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NCT00059475 · ClinicalTrials.gov registry record · Phase 2
Peptide Vaccination for Patients at High Risk for Recurrent Melanoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 138
- Enrollment target
NCT00059475: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00059475 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 138 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00059475, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 138 participants
- Enrollment target
Study Summary
This study will examine the effectiveness and side effects of an experimental vaccine to prevent recurrence of melanoma. The likelihood of melanoma returning is higher in patients who have melanoma lesions deep in the skin, in patients who have had positive lymph nodes, and in patients who have had surgery for metastatic disease (cancer that has spread beyond the primary site). Melanoma tumors produce proteins called glycoprotein 100 (gp100) and melanoma-associated antigen recognized by T cells 1 (MART-1). Vaccination with specific pieces of these proteins (peptides) may boost the immune system's fight against the cancer. The vaccine injections are mixed with an oil-based substance called Montanide ISA-51, which is intended to increase the immune response to the peptide. Patients 16 years of age and older whose melanoma has been surgically removed and who are currently free of disease may be eligible for this study. Candidates will be screened with a physical examination and blood and urine tests. An electrocardiogram (EKG), x-rays and other imaging studies will be done if recent results are not available. Some candidates may require heart tests, such as a cardiac stress test or echocardiogram, or lung function tests. In addition, all candidates will be tested for human leukocyte antigen (HLA) tissue type; patients must be type human leukocyte antigens (HLA-A)\*0201, the type on which this vaccine is based. Participants will be randomly assigned to receive one of four different vaccines to determine which peptides offer the best immunity. Each treatment course consists of two injections of the vaccines every 3 weeks for four times. The injections are given under the skin of the thigh. After every other treatment course (every 6 months), patients will undergo a series of x-rays and scans to look for tumor. The immunizations may continue for up to 12 months as long as the melanoma does not return. The injections are given at the National Institutes of Health (NIH) C
Interventions
- DRUG Interleukin-2 (IL-2)
- DRUG Montanide ISA 51
- DRUG Glycoprotein 100 (GP100): 209-217 (210M)
- DRUG Melanoma antigen recognized by T-cells (MART)-1: 27-35
- DRUG 27-35 (27L): melanoma antigen recognized by T-cells (MART)-1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2003-04 |
| Est. Completion | 2010-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00059475
The ClinicalTrials.gov registry entry for NCT00059475 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 138 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 Interleukin-2 (IL-2) is the first listed.
NCT00059475 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00059475 about?
NCT00059475 is a clinical study titled "Peptide Vaccination for Patients at High Risk for Recurrent Melanoma". This study will examine the effectiveness and side effects of an experimental vaccine to prevent recurrence of melanoma. The likelihood of melanoma returning is higher in patients who have melanoma lesions deep in the skin, in patients who have had positive lymph nodes, and in patients who have had ...
What is the current status of trial NCT00059475?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 138 participants. The study started on 2003-04. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00059475?
The interventions under investigation include: Interleukin-2 (IL-2) (DRUG), Montanide ISA 51 (DRUG), Glycoprotein 100 (GP100): 209-217 (210M) (DRUG), Melanoma antigen recognized by T-cells (MART)-1: 27-35 (DRUG), 27-35 (27L): melanoma antigen recognized by T-cells (MART)-1 (DRUG).
Who is sponsoring clinical trial NCT00059475?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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