Trial · NCT00704938
Gene-Modified Lymphocytes, High-Dose Aldesleukin, and Vaccine Therapy in Treating Patients With Progressive or Recurrent Metastatic Cancer
NCT00704938, Phase 2, Terminated, National Institutes of Health Clinical Center (CC); results first posted 2012-08-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gene-Modified Lymphocytes, High-Dose Aldesleukin, and Vaccine Therapy in Treating Patients With Progressive or Recurrent Metastatic Cancer. Trials, record NCT00704938. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00704938
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gene-Modified Lymphocytes, High-Dose Aldesleukin, and Vaccine Therapy in Treating Patients With Progressive or Recurrent Metastatic Cancer
- NCT number
- NCT00704938
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Conditions
- Kidney Cancer, Melanoma (Skin), Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- aldesleukin, anti-p53 T-cell receptor-transduced peripheral blood lymphocytes, autologous dendritic cell-adenovirus p53 vaccine, filgrastim, cyclophosphamide, fludarabine phosphate
- First posted
- 2008-06-25
- Last updated
- 2015-10-28
- Results first posted
- 2012-08-14
- Limitations and caveats
- This study was terminated prior to completing accrual due to the withdrawal of support from our collaborator.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Response (Complete Response + Partial Response) | 5 months | Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all lesions. Partial response is a 30% decrease in the sum of the longest diameter (LD) of target lesions. |
| Secondary | Number of Participants With Adverse Events | 5 months | Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse events module. |
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 | Clinical Response (Complete Response + Partial Response) | 5 months | Participants | NUMBER | |
| SECONDARY | Number of Participants With Adverse Events | 5 months | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Response (Complete Response + Partial Response) | Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC | Complete Response | 0 | Participants | |
| Clinical Response (Complete Response + Partial Response) | Anti-p53 TCR PBL + DC + IL-2: Other Histology | Complete Response | 0 | Participants | |
| Clinical Response (Complete Response + Partial Response) | Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC | Partial Response | 0 | Participants | |
| Clinical Response (Complete Response + Partial Response) | Anti-p53 TCR PBL + DC + IL-2: Other Histology | Partial Response | 0 | Participants | |
| Number of Participants With Adverse Events | Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC | 2 | Participants | ||
| Number of Participants With Adverse Events | Anti-p53 TCR PBL + DC + IL-2: Other Histology | 1 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC | 2 | |
| Overall Study | STARTED | Anti-p53 TCR PBL + DC + IL-2: Other Histology | 1 | |
| Overall Study | COMPLETED | Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC | 2 | |
| Overall Study | COMPLETED | Anti-p53 TCR PBL + DC + IL-2: Other Histology | 1 | |
| Overall Study | NOT COMPLETED | Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC | 0 | |
| Overall Study | NOT COMPLETED | Anti-p53 TCR PBL + DC + IL-2: Other Histology | 0 |
Source ClinicalTrials.gov
Adverse events30
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 | Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC | 2 | 2 | 3 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Anti-p53 TCR PBL + DC + IL-2: Other Histology | 1 | 1 | 1 |
| other | Leukocyte count decreased | Blood and lymphatic system disorders | Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC | 2 | 2 | 2 |
| other | Leukocyte count decreased | Blood and lymphatic system disorders | Anti-p53 TCR PBL + DC + IL-2: Other Histology | 1 | 1 | 1 |
| other | lymphocyte count decreased | Blood and lymphatic system disorders | Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC | 2 | 2 | 2 |
| other | lymphocyte count decreased | Blood and lymphatic system disorders | Anti-p53 TCR PBL + DC + IL-2: Other Histology | 1 | 1 | 1 |
| other | Neutrophil count decreased | Blood and lymphatic system disorders | Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC | 2 | 2 | 2 |
| other | Neutrophil count decreased | Blood and lymphatic system disorders | Anti-p53 TCR PBL + DC + IL-2: Other Histology | 1 | 1 | 1 |
| other | Platelet count decreased | Blood and lymphatic system disorders | Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC | 2 | 2 | 2 |
| other | Platelet count decreased | Blood and lymphatic system disorders | Anti-p53 TCR PBL + DC + IL-2: Other Histology | 1 | 1 | 1 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC | ||
| Total, all-cause mortality | Anti-p53 TCR PBL + DC + IL-2: Other Histology | ||
| Total, other adverse events | Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC | 2 | 2 |
| Total, other adverse events | Anti-p53 TCR PBL + DC + IL-2: Other Histology | 1 | 1 |
| Total, serious adverse events | Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC | 0 | 2 |
| Total, serious adverse events | Anti-p53 TCR PBL + DC + IL-2: Other Histology | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC vs Anti-p53 TCR PBL + DC + IL-2: Other Histology: Number of Participants With Adverse Events | Trial comparisons |
| Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC vs Anti-p53 TCR PBL + DC + IL-2: Other Histology: serious adverse events | Trial comparisons |
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/NCT00704938
GET https://conductscience.org/api/trials/v1/NCT00704938/events?page=2