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NCT00273910 · ClinicalTrials.gov registry record · Phase 2
Evaluation of the Impact of Adjuvants Accompanying Peptide Immunization in High-Risk Melanoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
NCT00273910: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00273910 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 104 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00273910, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
Study Summary
This study will evaluate the immunization effects of a vaccine for patients who are at risk for recurrence of their skin cancer. That is, the risk of cancer is higher if melanoma has invaded deep into the skin or lymph nodes. Currently, the only therapy that the U.S. Food and Drug Administration (FDA) has approved for preventing recurrence of melanoma is alpha-interferon. But the research data are controversial. In this study, the vaccine to be used, called gp100, contains a piece of a protein called a peptide, which melanoma cancer cells produce. Patients 16 and older who have had confirmed melanoma surgically removed and whose tissue type is tested as being human leukocyte antigen serotype within HLA-A serotype group (HLA-A2), through a specific blood test, may be eligible for this study. Up to 132 participants will be enrolled. There will be a physical examination and collection of blood samples for tests, and making sure that x-rays and scans are current. Patients will be randomly assigned to four groups. Group 1 will receive the peptide with an adjuvant (assistant) oil-based liquid called Montanide ISA-51, as an injection in the thigh. Group 2 will receive gp100, Montanide, and a cream called imiquimod, which the FDA has approved for treating genital warts and herpes but that may help immune cells in the skin to recognize the vaccine. Imiquimod will be applied to the skin for 5 days. Group 3 will receive gp100 mixed in salt water given as several mini-doses under the skin of the thigh. Group 4 will also receive several mini-doses of gp100 mixed in saline, as well as imiquimod cream applied to the skin for 5 days. All patients will receive the gp100 every 3 weeks for 12 weeks. Every dose is a cycle, with four cycles considered a course of therapy. If the melanoma does not return or patients do not experience side effects from this therapy, then the courses of vaccine will repeated for up to 12 cycles of therapy (3 courses over 33 weeks). Side effects of the pe
Interventions
- DRUG Imiquimod
- DRUG gp100:209-217 (210M)
- DRUG Montanide ISA-51
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2006-01 |
| Est. Completion | 2010-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00273910
The ClinicalTrials.gov registry entry for NCT00273910 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 104 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 Imiquimod is the first listed.
NCT00273910 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00273910 about?
NCT00273910 is a clinical study titled "Evaluation of the Impact of Adjuvants Accompanying Peptide Immunization in High-Risk Melanoma". This study will evaluate the immunization effects of a vaccine for patients who are at risk for recurrence of their skin cancer. That is, the risk of cancer is higher if melanoma has invaded deep into the skin or lymph nodes. Currently, the only therapy that the U.S. Food and Drug Administration (FD...
What is the current status of trial NCT00273910?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2006-01. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00273910?
The interventions under investigation include: Imiquimod (DRUG), gp100:209-217 (210M) (DRUG), Montanide ISA-51 (DRUG).
Who is sponsoring clinical trial NCT00273910?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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