Vaccine Therapy in Treating Patients With Stage III or Stage IV Kidney Cancer - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00091403

Purpose

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage III or stage IV kidney cancer.

Condition	Intervention	Phase
Kidney Cancer	Biological: HLA-A2, A3-restricted FGF-5 peptides/Montanide ISA-51 vaccine Biological: aldesleukin Procedure: adjuvant therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Immunization of Patients With Renal Cancer Using HLA-A2 and HLA-A3-Binding Peptides From Fibroblast Growth Factor 5 (FGF-5)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer

Drug Information available for: Aldesleukin

U.S. FDA Resources

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

Primary Outcome Measures:

Clinical response (cohorts A and B) [ Designated as safety issue: No ]
Immunological response (cohort C) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Immunological response (cohorts A and B) [ Designated as safety issue: No ]

Estimated Enrollment:	210
Study Start Date:	August 2004
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine the overall response rates in patients with stage IV clear cell renal cell carcinoma treated with vaccine comprising HLA-A2- and HLA-A3-binding peptides from fibroblast growth factor-5 emulsified in Montanide ISA-51. (Cohorts A and B)
Determine the effect of this vaccine on the response rate to high-dose interleukin-2 in these patients. (Cohorts A and B)
Determine the immunologic response in patients with stage III clear cell renal cell carcinoma at high risk for relapse treated with this vaccine. (Cohort C)
Determine the toxicity of this vaccine in these patients.

Secondary

Determine the immunologic response in patients with stage IV disease treated with this vaccine. (Cohorts A and B)

OUTLINE: Patients are stratified according to class I haplotype (HLA-A2 vs HLA-A3). Patients are assigned to 1 of 3 cohorts.

Cohort A (no requirement for immediate interleukin-2 [IL-2] therapy): Patients receive vaccination comprising the HLA-appropriate binding peptide from fibroblast growth factor-5 (FGF-5) emulsified in Montanide ISA-51 subcutaneously (SC) once daily on days 1-4. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

At the time of disease progression, patients eligible for IL-2 who have not yet received it have high-dose IL-2 added to their regimen. Patients continue to receive peptide vaccination on days 1-4 and receive high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 (12 doses). Treatment repeats every 15-19 days for up to 1 year of total treatment.

Cohort B (requirement for immediate IL-2 therapy): Patients receive vaccination comprising the HLA-appropriate binding peptide from FGF-5 emulsified in Montanide ISA-51 SC once daily on days 1-4. Patients also receive high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 (12 doses). Treatment repeats every 15-19 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Cohort C: Patients receive peptide vaccination as in cohort A. At the time of relapse, patients have high-dose IL-2 added to their regimen as in cohort A. Treatment repeats every 15-19 days for up to 6 months of total treatment.

Patients are followed every 3-6 months (cohorts A and B) OR every 3 months for 1 year and then every 6-12 months thereafter (cohort C).

PROJECTED ACCRUAL: A total of 36-210 patients (12-80 in cohort A, 12-66 in cohort B, and 12-64 in cohort C) will be accrued for this study within 5 years.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed clear cell renal cell carcinoma meeting one of the following criteria:
- Measurable metastatic disease (cohorts A and B)
  - Tumor site must be safely accessible for biopsy OR have indications for resection of a tumor site (e.g., indicated nephrectomy or symptomatic metastasis)
- Stage III primary tumor (i.e., T3 or T4 OR N1 or N2) removed within the past 6 months AND at high-risk for recurrence (cohort C)
Detectable fibroblast growth factor-5 tumor expression by reverse transcription polymerase chain reaction
Patients must be HLA-A2- or HLA-A3-positive

PATIENT CHARACTERISTICS:

Age

16 and over

Performance status

ECOG 0-1

Life expectancy

More than 3 months

Hematopoietic

WBC ≥ 3,000/mm^3
Platelet count ≥ 90,000/mm^3
No coagulation disorders

Hepatic

AST and ALT < 3 times normal
Bilirubin ≤ 1.6 mg/dL (< 3.0 mg/dL for patients with Gilbert's disease)
Hepatitis B surface antigen negative
Hepatitis C antibody negative (unless antigen negative)

Renal

Creatinine ≤ 2.0 mg/dL

Cardiovascular

Cardiac stress test normal in patients with EKG abnormalities, symptoms of cardiac ischemia, arrhythmias, or > 50 years old*
No cardiac ischemia*
No myocardial infarction*
No cardiac arrhythmias*
No other major medical illness of the cardiovascular system NOTE: *Eligibility for IL-2 administration

Pulmonary

FEV_1 > 60% of predicted for patients with prolonged history of cigarette smoking or symptoms of respiratory dysfunction*
No obstructive or restrictive pulmonary disease*
No other major medical illness of the respiratory system NOTE: *Eligibility for IL-2 administration

Immunologic

HIV negative
No active systemic infections
No known immunodeficiency disease
- Immune competence is defined as lymphocyte count > 500/mm^3, WBC ≥ 1,000/mm^3, and no opportunistic infections
No known allergic reaction to Montanide ISA-51
No hypersensitivity to any agent used in this study

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for at least 3 months after study participation
Willing or able to undergo biopsy
No other active major medical illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

Prior low-dose interleukin-2 (IL-2) (less than 600,000 IU/kg) allowed

Chemotherapy

More than 6 weeks since prior nitrosoureas

Endocrine therapy

No concurrent systemic steroid therapy

Radiotherapy

Local radiotherapy within the past 3 weeks allowed

Surgery

See Disease Characteristics
Minor surgical procedures within the past 3 weeks allowed

Other

Recovered from all prior therapy
More than 3 weeks since any other prior therapy for the malignancy
No other concurrent therapy for the malignancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091403

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

James C. Yang, MD

NCI - Surgery Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Web site for additional information This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000386241, NCI-04-C-0259, NCI-6622
Study First Received:	September 7, 2004
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00091403 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

stage III renal cell cancer
stage IV renal cell cancer
clear cell renal cell carcinoma

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Antineoplastic Agents
Urogenital Neoplasms
Urologic Neoplasms
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Aldesleukin
Anti-Retroviral Agents
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010