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NCT00300612 · ClinicalTrials.gov registry record · Phase 1
Vaccine Treatment for Advanced Malignant Melanoma
A Phase 1 study of Malignant Melanoma, sponsored by NewLink Genetics Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT00300612 is a Phase 1 study of Malignant Melanoma that has completed, run by NewLink Genetics Corporation. The registered enrollment target is 6 participants, below the 183-participant average among 28 other Malignant Melanoma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00300612, a Phase 1 study of Malignant Melanoma, has completed, sponsored by NewLink Genetics Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
This 2-phase study will determine the safety of treating patients with malignant melanoma with the genetically engineered HyperAcute-Melanoma vaccine. It will establish the proper vaccine dose and will examine side effects and potential benefits of the treatment. The vaccine contains killed melanoma cells containing a mouse gene that causes the production of a foreign pattern of protein-sugars on the cell surface. It is hoped that the immune response to the foreign substance will stimulate the immune system to attack the patient's own cancer cells that have similar proteins without this sugar pattern, causing the tumor to remain stable or shrink. Patients 18 years of age or older with malignant melanoma may be eligible for this study. Candidates will be screened with medical history and physical examination, blood tests, urinalysis, chest x-rays and CT scans. MRI, PET, and ultrasound scans may be obtained if needed. Participants will receive twelve vaccinations two weeks apart from each other. The vaccines will be injected under the skin, similar to the way a tuberculosis skin test is given. Phase I of the study will treat successive groups of patients with increasing numbers of the vaccine cells to evaluate side effects of the treatment and determine the optimum dose. Phase II will look for any beneficial effects of the vaccine given at the highest dose found to be safe in Phase I. Monthly blood samples will be drawn during the 6 months of vaccine treatment. In addition, patient follow-up visits will be scheduled every 3 months for the remaining first year (6 months) after vaccination and then every 6 months for the next 2 years for the following tests and procedures to evaluate treatment response and side effects: Medical history and physical examination Blood tests X-rays and various scans (nuclear medicine/CT/MRI) FACT-G Assessment questionnaire to measure the impact of treatment on the patient's general well-being. The questionnaire is administered before be
Conditions Studied
Interventions
- BIOLOGICAL HyperAcute-Melanoma Vaccine
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center & Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2006-03 |
| Est. Completion | 2007-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00300612
The ClinicalTrials.gov registry entry for NCT00300612 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 183-participant average among 28 other Malignant Melanoma trials with a reported enrollment target (97% lower). The listed sponsor is NewLink Genetics Corporation, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Malignant Melanoma appearing as the primary indexed condition, and to 1 intervention - of which HyperAcute-Melanoma Vaccine is the first listed.
NCT00300612 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT00300612 about?
NCT00300612 is a clinical study titled "Vaccine Treatment for Advanced Malignant Melanoma". This 2-phase study will determine the safety of treating patients with malignant melanoma with the genetically engineered HyperAcute-Melanoma vaccine. It will establish the proper vaccine dose and will examine side effects and potential benefits of the treatment. The vaccine contains killed melanoma...
What is the current status of trial NCT00300612?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2006-03. Estimated completion is 2007-09.
What conditions does trial NCT00300612 study?
This clinical trial studies the following conditions: Malignant Melanoma.
What interventions are being tested in trial NCT00300612?
The interventions under investigation include: HyperAcute-Melanoma Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00300612?
This trial is sponsored by NewLink Genetics Corporation, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00300612 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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