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NCT01141491 · ClinicalTrials.gov registry record · Phase 2
Trivalent Ganglioside Vaccine With Immunological Adjuvant or Immunological Adjuvant Alone in Metastatic Sarcoma Patients Who Are Rendered Disease Free
A Phase 2 study of Sarcoma, sponsored by MabVax Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 136
- Enrollment target
- 13
- Study locations
NCT01141491: Completed Phase 2 study of Sarcoma, sponsored by MabVax Therapeutics.
NCT01141491 is a Phase 2 study of Sarcoma that has completed, run by MabVax Therapeutics. The registered enrollment target is 136 participants, below the 920-participant average among 122 other Sarcoma trials with a reported enrollment target (85% lower). The trial reports 13 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01141491, a Phase 2 study of Sarcoma, has completed, sponsored by MabVax Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 136 participants
- Enrollment target
- 13
- Study locations
Study Summary
Sarcoma patients are at high risk for their cancer to recur even when the sarcoma has been removed surgically or treated with radiation or chemotherapy. The patients in the study will be randomized (like flipping a coin) to receive either a vaccine that is combined with an immune system stimulant or the immune system stimulant alone. The immune system stimulant is called OPT-821 and is an immunological booster. The trivalent vaccine is being developed to teach the patient's immune system to recognize 3 types of sugars called GM2, GD2 and GD3 that are found primarily on the surface of sarcoma cells. If the trivalent vaccine can stimulate the patient's immune system to develop antibodies which recognize and target the GM2, GD2 and GM3 sugars, then the patient's antibodies could attack and kill any remaining sarcoma cells potentially preventing the recurrence of sarcoma.
Primary Outcome
The primary objective is to compare the progression-free survival (PFS) over time. Progression free survival is defined as the time from randomization until any evidence of tumor growth or appearance anywhere in the body or death from any cause as determined by the principal investigator at each site. The principal investigator will determine Progression-free survival by using CT scans to evaluate disease recurrence. For the purpose of this study, progression of disease is defined as the develo
Conditions Studied
Interventions
- BIOLOGICAL OPT-821
- BIOLOGICAL Trivalent ganglioside vaccine
Study Locations (13)
California
- UCLA Medical Center - Los Angeles
Colorado
- University of Colorado (Denver) - Denver
Georgia
- Winship Cancer Institute at Emory Midtown - Atlanta
Illinois
- Northwestern University - Robert H. Lurie Comprehensive Cancer Center - Chicago
Iowa
- University of Iowa Hospitals and Clinic - Iowa City
Massachusetts
- Dana Farber Cancer Institute - Boston
Michigan
- University of Michigan Hospital - Ann Arbor
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2010-06 |
| Est. Completion | 2017-03-10 |
| Phase | Phase 2 |
What the finished NCT01141491 record still lists
NCT01141491 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 920-participant average among 122 other Sarcoma trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Sarcoma appearing as the primary indexed condition, and to 2 interventions - of which OPT-821 is the first listed.
NCT01141491 lists 13 locations in 13 states (California, Colorado, Georgia).
Frequently Asked Questions
What is clinical trial NCT01141491 about?
NCT01141491 is a clinical study titled "Trivalent Ganglioside Vaccine With Immunological Adjuvant or Immunological Adjuvant Alone in Metastatic Sarcoma Patients Who Are Rendered Disease Free". Sarcoma patients are at high risk for their cancer to recur even when the sarcoma has been removed surgically or treated with radiation or chemotherapy. The patients in the study will be randomized (like flipping a coin) to receive either a vaccine that is combined with an immune system stimulant or...
What is the current status of trial NCT01141491?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 136 participants. The study started on 2010-06. Estimated completion is 2017-03-10.
What conditions does trial NCT01141491 study?
This clinical trial studies the following conditions: Sarcoma.
What interventions are being tested in trial NCT01141491?
The interventions under investigation include: OPT-821 (BIOLOGICAL), Trivalent ganglioside vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01141491?
This trial is sponsored by MabVax Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01141491 being conducted?
This trial has 13 study locations across California, Colorado, Georgia, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01141491's enrollment target sits among peer trials
136 36th of 122 higher than 87 of 122 other Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sarcoma 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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