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

Get the latest research information from NIH: Menu

Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Metastatic 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: NCT00004135
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 7, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Chicago

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 plus peripheral stem cell transplantation in treating patients who have metastatic kidney cancer or melanoma.

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

Detailed Description:


  • Evaluate the safety of nonmyeloablative chemotherapy followed by allogeneic peripheral blood stem cell transplantation in patients with metastatic renal cell carcinoma or melanoma.
  • Determine the incidence and severity of all adverse events related to this treatment regimen in this patient population.
  • Determine the efficacy of this treatment regimen in terms of tumor regression, response duration, progression free survival, and overall survival in these patients.
  • Measure the resulting chimerism and immune reconstitution in these patients after this treatment regimen and correlate with clinical response.

OUTLINE: Patients receive fludarabine IV over 30 minutes on days -8 through -4 and cyclophosphamide IV over 1 hour on days -3 and -2. Immediately following each daily donor leukapheresis, patients receive allogeneic peripheral blood stem cells (PBSC) IV over 15 minutes beginning on day 0 and continuing until the target cells are collected. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 5 and continuing until blood counts recover.

If no graft versus host disease has developed within 4 weeks of allogeneic PBSC transplantation, patients with disease progression or recurrence who have residual donor hematopoiesis on chimerism analysis may receive donor T lymphocytes IV over 30 minutes. Patients may receive an additional course of donor T lymphocytes at the investigator's discretion.

Patients are followed at days 30 and 100, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 10-38 patients will be accrued for this study within 2.5 years.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Allogeneic Stem Cell Transplantation of Renal Cell Cancer and Metastatic Melanoma After Non-Myeloablative Chemotherapy
Study Start Date : February 1999
Actual Primary Completion Date : October 2004
Actual Study Completion Date : August 2007

Arm Intervention/treatment
Experimental: Arm A
Fludarabine 30 mg/m2/d x S days IVPB in 100 cc NS over 30 minutes on day -8, -7, -6, -S, and -4. Cyclophosphamide 2 gm/m2/d x 2 days IVPB in SOO cc DS W over I hour on day -3 and day-2. G-CSF (Neupogen®) administration 480 f!gld subcutaneously starting on day +5 (or first day of neutropenia if earlier)and continued until an ANC of 0.5 x 109/L is maintained for 3 consecutive days.
Biological: filgrastim
Biological: therapeutic allogeneic lymphocytes
Drug: cyclophosphamide
Drug: fludarabine phosphate
Procedure: peripheral blood stem cell transplantation

Primary Outcome Measures :
  1. Complete Response Rate [ Time Frame: 3 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.

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 metastatic renal cell carcinoma or melanoma that is not potentially curable by surgery
  • Evaluable disease or bidimensionally measurable disease on physical examination, chest x-ray, CT scan, or MRI

    • Measurable disease by radiography must be reproducible
    • Bony disease or effusions not measurable
  • No active CNS disease currently receiving radiotherapy or steroids
  • No effusion or ascites of more than 1 liter prior to drainage
  • HLA 5/6 or 6/6 matched sibling donor available

    • No known hypersensitivity to E. coli derived products
    • No active infection
    • No health condition that would preclude donation



  • 18 to 65

Performance status:

  • CALGB 0-2

Life expectancy:

  • Not specified


  • Not specified


  • Bilirubin no greater than 2.0 g/dL
  • No active hepatitis


  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance greater than 50 mL/min


  • LVEF at least 50%


  • DLCO at least 50% of predicted


  • No active infection
  • HIV negative
  • No psychological problem that would preclude study compliance
  • No known hypersensitivity to E. coli derived products
  • Not pregnant or nursing
  • Negative pregnancy test


Biologic therapy:

  • Not specified


  • At least 4 weeks since prior systemic chemotherapy

Endocrine therapy:

  • See Disease Characteristics


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy


  • See Disease Characteristics

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): NCT00004135

Layout table for location information
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Todd M. Zimmerman, MD University of Chicago
Layout table for additonal information
Responsible Party: University of Chicago Identifier: NCT00004135    
Other Study ID Numbers: 9672
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 7, 2014
Last Verified: March 2014
Keywords provided by University of Chicago:
stage IV renal cell cancer
recurrent renal cell cancer
stage IV melanoma
recurrent melanoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Germ Cell and Embryonal
Kidney Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Glandular and Epithelial
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