Vaccine Therapy in Treating Patients With Metastatic Kidney Cancer - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00019526

Purpose

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

PURPOSE: This randomized phase II trial is studying four different regimens of vaccine therapy and comparing how well they work in treating patients with metastatic kidney cancer.

Condition	Intervention	Phase
Kidney Cancer	Biological: aldesleukin Biological: incomplete Freund's adjuvant Biological: sargramostim Biological: von Hippel-Lindau peptide vaccine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Vaccine Therapy With Tumor Specific Mutated VHL Peptides in Adult Cancer Patients With Renal Cell Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer

Drug Information available for: Aldesleukin Sargramostim Freund's adjuvant

U.S. FDA Resources

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

Primary Outcome Measures:

Presence of endogenous cellular or humoral immunity [ Designated as safety issue: No ]
Induction of cellular immunity [ Designated as safety issue: No ]
Type and characteristics of cellular immunity [ Designated as safety issue: No ]
Tolerability [ Designated as safety issue: Yes ]
Toxicity [ Designated as safety issue: Yes ]
Feasibility of expanding specific T-cell clones [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	August 1999

Detailed Description:

OBJECTIVES:

Determine whether endogenous cellular or humoral immunity to a tumor-specific mutated von Hippel-Lindau (VHL) protein is present in patients with renal cell carcinoma.
Determine whether vaccination with synthetic peptide corresponding to the tumor's VHL mutation can induce or boost a patient's cellular immunity to that particular mutation.
Determine the type and characteristics of the cellular immunity generated in these patients.
Determine tolerance by the patients to this regimen.
Determine the toxicity spectrum of these peptides in these patients.
Determine the feasibility of expanding specific T-cell clones (peptide-activated lymphocytes) under guanosine monophosphate conditions.

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

Arm I (closed to accrual 12/31/01): Patients receive vaccination with peptide-pulsed antigen-presenting cells.
Arm II: Patients receive mutant von Hippel-Lindau (VHL) peptide vaccination emulsified with Montanide ISA-51 (ISA-51) subcutaneously (SC).
Arm III: Patients receive mutant VHL peptide and interleukin-2 emulsified with ISA-51 SC.
Arm IV: Patients receive VHL peptide and sargramostim (GM-CSF) emulsified with ISA-51 SC.

Vaccinations are repeated in each arm every 4 weeks for a total of 4 vaccinations. Patients with stable or responding disease receive 2 additional vaccinations and may repeat treatment every 4 weeks in the absence of disease progression or unacceptable toxicity. If there is disease progression with a specific immunologic response after 4 vaccinations, patients have the option of receiving 2 additional vaccinations.

Patients are followed at 2 months and then every 2 months until disease progression.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2-3 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed metastatic renal cell carcinoma for which there are no further chemotherapy or radiotherapy options known to increase survival
Must have tumor tissue available for determination of von Hippel-Lindau (VHL) mutation
- Must be found to have VHL mutation in tumor to receive treatment
No history of CNS metastases

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-1

Life expectancy:

More than 3 months

Hematopoietic:

WBC at least 2,000/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin no greater than 2.0 mg/dL
SGOT or SGPT no greater than 4 times normal
Hepatitis B and C negative

Renal:

Creatinine no greater than 2.0 mg/dL

Cardiovascular:

No active ischemic heart disease (New York Heart Association class III or IV cardiac disease)
No history of myocardial infarction within the last 6 months
No history of congestive heart failure
No ventricular arrhythmias or other arrhythmias requiring therapy

Immunologic:

No prior autoimmune neutropenia, thrombocytopenia, or hemolytic anemia
No prior systemic lupus erythematosus
No prior Sjögren's syndrome
No prior scleroderma
No prior myasthenia gravis
No prior Goodpasture's syndrome
No prior Addison's disease
No prior Hashimoto's thyroiditis
No prior rheumatoid arthritis
No prior multiple sclerosis
No active Graves' disease
HIV negative

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

See Disease Characteristics
At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

At least 4 weeks since prior steroids and recovered

Radiotherapy:

See Disease Characteristics
At least 4 weeks since prior radiotherapy and recovered

Surgery:

Surgical biopsy of tumor tissue allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019526

Locations

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

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Barry L. Gause, MD

National Cancer Institute (NCI)

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000066599, NCI-98-C-0139, NCI-T97-0081
Study First Received:	July 11, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00019526 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Urogenital Neoplasms
Urologic Neoplasms
Antiviral Agents
Pharmacologic Actions
Carcinoma

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

ClinicalTrials.gov processed this record on November 27, 2009