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NCT00080353 · ClinicalTrials.gov registry record · Phase 2
Vaccine Treatment in Combination With IL-2 and Treated Lymphocytes for Advanced Melanoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
NCT00080353: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00080353 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 58 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00080353, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
Study Summary
This study will examine the effectiveness of treating advanced melanoma with special tumor-fighting cells taken from the patient's blood or tumor and grown in the laboratory. The cells are given along with infusions of a growth factor-like substance called interleukin-2 (IL-2) and an experimental vaccine called fowlpox gp100. This vaccine consists of a peptide (part of a protein) called gp100 that is often found in melanoma tumors and chicken virus (fowlpox) that has been altered so that it cannot produce illness in humans. Patients 16 years of age and older with melanoma that has spread beyond the original site and that does not respond to standard treatment may be eligible for this study. Candidates are screened with a medical history and physical examination, chest x-ray, electrocardiogram, blood and urine tests, and x-rays and scans to the evaluate the extent and size of the tumor. Because the experimental preparation is based on tissue type, only patients with tissue type HLA-A\*0201 may participate. Tissue type is determined by a blood test. Participants undergo the following procedures: * Leukapheresis, a procedure for collecting lymphocytes (white blood cells): Using this procedure, special cells with good tumor-fighting ability are selected and removed for later re-infusion into the patient. To collect the cells, blood is withdrawn through a needle in an arm vein and directed through a catheter into a cell-separating machine. The lymphocytes are removed and the rest of the blood is returned to the body through the same needle. Alternatively, lymphocytes may also be collected from biopsied tumor tissue, obtained either with a needle or by a small cut in the tumor. * G-CSF injections: This growth factor is injected under the skin every day for 5 days to stimulate white blood cell production. * Catheter placement: Upon admission to the Clinical Center for treatment, the patient has a catheter (plastic tube) placed in a vein in the neck or arm for giving che
Interventions
- DRUG IL-2
- DRUG gp100:209-217
- DRUG OKT3
- DRUG rF-go 100P209
- DRUG Montanide ISA 51
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2004-03 |
| Est. Completion | 2008-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00080353
The ClinicalTrials.gov registry entry for NCT00080353 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 58 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 5 interventions - of which IL-2 is the first listed.
NCT00080353 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00080353 about?
NCT00080353 is a clinical study titled "Vaccine Treatment in Combination With IL-2 and Treated Lymphocytes for Advanced Melanoma". This study will examine the effectiveness of treating advanced melanoma with special tumor-fighting cells taken from the patient's blood or tumor and grown in the laboratory. The cells are given along with infusions of a growth factor-like substance called interleukin-2 (IL-2) and an experimental va...
What is the current status of trial NCT00080353?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2004-03. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00080353?
The interventions under investigation include: IL-2 (DRUG), gp100:209-217 (DRUG), OKT3 (DRUG), rF-go 100P209 (DRUG), Montanide ISA 51 (DRUG).
Who is sponsoring clinical trial NCT00080353?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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