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

This study has been withdrawn prior to enrollment.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fox Chase Cancer Center Identifier:
First received: October 11, 2001
Last updated: July 10, 2013
Last verified: July 2013

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 Intervention 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

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:

Further study details as provided by Fox Chase Cancer Center:

Enrollment: 0
Study Start Date: June 2001
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00025519

Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)
Study Chair: Gary R. Hudes, MD Fox Chase Cancer Center
  More Information

Responsible Party: Fox Chase Cancer Center Identifier: NCT00025519     History of Changes
Other Study ID Numbers: FCCC-01006
CDR0000068970 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: October 11, 2001
Last Updated: July 10, 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:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Mycophenolate mofetil
Fludarabine phosphate
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors processed this record on April 21, 2017