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NCT01435499 · ClinicalTrials.gov registry record · Phase 1
Safety Study of a Melanoma Vaccine (GVAX) With or Without Cyclophosphamide in Patients With Surgically Resected Melanoma
A Phase 1 study of Melanoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT01435499: Completed Phase 1 study of Melanoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT01435499 is a Phase 1 study of Melanoma that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 21 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01435499, a Phase 1 study of Melanoma, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study is to evaluate the safety and feasibility of administering an allogeneic GM-CSF-secreting lethally irradiated whole melanoma cell vaccine ("melanoma GVAX"), alone or in combination with low dose cyclophosphamide (CPM), for the adjuvant treatment of patients with surgically resected stage IIB-IV melanoma. Secondarily, the investigators will assess in vitro correlates of anti-melanoma immunization by melanoma GVAX, including serological and cellular immune responses in patients treated with either the vaccine alone or the vaccine given with low dose CPM.
Primary Outcome
To determine the side effects and tolerability of administering an allogeneic GM-CSF-secreting lethally irradiated whole melanoma cell vaccine ("melanoma GVAX"), alone or in combination with low dose cyclophosphamide, for the adjuvant treatment of patients with surgically resected stage IIB-IV melanoma.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- BIOLOGICAL melanoma GVAX
Study Locations (1)
Maryland
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2011-09 |
| Est. Completion | 2016-03 |
| Phase | Phase 1 |
What the finished NCT01435499 record still lists
NCT01435499 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Cyclophosphamide is the first listed.
NCT01435499 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01435499 about?
NCT01435499 is a clinical study titled "Safety Study of a Melanoma Vaccine (GVAX) With or Without Cyclophosphamide in Patients With Surgically Resected Melanoma". The primary objective of this study is to evaluate the safety and feasibility of administering an allogeneic GM-CSF-secreting lethally irradiated whole melanoma cell vaccine ("melanoma GVAX"), alone or in combination with low dose cyclophosphamide (CPM), for the adjuvant treatment of patients with s...
What is the current status of trial NCT01435499?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2011-09. Estimated completion is 2016-03.
What conditions does trial NCT01435499 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT01435499?
The interventions under investigation include: Cyclophosphamide (DRUG), melanoma GVAX (BIOLOGICAL).
Who is sponsoring clinical trial NCT01435499?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01435499 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01435499's enrollment target sits among peer trials
21 226th of 266 higher than 39 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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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