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

Primary Purpose

Kidney Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
autologous tumor cell vaccine
keyhole limpet hemocyanin
therapeutic autologous dendritic cells
fludarabine phosphate
conventional surgery
Sponsored by
St. Luke's Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage IV renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy More than 6 months Hematopoietic WBC ≥ 3,000/mm^3 Platelet count ≥ 75,000/mm^3 Hemoglobin ≥ 10 g/dL Hepatic 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 Renal Creatinine ≤ 1.5 times ULN Creatinine clearance > 40 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Immunologic 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 Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior immunotherapy Chemotherapy 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 Radiotherapy More than 4 weeks since prior radiotherapy Surgery See Disease Characteristics Other 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

Sites / Locations

  • Midwest Heart Surgery Institute, Limited
  • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
October 6, 2004
Last Updated
December 18, 2013
Sponsor
St. Luke's Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00093522
Brief Title
Vaccine Therapy With or Without Fludarabine in Treating Patients With Stage IV Kidney Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
St. Luke's Medical Center

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
OBJECTIVES: Primary 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. Secondary 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
recurrent renal cell cancer, stage IV renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
autologous tumor cell vaccine
Intervention Type
Biological
Intervention Name(s)
keyhole limpet hemocyanin
Intervention Type
Biological
Intervention Name(s)
therapeutic autologous dendritic cells
Intervention Type
Drug
Intervention Name(s)
fludarabine phosphate
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Primary Outcome Measure Information:
Title
Safety as measured by NCI common toxicity table at completion of study
Title
Response as measured by RECIST guidelines and the Kaplan-Meier method at 5 years
Title
Survival as measured by the Kaplan-Meier method at 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy More than 6 months Hematopoietic WBC ≥ 3,000/mm^3 Platelet count ≥ 75,000/mm^3 Hemoglobin ≥ 10 g/dL Hepatic 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 Renal Creatinine ≤ 1.5 times ULN Creatinine clearance > 40 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Immunologic 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 Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior immunotherapy Chemotherapy 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 Radiotherapy More than 4 weeks since prior radiotherapy Surgery See Disease Characteristics Other 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P. Hanson, MD
Organizational Affiliation
St. Luke's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Midwest Heart Surgery Institute, Limited
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

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

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