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NCT01248273 · ClinicalTrials.gov registry record · Phase 1

Unimolecular Pentavalent (Globo-H-GM2-sTn-TF-Tn) Immunization of Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer in First Remission

A Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.

Completed
Registry status
Phase 1
Development phase
26
Enrollment target

NCT01248273: Completed Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.

NCT01248273 is a Phase 1 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01248273, a Phase 1 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
26 participants
Enrollment target

Study Summary

The purpose of this study is to 1) test the safety of the vaccine to find out what effects, good and/or bad, it has, and 2) to find out if the vaccine stimulates the immune system. The vaccine in this study will contain several parts. The first part is called an antigen. These antigens or "fingerprints" are found on many cancer cells, especially from the ovaries, fallopian tubes, or peritoneal cavity (inside lining of the abdomen) The purpose of this study is to see if investigators can help the immune system to recognize that cancer cells are not normal and should be removed.

Primary Outcome

immunization with the unimolecular pentavalent carbohydrate-based vaccine bearing Globo-H, GM2, sTn, TF and Tn on a single polypeptide backbone, conjugated to KLH, mixed with the immunological adjuvant QS-21, induces an IgG and IgM antibody response against these individual antigens and tumor cells expressing these antigens.

Interventions

  • BIOLOGICAL Globo-H-GM2-sTn-TF-Tn-KLH conjugate, plus the immunological adjuvant QS-21

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2010-11
Est. Completion 2017-03
Phase Phase 1
Memorial Sloan Kettering Cancer Center

1,884 total trials

What the finished NCT01248273 record still lists

NCT01248273 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).

The record links to 0 conditions, and to 1 intervention - of which Globo-H-GM2-sTn-TF-Tn-KLH conjugate, plus the immunological adjuvant QS-21 is the first listed.

NCT01248273 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01248273 about?

NCT01248273 is a clinical study titled "Unimolecular Pentavalent (Globo-H-GM2-sTn-TF-Tn) Immunization of Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer in First Remission". The purpose of this study is to 1) test the safety of the vaccine to find out what effects, good and/or bad, it has, and 2) to find out if the vaccine stimulates the immune system. The vaccine in this study will contain several parts. The first part is called an antigen. These antigens or "fingerpri...

What is the current status of trial NCT01248273?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2010-11. Estimated completion is 2017-03.

What interventions are being tested in trial NCT01248273?

The interventions under investigation include: Globo-H-GM2-sTn-TF-Tn-KLH conjugate, plus the immunological adjuvant QS-21 (BIOLOGICAL).

Who is sponsoring clinical trial NCT01248273?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01248273's enrollment target sits among peer trials

26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01248273, the US trial registry maintained by the National Library of Medicine. NCT01248273 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.