Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer

This study has been completed.
Southwest Oncology Group
Eastern Cooperative Oncology Group
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: December 7, 2001
Last updated: February 6, 2009
Last verified: April 2004

December 7, 2001
February 6, 2009
October 2001
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00027573 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer
Adoptive Immunotherapy by Allogeneic Stem Cell Transplantation for Metastatic Renal Cell Carcinoma: A Phase II Study

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.


  • 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.

OUTLINE: 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.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 18-24 months.

Phase 2
Primary Purpose: Treatment
Kidney Cancer
  • Biological: filgrastim
  • Biological: therapeutic allogeneic lymphocytes
  • Drug: cyclophosphamide
  • Drug: fludarabine phosphate
  • Drug: methotrexate
  • Drug: tacrolimus
  • Procedure: peripheral blood stem cell transplantation
Not Provided
Rini BI, Halabi S, Barrier R, Margolin KA, Avigan D, Logan T, Stadler WM, McCarthy PL, Linker CA, Small EJ; Cancer and Leukemia Group B; Eastern Cooperative Oncology Group; Southwestern Oncology Group. Adoptive immunotherapy by allogeneic stem cell transplantation for metastatic renal cell carcinoma: a CALGB intergroup phase II study. Biol Blood Marrow Transplant. 2006 Jul;12(7):778-85.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
Not Provided
Not Provided


  • 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
up to 60 Years
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000069044, CALGB-90003, ECOG-CALGB-C90003, SWOG-CALGB-C90003
Not Provided
Not Provided
Cancer and Leukemia Group B
  • National Cancer Institute (NCI)
  • Southwest Oncology Group
  • Eastern Cooperative Oncology Group
Study Chair: Brian I. Rini, MD University of California, San Francisco
Study Chair: David Avigan, MD Beth Israel Deaconess Medical Center
National Cancer Institute (NCI)
April 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP