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Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable 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: NCT00027573
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 14, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells.

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

Condition or disease Intervention/treatment Phase
Kidney Cancer Biological: filgrastim Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide Drug: fludarabine phosphate Drug: methotrexate Drug: tacrolimus Procedure: peripheral blood stem cell transplantation Phase 2

Detailed Description:


  • Determine the overall response rate and overall and disease-free survival of patients with unresectable or metastatic renal cell cancer treated with fludarabine and cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation.
  • Determine the toxicity and treatment-related mortality of this regimen in these patients.
  • Determine the percentage of donor chimerism in patients treated with this regimen.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adoptive Immunotherapy by Allogeneic Stem Cell Transplantation for Metastatic Renal Cell Carcinoma: A Phase II Study
Study Start Date : October 2001
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Arm Intervention/treatment
Experimental: Chemotherapy + stem cell transplantation

Patients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV over 1-2 hours on days -4 and -3. Allogeneic peripheral blood stem cells are infused on day 0. Patients then receive filgrastim (G-CSF) subcutaneously daily beginning on day 5 and continuing until blood counts recover.

Patients receive graft-versus-host disease (GVHD) prophylaxis comprising oral tacrolimus twice daily on days -1 to 90 and methotrexate IV on days 1, 3, and 6.

After day 120, patients with persistent disease and no signs of active GVHD may receive donor lymphocyte infusion (DLI). DLI may be repeated every 8 weeks for a total of 2 infusions.

Patients are followed every 2 months for 1 year and then every 6 months for 4 years OR every 2 months for 6 months and then every 6 months for 4.5 years if patient receives DLI.

Biological: filgrastim
Biological: therapeutic allogeneic lymphocytes
Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: methotrexate
Drug: tacrolimus
Procedure: peripheral blood stem cell transplantation

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: Up to 5 years ]
  2. Overall survival [ Time Frame: Up to 5 years ]
  3. Disease-free survival [ Time Frame: Up to 5 years ]
  4. Treatment-related mortality [ Time Frame: Up to 5 years ]
  5. Percentage of donor chimerism in patients treated [ Time Frame: Up to 5 years ]

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.

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Ages Eligible for Study:   up to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed renal cell carcinoma (RCC)

    • Clear cell or papillary RCC
    • Granular tumors with sarcomatoid features
    • No purely sarcomatoid RCC, chromophobic RCC, or oncocytoma
    • No transitional cell carcinoma of the renal pelvis and collecting systems
  • Metastatic or unresectable disease
  • At least 1 measurable lesion

    • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
    • The following are not considered measurable:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Lymphangitis cutis/pulmonis
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions
      • Primary bladder masses
  • Progressive disease after interferon alfa and/or interleukin-2 for metastatic RCC OR intolerance to these therapies
  • No prior or concurrent CNS metastases

    • Negative MRI of the brain within the past 28 days
  • Must have HLA-identical (6/6) sibling donor



  • 60 and under

Performance status:

  • ECOG 0-1

Life expectancy:

  • More than 6 months


  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST no greater than 3 times ULN


  • Creatinine clearance at least 40 mL/min


  • LVEF at least 45% by MUGA or echocardiogram


  • DLCO greater than 40% of predicted (corrected for hemoglobin level)
  • No symptomatic pulmonary disease


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No known hypersensitivity to E. coli-derived products
  • No uncontrolled diabetes mellitus
  • No active serious infection
  • No other concurrent malignancy except non-melanoma skin cancer or other malignancy that has less than a 30% risk of relapse after completion of therapy


Biologic therapy:

  • See Disease Characteristics
  • No concurrent sargramostim (GM-CSF)
  • Concurrent epoetin alfa allowed


  • No other concurrent chemotherapy

Endocrine therapy:

  • At least 28 days since prior hormonal therapy (e.g., megestrol, corticosteroids, or anti-estrogen therapy)
  • Concurrent steroids allowed for adrenal failure, graft-versus-host disease, or other nondisease-related conditions (e.g., insulin for diabetes)


  • At least 14 days since prior radiotherapy


  • At least 14 days since prior surgery


  • At least 28 days since prior systemic therapy for RCC
  • Recovered from prior therapy

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): NCT00027573

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United States, Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, New Jersey
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
United States, Oklahoma
CCOP - Oklahoma
Tulsa, Oklahoma, United States, 74136
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
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Study Chair: Brian I. Rini, MD University of California, San Francisco
Publications of Results:
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Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00027573    
Other Study ID Numbers: CALGB-90003
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000069044 ( Registry Identifier: NCI Physician Data Query )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Keywords provided by Alliance for Clinical Trials in Oncology:
stage IV renal cell cancer
recurrent renal cell cancer
clear cell renal cell carcinoma
papillary renal cell carcinoma
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urologic Diseases
Fludarabine phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic