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NCT00089778 · ClinicalTrials.gov registry record · Phase 2
Vaccine Treatment of Kidney Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT00089778: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00089778 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 11 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00089778, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
This study will evaluate the safety and side effects of two experimental vaccines in patients with kidney cancer and determine whether the vaccines "turn on" an immune response to the cancer. Each vaccine contains one of two peptides (pieces of proteins) from the fibroblast growth factor 5 (FGF-5) antigen, a protein produced by some cancer cells, and an oil-based liquid called Incomplete Freud's Adjuvant (Montanide ISA-51) that enhances the immune response to the vaccine. Patients 16 years of age and older who have kidney cancer that has spread beyond the kidney or whose primary kidney tumor has been removed within 6 months before entering the study and are at high risk for disease recurrence may be eligible for this study. Patients must have tissue type human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2) or human leukocyte antigen serotype within HLA-A A serotype group (HLA-A3) (determined by a blood test for human leukocyte antigen (HLA) typing) and their tumors must produce the FGF-5 peptide. Candidates are screened with a physical examination, blood and urine tests, electrocardiogram (EKG), tumor biopsy (removal of a small sample of tumor for examination) in patients whose tumor is easily accessible, and scans (computed tomography (CT), bone scans) and x-rays if current scans are not available. Participants are divided into two groups according to their HLA type (HLA-A2 or HLA-A3) to receive the vaccine appropriate for their HLA type. They are then further divided into three groups: 1) Group 1 includes patients who do not need or are ineligible for treatment with interleukin-2 (IL-2), a protein made by certain infection-fighting white cells that helps fight tumors) and patients who have previously had IL-2 therapy; 2) Group 2 includes patients who require immediate treatment with IL-2; and 3) Group 3 includes patients whose cancer has been surgically removed but who are at risk for recurrence. Patients in Groups 1 and 3 receive two peptide
Interventions
- DRUG 117-126:Fibroblast growth factor 5 (FGF-5)
- DRUG Fibroblast growth factor 5 (FGF-5):172-176/217-220
- OTHER IL-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2004-09-10 |
| Est. Completion | 2008-08-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00089778
The ClinicalTrials.gov registry entry for NCT00089778 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which 117-126:Fibroblast growth factor 5 (FGF-5) is the first listed.
NCT00089778 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00089778 about?
NCT00089778 is a clinical study titled "Vaccine Treatment of Kidney Cancer". This study will evaluate the safety and side effects of two experimental vaccines in patients with kidney cancer and determine whether the vaccines "turn on" an immune response to the cancer. Each vaccine contains one of two peptides (pieces of proteins) from the fibroblast growth factor 5 (FGF-5) a...
What is the current status of trial NCT00089778?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2004-09-10. Estimated completion is 2008-08-05.
What interventions are being tested in trial NCT00089778?
The interventions under investigation include: 117-126:Fibroblast growth factor 5 (FGF-5) (DRUG), Fibroblast growth factor 5 (FGF-5):172-176/217-220 (DRUG), IL-2 (OTHER).
Who is sponsoring clinical trial NCT00089778?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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