Trial · NCT00670748
Chemotherapy Followed by ESO-1 Lymphocytes and Aldesleukin to Treat Metastatic Cancer
NCT00670748, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2016-06-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Chemotherapy Followed by ESO-1 Lymphocytes and Aldesleukin to Treat Metastatic Cancer. Trials, record NCT00670748. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00670748
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemotherapy Followed by ESO-1 Lymphocytes and Aldesleukin to Treat Metastatic Cancer
- NCT number
- NCT00670748
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Metastatic Melanoma, Metastatic Renal Cell Cancer, Metastatic Cancer
- Interventions
- Anti-NY ESO-1 T-cell receptor PBL, aldesleukin, Cyclophosphamide, fludarabine phosphate, ALVAC NY ESO-1 vaccine
- First posted
- 2008-05-02
- Last updated
- 2019-11-19
- Results first posted
- 2016-06-27
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) | Approximately 3 years | Response was determined by the 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 started 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 In Vivo Survival of T-Cell Receptor (TCR)-Engineered Cells | 1 month post treatment | Immunological monitoring using both tetramer analysis and staining for the T cell receptor (TCR). This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells. |
| Secondary | Number of Participants With Serious and Non-Serious Adverse Events | Date treatment consent signed to date off study, approximately, 66 months and 10 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. |
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 | Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) | Approximately 3 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With In Vivo Survival of T-Cell Receptor (TCR)-Engineered Cells | 1 month post treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Serious and Non-Serious Adverse Events | Date treatment consent signed to date off study, approximately, 66 months and 10 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) | #1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC | Complete Response | 3 | Participants | |
| Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) | #2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa | Complete Response | 1 | Participants | |
| Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) | #3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC | Complete Response | 1 | Participants | |
| Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) | #4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa | Complete Response | 0 | Participants | |
| Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) | #1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC | Partial Response | 6 | Participants | |
| Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) | #2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa | Partial Response | 7 | Participants | |
| Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) | #3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC | Partial Response | 1 | Participants | |
| Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) | #4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa | Partial Response | 3 | Participants | |
| Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) | #1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC | Progressive Disease | 7 | Participants | |
| Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) | #2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa | Progressive Disease | 7 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | #1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC | 17 | |
| Overall Study | STARTED | #2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa | 16 | |
| Overall Study | STARTED | #3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC | 7 | |
| Overall Study | STARTED | #4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa | 5 | |
| Overall Study | COMPLETED | #1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC | 14 | |
| Overall Study | COMPLETED | #2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa | 14 | |
| Overall Study | COMPLETED | #3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC | 5 | |
| Overall Study | COMPLETED | #4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa | 4 | |
| Overall Study | NOT COMPLETED | #1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC | 3 | |
| Overall Study | NOT COMPLETED | #2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events204
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 | #1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC | 15 | 17 | 15 |
| other | Hemoglobin | Blood and lymphatic system disorders | #2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa | 14 | 16 | 14 |
| other | Hemoglobin | Blood and lymphatic system disorders | #3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC | 4 | 7 | 4 |
| other | Hemoglobin | Blood and lymphatic system disorders | #4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa | 4 | 5 | 4 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | #1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC | 17 | 17 | 17 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | #2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa | 16 | 16 | 16 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | #3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC | 7 | 7 | 7 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | #4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa | 5 | 5 | 5 |
| other | Lymphopenia | Blood and lymphatic system disorders | #1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC | 17 | 17 | 17 |
| other | Lymphopenia | Blood and lymphatic system disorders | #2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa | 16 | 16 | 16 |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | #1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC | 0 | 17 |
| Total, all-cause mortality | #2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa | 0 | 16 |
| Total, all-cause mortality | #3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC | 1 | 7 |
| Total, all-cause mortality | #4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa | 0 | 5 |
| Total, other adverse events | #1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC | 17 | 17 |
| Total, other adverse events | #2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa | 16 | 16 |
| Total, other adverse events | #3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC | 7 | 7 |
| Total, other adverse events | #4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa | 5 | 5 |
| Total, serious adverse events | #1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC | 1 | 17 |
| Total, serious adverse events | #2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa | 3 | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
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/NCT00670748
GET https://conductscience.org/api/trials/v1/NCT00670748/results?page=2