Trial · NCT01218867
CAR T Cell Receptor Immunotherapy Targeting VEGFR2 for Patients With Metastatic Cancer
NCT01218867, Phase 1, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2016-07-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. CAR T Cell Receptor Immunotherapy Targeting VEGFR2 for Patients With Metastatic Cancer. Trials, record NCT01218867. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01218867
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CAR T Cell Receptor Immunotherapy Targeting VEGFR2 for Patients With Metastatic Cancer
- NCT number
- NCT01218867
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Metastatic Cancer, Metastatic Melanoma, Renal Cancer
- Interventions
- Anti-VEGFR2 CAR CD8 plus PBL, Cyclophosphamide, Aldesleukin, Fludarabine
- First posted
- 2010-10-11
- Last updated
- 2019-12-10
- Results first posted
- 2016-07-22
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 a Response to Therapy | 5 years | Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment starts or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. |
| Secondary | Number of Participants With Serious and Non-Serious Adverse Events | Date treatment consent signed to date off study, approximately, 33 months and 25 days | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Secondary | In Vivo Survival of Chimeric T Cell Receptor (CAR) Gene-engineered Cells | 6 years | Immunological monitoring using both tetramer analysis and staining for the T cell receptor (TCR) will be used to augment polymerase chain reaction (PCR)-based analysis. This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells. |
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 a Response to Therapy | 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Serious and Non-Serious Adverse Events | Date treatment consent signed to date off study, approximately, 33 months and 25 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | In Vivo Survival of Chimeric T Cell Receptor (CAR) Gene-engineered Cells | 6 years | This outcome measure was not done due to the lack of a minimum number (e.g. 4) of required durable responses in the participants. A durable response is defined as a complete response, partial response, or stable disease in at least 4 participants. |
Source ClinicalTrials.gov
Results by group55
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 a Response to Therapy | Cohort 1 - 1x10(6) Cells (High Dose IL-2) | Complete Response (CR) | 0 | Participants | |
| Number of Participants With a Response to Therapy | Cohort 2 - 3x10(6) Cells (High Dose IL-2) | Complete Response (CR) | 0 | Participants | |
| Number of Participants With a Response to Therapy | Cohort 3 - 1x10(7) Cells (High Dose IL-2) | Complete Response (CR) | 0 | Participants | |
| Number of Participants With a Response to Therapy | Cohort 4 - 3x10(7) Cells (High Dose IL-2) | Complete Response (CR) | 0 | Participants | |
| Number of Participants With a Response to Therapy | Cohort 5 - 1x10(8) Cells (High Dose IL-2) | Complete Response (CR) | 0 | Participants | |
| Number of Participants With a Response to Therapy | Cohort 6 - 3x10(8) Cells (High Dose IL-2) | Complete Response (CR) | 0 | Participants | |
| Number of Participants With a Response to Therapy | Cohort 7 - 1x10(9) Cells (High Dose IL-2) | Complete Response (CR) | 0 | Participants | |
| Number of Participants With a Response to Therapy | Cohort 8 - 1x10(9) Cells (Low Dose IL-2) | Complete Response (CR) | 0 | Participants | |
| Number of Participants With a Response to Therapy | Cohort 9 - 3x10(9) Cells (Low Dose IL-2) | Complete Response (CR) | 0 | Participants | |
| Number of Participants With a Response to Therapy | Cohort 10 - 1x10(10) Cells (Low Dose IL-2) | Complete Response (CR) | 0 | Participants |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 results by groupParticipant flow33
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 - 1 x 10(6) Cells (High Dose IL-2) | 1 | |
| Overall Study | STARTED | Cohort 2 - 3 x 10(6) Cells (High Dose IL-2) | 1 | |
| Overall Study | STARTED | Cohort 3 - 1 x 10(7) Cells (High Dose IL-2) | 3 | |
| Overall Study | STARTED | Cohort 4 - 3 x 10(7) Cells (High Dose IL-2) | 1 | |
| Overall Study | STARTED | Cohort 5 - 1 x 10(8) Cells (High Dose IL-2) | 1 | |
| Overall Study | STARTED | Cohort 6 - 3 x 10(8) Cells (High Dose IL-2) | 1 | |
| Overall Study | STARTED | Cohort 7 - 1 x 10(9) Cells (High Dose IL-2) | 4 | |
| Overall Study | STARTED | Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2) | 3 | |
| Overall Study | STARTED | Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2) | 3 | |
| Overall Study | STARTED | Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2) | 4 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 participant flowAdverse events572
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 | Blood and lymphatic system disorders | Cohort 1 (1x10(6) Cells (High Dose IL-2) | 1 | 1 | 1 |
| other | Hemoglobin | Blood and lymphatic system disorders | Cohort 2 (3x10(6) Cells (High Dose IL-2) | 1 | 1 | 1 |
| other | Hemoglobin | Blood and lymphatic system disorders | Cohort 3 (1x10(7) Cells (High Dose IL-2) | 1 | 3 | 1 |
| other | Hemoglobin | Blood and lymphatic system disorders | Cohort 4 (3x10(7) Cells (High Dose IL-2) | 0 | 1 | 0 |
| other | Hemoglobin | Blood and lymphatic system disorders | Cohort 5 (1x10(8) Cells (High Dose IL-2) | 1 | 1 | 1 |
| other | Hemoglobin | Blood and lymphatic system disorders | Cohort 6 (1x10(8) Cells (High Dose IL-2) | 1 | 1 | 1 |
| other | Hemoglobin | Blood and lymphatic system disorders | Cohort 7 (1x10(9) Cells (High Dose IL-2) | 3 | 4 | 3 |
| other | Hemoglobin | Blood and lymphatic system disorders | Cohort 8 (1x10(9) Cells (Low Dose IL-2) | 2 | 3 | 2 |
| other | Hemoglobin | Blood and lymphatic system disorders | Cohort 9 (3x10(9) Cells (Low Dose IL-2) | 1 | 3 | 1 |
| other | Hemoglobin | Blood and lymphatic system disorders | Cohort 10 (1x10(10) Cells (Low Dose IL-2) | 1 | 4 | 1 |
1 to 10 of 572Source ClinicalTrials.gov
See all 572 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 (1x10(6) Cells (High Dose IL-2) | 0 | 1 |
| Total, all-cause mortality | Cohort 2 (3x10(6) Cells (High Dose IL-2) | 0 | 1 |
| Total, all-cause mortality | Cohort 3 (1x10(7) Cells (High Dose IL-2) | 0 | 3 |
| Total, all-cause mortality | Cohort 4 (3x10(7) Cells (High Dose IL-2) | 0 | 1 |
| Total, all-cause mortality | Cohort 5 (1x10(8) Cells (High Dose IL-2) | 0 | 1 |
| Total, all-cause mortality | Cohort 6 (1x10(8) Cells (High Dose IL-2) | 0 | 1 |
| Total, all-cause mortality | Cohort 7 (1x10(9) Cells (High Dose IL-2) | 1 | 4 |
| Total, all-cause mortality | Cohort 8 (1x10(9) Cells (Low Dose IL-2) | 0 | 3 |
| Total, all-cause mortality | Cohort 9 (3x10(9) Cells (Low Dose IL-2) | 0 | 3 |
| Total, all-cause mortality | Cohort 10 (1x10(10) Cells (Low Dose IL-2) | 0 | 4 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers3
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/NCT01218867
GET https://conductscience.org/api/trials/v1/NCT01218867/results?page=2