

Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Gary R. Hudes, MD Fox Chase Cancer Center
Layout table for additonal information
Responsible Party: Fox Chase Cancer Center Identifier: NCT00025519    
Other Study ID Numbers: FCCC-01006
CDR0000068970 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013
Keywords provided by Fox Chase Cancer Center:
stage IV renal cell cancer
recurrent renal cell cancer
clear cell renal cell carcinoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Mycophenolic Acid
Fludarabine phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents