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Vaccine Therapy With or Without Fludarabine in Treating Patients With Stage IV Kidney Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: October 6, 2004
Last updated: December 18, 2013
Last verified: May 2007

RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with fludarabine may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying vaccine therapy and fludarabine to see how well they work compared to vaccine therapy alone in treating patients with stage IV kidney cancer.

Condition Intervention Phase
Kidney Cancer
Biological: autologous tumor cell vaccine
Biological: keyhole limpet hemocyanin
Biological: therapeutic autologous dendritic cells
Drug: fludarabine phosphate
Procedure: conventional surgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Phase II Pilot Study of Tumor-Loaded Dendritic Cells Alone or Following a Non-Myeloablative Conditioning Regimen in Patients With Metastatic Renal Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety as measured by NCI common toxicity table at completion of study
  • Response as measured by RECIST guidelines and the Kaplan-Meier method at 5 years
  • Survival as measured by the Kaplan-Meier method at 5 years

Estimated Enrollment: 28
Study Start Date: August 2004
Detailed Description:



  • Compare the safety of vaccination comprising autologous dendritic cells loaded with autologous tumor lysate and keyhole limpet hemocyanin with vs without non-myeloablative fludarabine in patients with stage IV renal cell carcinoma.
  • Compare, preliminarily, the efficacy of these regimens in these patients.
  • Compare the overall survival of patients treated with these regimens.


  • Determine whether this vaccine induces tumor-reactive peripheral T-cell responses or delayed-type hypersensitivity in these patients.

OUTLINE: This is a pilot, randomized study. Patients are randomized to 1 of 2 treatment arms.

All patients undergo surgery to remove tumor at metastatic sites to generate autologous tumor lysate. Patients then undergo leukapheresis to obtain peripheral blood mononuclear cells for the generation of dendritic cells (DC). The DC are then exposed to autologous tumor lysate and keyhole limpet hemocyanin (KLH).

  • Arm I: Three weeks after leukapheresis, patients receive vaccination comprising DC loaded with autologous tumor lysate and KLH (DC vaccine) intradermally once every 14 days for a total of 4 injections in the absence of disease progression or unacceptable toxicity.
  • Arm II: Two weeks after leukapheresis, patients receive fludarabine IV over 15-30 minutes once daily for 3 days. Beginning approximately 5 weeks after leukapheresis, patients also receive DC vaccine as in arm I.

Patients are followed at 1, 3, and 7-9 weeks, at 4, 6, 9, and 12 months, and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 28 patients (14 per treatment arm) will be accrued for this study within 2-3 years.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed renal cell carcinoma

    • Stage IV disease
  • Received no benefit from standard therapy OR ineligible for standard therapy OR declined standard therapy
  • At least 1 site of metastatic disease that can be surgically removed AND at least 1 site of metastatic disease than can remain in the patient (indicator lesion) after surgery

    • Total volume of the site or sites of disease to be surgically removed must be > 2.0 cm^3
  • Unidimensionally measurable disease

    • At least 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No brain metastasis



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 6 months


  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 75,000/mm^3
  • Hemoglobin ≥ 10 g/dL


  • SGPT and SGOT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • Hepatitis C antibody negative
  • Hepatitis B surface antigen negative


  • Creatinine ≤ 1.5 times ULN
  • Creatinine clearance > 40 mL/min


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • Coomb's test negative
  • HIV-1 and -2 negative
  • No active infection
  • No unexplained fever (temperature > 100.5° F or 38.1°C)
  • No lymphocytopenia
  • No hypogammaglobulinemia
  • No autoimmune disease or other immunocompromising condition that would preclude study participation
  • No history of impaired immune response
  • No history of tuberculosis OR positive PPD skin test
  • No history of allergic reaction attributed to compounds of similar biological composition to study vaccine
  • No history of allergic reaction to antibiotics


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 month after study participation
  • No psychiatric illness or social situation that would preclude study participation
  • No other malignancy within the past 5 years except resected basal cell carcinoma or carcinoma in situ of the cervix
  • No other concurrent illness


Biologic therapy

  • More than 4 weeks since prior immunotherapy


  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

  • At least 4 weeks since prior steroid therapy or steroid-containing compounds
  • At least 2 weeks since prior topical or inhaled steroids


  • More than 4 weeks since prior radiotherapy


  • See Disease Characteristics


  • More than 4 weeks since prior investigational agents
  • More than 1 week since prior antibiotics
  • No concurrent renal dialysis
  • No concurrent anticoagulants
  • No other concurrent anticancer agents or therapies
  • No other concurrent investigational agents
  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: NCT00093522

United States, Wisconsin
Midwest Heart Surgery Institute, Limited
Milwaukee, Wisconsin, United States, 53215
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
St. Luke's Medical Center
Principal Investigator: John P. Hanson, MD St. Luke's Medical Center
  More Information Identifier: NCT00093522     History of Changes
Other Study ID Numbers: CDR0000389145
Study First Received: October 6, 2004
Last Updated: December 18, 2013

Keywords provided by National Cancer Institute (NCI):
recurrent renal cell cancer
stage IV renal cell cancer

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
Fludarabine phosphate
Keyhole-limpet hemocyanin
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Adjuvants, Immunologic processed this record on April 28, 2017