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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 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.

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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.

Conditions Studied

Sarcoma

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

FieldValue
Enrollment Target 136 participants
Start Date 2010-06
Est. Completion 2017-03-10
Phase Phase 2

Sponsor

MabVax Therapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01141491

The ClinicalTrials.gov registry entry for NCT01141491 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 920-participant average among 122 other Sarcoma trials with a reported enrollment target (85% lower). The listed sponsor is MabVax Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 13 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.