Trial · NCT00513604
Phase II Study of Short-Term Cultured Anti-Tumor Autologous Lymphocytes After Lymphocyte-Depleting Chemotherapy in Metastatic Melanoma
NCT00513604, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-05-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Study of Short-Term Cultured Anti-Tumor Autologous Lymphocytes After Lymphocyte-Depleting Chemotherapy in Metastatic Melanoma. Trials, record NCT00513604. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00513604
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Short-Term Cultured Anti-Tumor Autologous Lymphocytes After Lymphocyte-Depleting Chemotherapy in Metastatic Melanoma
- NCT number
- NCT00513604
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 158 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Melanoma, Malignant Melanoma, Melanoma, Experimental, Experimental Melanomas
- Interventions
- aldesleukin, therapeutic autologous lymphocytes, Cyclophosphamide, Fludarabine phosphate, Total body irradiation
- First posted
- 2007-08-08
- Last updated
- 2013-06-03
- Results first posted
- 2013-05-27
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 | every 1-3 months until disease progression. Total length of time -8/7/2007 to 9/27/2012 | Clinical response is defined as complete response (CR)- a disappearance of all target lesions, partial response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD)- at least a 20% increase in the sum of the 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) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. |
| Primary | Toxicity | 5 years | Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event 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 | every 1-3 months until disease progression. Total length of time -8/7/2007 to 9/27/2012 | Participants | NUMBER | |
| PRIMARY | Toxicity | 5 years | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Response | Cohort 1 - NMA, TIL, Aldesleukin | Complete Response | 1 | Participants | |
| Clinical Response | Cohort 2 - NMA, CD4+ TIL, Aldesleukin | Complete Response | 3 | Participants | |
| Clinical Response | Cohort 3 - NMA, Total Body Irradiation | Complete Response | 3 | Participants | |
| Clinical Response | Cohort 4 - NMA, Young TIL, Aldesleukin | Complete Response | 2 | Participants | |
| Clinical Response | Cohort 5 - NMA, CD4+TIL, HD Aldesleukin | Complete Response | 3 | Participants | |
| Clinical Response | Cohort 1 - NMA, TIL, Aldesleukin | Partial Response | 3 | Participants | |
| Clinical Response | Cohort 2 - NMA, CD4+ TIL, Aldesleukin | Partial Response | 18 | Participants | |
| Clinical Response | Cohort 3 - NMA, Total Body Irradiation | Partial Response | 7 | Participants | |
| Clinical Response | Cohort 4 - NMA, Young TIL, Aldesleukin | Partial Response | 10 | Participants | |
| Clinical Response | Cohort 5 - NMA, CD4+TIL, HD Aldesleukin | Partial Response | 4 | Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 - NMA, TIL, Aldesleukin | 26 | |
| Overall Study | STARTED | Cohort 2 - NMA, CD4+ TIL, Aldesleukin | 39 | |
| Overall Study | STARTED | Cohort 3 - NMA, Total Body Irradiation | 24 | |
| Overall Study | STARTED | Cohort 4 - NMA, Young TIL, Aldesleukin | 34 | |
| Overall Study | STARTED | Cohort 5 - NMA, CD4+TIL, HD Aldesleukin | 35 | |
| Overall Study | COMPLETED | Cohort 1 - NMA, TIL, Aldesleukin | 24 | |
| Overall Study | COMPLETED | Cohort 2 - NMA, CD4+ TIL, Aldesleukin | 36 | |
| Overall Study | COMPLETED | Cohort 3 - NMA, Total Body Irradiation | 21 | |
| Overall Study | COMPLETED | Cohort 4 - NMA, Young TIL, Aldesleukin | 34 | |
| Overall Study | COMPLETED | Cohort 5 - NMA, CD4+TIL, HD Aldesleukin | 35 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events765
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 | Anemia | Blood and lymphatic system disorders | Cohort 1 - NMA, TIL, Aldesleukin | 15 | 26 | 17 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 2 - NMA, CD4+ TIL, Aldesleukin | 27 | 39 | 32 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 3 - NMA, Total Body Irradiation | 20 | 24 | 23 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 4 - NMA, Young TIL, Aldesleukin | 11 | 34 | 14 |
| other | Anemia | Blood and lymphatic system disorders | Cohort 5 - NMA, CD4+TIL, HD Aldesleukin | 18 | 35 | 21 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cohort 1 - NMA, TIL, Aldesleukin | 10 | 26 | 10 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cohort 2 - NMA, CD4+ TIL, Aldesleukin | 17 | 39 | 17 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cohort 3 - NMA, Total Body Irradiation | 11 | 24 | 11 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cohort 4 - NMA, Young TIL, Aldesleukin | 14 | 34 | 14 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cohort 5 - NMA, CD4+TIL, HD Aldesleukin | 16 | 35 | 16 |
1 to 10 of 765Source ClinicalTrials.gov
See all 765 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 - NMA, TIL, Aldesleukin | ||
| Total, all-cause mortality | Cohort 2 - NMA, CD4+ TIL, Aldesleukin | ||
| Total, all-cause mortality | Cohort 3 - NMA, Total Body Irradiation | ||
| Total, all-cause mortality | Cohort 4 - NMA, Young TIL, Aldesleukin | ||
| Total, all-cause mortality | Cohort 5 - NMA, CD4+TIL, HD Aldesleukin | ||
| Total, other adverse events | Cohort 1 - NMA, TIL, Aldesleukin | 24 | 26 |
| Total, other adverse events | Cohort 2 - NMA, CD4+ TIL, Aldesleukin | 39 | 39 |
| Total, other adverse events | Cohort 3 - NMA, Total Body Irradiation | 23 | 24 |
| Total, other adverse events | Cohort 4 - NMA, Young TIL, Aldesleukin | 34 | 34 |
| Total, other adverse events | Cohort 5 - NMA, CD4+TIL, HD Aldesleukin | 35 | 35 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers5
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/NCT00513604
GET https://conductscience.org/api/trials/v1/NCT00513604/results?page=2