Trial · NCT00924287
Gene Therapy Using Anti-Her-2 Cells to Treat Metastatic Cancer
NCT00924287, Phase 1, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2012-02-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gene Therapy Using Anti-Her-2 Cells to Treat Metastatic Cancer. Trials, record NCT00924287. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00924287
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gene Therapy Using Anti-Her-2 Cells to Treat Metastatic Cancer
- NCT number
- NCT00924287
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Metastatic Cancer
- Interventions
- in vitro tumor reactive, chimeric T cell receptor (CAR ) gene-transduced PBL plus IV aldesleukin, Cyclophosphamide, Fludarabine, Mesna
- First posted
- 2009-06-18
- Last updated
- 2015-10-28
- Results first posted
- 2012-02-14
- Limitations and caveats
- This study was terminated after the first patient on study died as a result of the treatment.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With an Objective Clinical Tumor Regression Response | 12 days | Response Evaluation Criteria in Solid Tumors (RECIST) are used to determine objective clinical response. Complete Rresponse (CR) is the disappearance of all target lesions, partial response (PR) is at least a 30% decrease in the target lesions, progressive disease (PD) is at least a 20% increase in the target lesions or appearance of one or more new lesions, and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
| Primary | Number of Participants With Adverse Events | 12 days | Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. |
| Secondary | Number of Participants With In Vivo Survival of Transfused Cells | 12 days | In-vivo survival of infused cells is determined by analysis of the sequence of the variable region of the T cell receptor or flow cytometry (FACS). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With an Objective Clinical Tumor Regression Response | 12 days | |||
| PRIMARY | Number of Participants With Adverse Events | 12 days | Participants | NUMBER | |
| SECONDARY | Number of Participants With In Vivo Survival of Transfused Cells | 12 days | 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 |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events | Metastatic Cancer | 1 | Participants | ||
| Number of Participants With In Vivo Survival of Transfused Cells | Metastatic Cancer | 1 | 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 | Metastatic Cancer | 1 | |
| Overall Study | COMPLETED | Metastatic Cancer | 0 | |
| Overall Study | NOT COMPLETED | Metastatic Cancer | 1 |
Source ClinicalTrials.gov
Adverse events24
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 | Hemoglobin decreased | Blood and lymphatic system disorders | Metastatic Cancer | 1 | 1 | 2 |
| other | Leukocyte count decreased | Blood and lymphatic system disorders | Metastatic Cancer | 1 | 1 | 1 |
| other | Lymphocyte count decreased | Blood and lymphatic system disorders | Metastatic Cancer | 1 | 1 | 1 |
| other | Neutrophil count decreased | Blood and lymphatic system disorders | Metastatic Cancer | 1 | 1 | 1 |
| other | Hypotension | Cardiac disorders | Metastatic Cancer | 1 | 1 | 2 |
| other | Fibrinogen decreased | Blood and lymphatic system disorders | Metastatic Cancer | 1 | 1 | 1 |
| other | Activated partial thromboplastin time prolonged | Metabolism and nutrition disorders | Metastatic Cancer | 1 | 1 | 1 |
| other | Acidosis | Metabolism and nutrition disorders | Metastatic Cancer | 1 | 1 | 1 |
| other | Serum albumin decreased | Metabolism and nutrition disorders | Metastatic Cancer | 1 | 1 | 1 |
| other | Alanine aminotransferase increased | Metabolism and nutrition disorders | Metastatic Cancer | 1 | 1 | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metastatic Cancer | ||
| Total, other adverse events | Metastatic Cancer | 1 | 1 |
| Total, serious adverse events | Metastatic Cancer | 1 | 1 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
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/NCT00924287
GET https://conductscience.org/api/trials/v1/NCT00924287/events?page=2