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NCT00118274 · ClinicalTrials.gov registry record · Phase 1
Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma
A Phase 1 study of Melanoma (Skin), sponsored by Craig L Slingluff, Jr.
- Completed
- Registry status
- Phase 1
- Development phase
- 170
- Enrollment target
- 3
- Study locations
NCT00118274: Completed Phase 1 study of Melanoma (Skin), sponsored by Craig L Slingluff, Jr.
NCT00118274 is a Phase 1 study of Melanoma (Skin) that has completed, run by Craig L Slingluff, Jr. The registered enrollment target is 170 participants, above the 131-participant average among 30 other Melanoma (Skin) trials with a reported enrollment target (30% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00118274, a Phase 1 study of Melanoma (Skin), has completed, sponsored by Craig L Slingluff, Jr.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 170 participants
- Enrollment target
- 3
- Study locations
Study Summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cyclophosphamide may also stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with cyclophosphamide after surgery may cause a stronger immune response to kill any remaining tumor cells. It may also prevent or delay the recurrence of melanoma. PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy when given with or without cyclophosphamide and to see how well they work in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.
Primary Outcome
Number of participants with dose-limiting toxicities
Conditions Studied
Interventions
- DRUG cyclophosphamide
- BIOLOGICAL incomplete Freund's adjuvant
- BIOLOGICAL melanoma helper peptide vaccine
- BIOLOGICAL multi-epitope melanoma peptide vaccine
- BIOLOGICAL tetanus toxoid helper peptide
Study Locations (3)
Pennsylvania
- Fox Chase Cancer Center - Philadelphia - Philadelphia
Texas
- M. D. Anderson Cancer Center at University of Texas - Houston
Virginia
- University of Virginia Cancer Center - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2005-03 |
| Est. Completion | 2010-02 |
| Phase | Phase 1 |
What the finished NCT00118274 record still lists
NCT00118274 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, above the 131-participant average among 30 other Melanoma (Skin) trials with a reported enrollment target (30% higher).
The record links to 1 condition, with Melanoma (Skin) appearing as the primary indexed condition, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00118274 reports a single indexed study location in Pennsylvania, Texas, Virginia.
Frequently Asked Questions
What is clinical trial NCT00118274 about?
NCT00118274 is a clinical study titled "Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma". RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cyclophospha...
What is the current status of trial NCT00118274?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 170 participants. The study started on 2005-03. Estimated completion is 2010-02.
What conditions does trial NCT00118274 study?
This clinical trial studies the following conditions: Melanoma (Skin).
What interventions are being tested in trial NCT00118274?
The interventions under investigation include: cyclophosphamide (DRUG), incomplete Freund's adjuvant (BIOLOGICAL), melanoma helper peptide vaccine (BIOLOGICAL), multi-epitope melanoma peptide vaccine (BIOLOGICAL), tetanus toxoid helper peptide (BIOLOGICAL).
Who is sponsoring clinical trial NCT00118274?
This trial is sponsored by Craig L Slingluff, Jr, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00118274 being conducted?
This trial has 3 study locations across Pennsylvania, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Melanoma (Skin)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00118274's enrollment target sits among peer trials
170 7th of 30 higher than 24 of 30 other Melanoma (Skin) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma (Skin) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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