Trial · NCT00398138
Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma
NCT00398138, Phase 1, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2016-03-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma. Trials, record NCT00398138. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00398138
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma
- NCT number
- NCT00398138
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 22 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Leukemia, Lung Cancer, Malignant Mesothelioma, Myelodysplastic Syndromes, Primary Peritoneal Cavity Cancer
- Interventions
- WT-1 analog peptide vaccine, incomplete Freund's adjuvant, sargramostim, polymerase chain reaction, flow cytometry, immunoenzyme technique
- First posted
- 2006-11-10
- Last updated
- 2016-03-02
- Results first posted
- 2016-03-02
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety | 2 years | Toxicities will be tabulated according to the NCI Common Toxicity (version 3.0). |
| Primary | Immune Response | 2 years | Immune reactivity to the peptides will be measured in the same fashion for patients with hematologic or thoracic malignancies. Immune responses will be measured by T cell proliferative response and DTH against WT-1 peptides. In patients with adequate samples, T cell gamma interferon release as measured by ELISPOT will be performed as well. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety | 2 years | participants | NUMBER | |
| PRIMARY | Immune Response | 2 years | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety | Vaccine | 10 | participants | ||
| Immune Response | Vaccine | 10 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vaccine | 12 | |
| Overall Study | COMPLETED | Vaccine | 10 | |
| Overall Study | NOT COMPLETED | Vaccine | 2 |
Source ClinicalTrials.gov
Adverse events11
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Albumin, low (hypoalbuminemia) | Metabolism and nutrition disorders | Vaccine | 6 | 10 | |
| other | Fatigue (asthenia, lethargy, malaise) | General disorders | Vaccine | 4 | 10 | |
| other | Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | Vaccine | 10 | 10 | |
| other | Hemoglobin | Metabolism and nutrition disorders | Vaccine | 6 | 10 | |
| other | Leukocytes (total WBC) | Infections and infestations | Vaccine | 4 | 10 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Vaccine | 1 | 10 | |
| other | Neutrophils/granulocytes (ANC/AGC) | Infections and infestations | Vaccine | 2 | 10 | |
| other | Platelets | Blood and lymphatic system disorders | Vaccine | 4 | 10 | |
| serious | Dyspnea | Respiratory, thoracic and mediastinal disorders | Vaccine | 2 | 10 | 2 |
| serious | Edema: head and neck | Vascular disorders | Vaccine | 1 | 10 | 1 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vaccine | ||
| Total, other adverse events | Vaccine | 10 | 10 |
| Total, serious adverse events | Vaccine | 3 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20400682 | RESULT |
Source PubMed
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA008748 | Cancer Center Support Grant | Rudin, Charles M. | SLOAN-KETTERING INST CAN RESEARCH | NATIONAL CANCER INSTITUTE | 1985 to 2026 | NIH RePORTER |
| P01CA023766 | Immunobiology of Allogeneic Hematopoietic Cell Transplantation | SCHEINBERG, DAVID A | SLOAN-KETTERING INST CAN RESEARCH | NATIONAL CANCER INSTITUTE | 1985 to 2023 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00398138
GET https://conductscience.org/api/trials/v1/NCT00398138/registered