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NCT00398138 · ClinicalTrials.gov registry record · Phase 1

Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma

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

Completed
Registry status
Phase 1
Development phase
22
Enrollment target

NCT00398138: Completed Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.

NCT00398138 is a Phase 1 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00398138, a Phase 1 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
22 participants
Enrollment target

Study Summary

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill cancer cells. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop cancer cells from growing. Giving vaccine therapy together with GM-CSF may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects of vaccine therapy and GM-CSF in treating patients with acute myeloid leukemia, myelodysplastic syndromes, non-small cell lung cancer, or mesothelioma.

Primary Outcome

Toxicities will be tabulated according to the NCI Common Toxicity (version 3.0).

Interventions

  • GENETIC polymerase chain reaction
  • OTHER flow cytometry
  • BIOLOGICAL sargramostim
  • BIOLOGICAL incomplete Freund's adjuvant
  • BIOLOGICAL WT-1 analog peptide vaccine

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2006-10
Est. Completion 2009-06
Phase Phase 1
Memorial Sloan Kettering Cancer Center

1,884 total trials

What the finished NCT00398138 record still lists

NCT00398138 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).

The record links to 0 conditions, and to 5 interventions - of which polymerase chain reaction is the first listed.

NCT00398138 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00398138 about?

NCT00398138 is a clinical study titled "Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma". RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill cancer cells. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop cancer cells from growing. Giving vaccine therapy together with GM-CSF may kill more canc...

What is the current status of trial NCT00398138?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2006-10. Estimated completion is 2009-06.

What interventions are being tested in trial NCT00398138?

The interventions under investigation include: polymerase chain reaction (GENETIC), flow cytometry (OTHER), sargramostim (BIOLOGICAL), incomplete Freund's adjuvant (BIOLOGICAL), WT-1 analog peptide vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00398138?

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 NCT00398138's enrollment target sits among peer trials

22 1601st of 2000 higher than 386 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 NCT00398138, the US trial registry maintained by the National Library of Medicine. NCT00398138 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.