Trial · NCT01814046
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Ocular Melanoma
NCT01814046, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2017-07-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Ocular Melanoma. Trials, record NCT01814046. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01814046
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Ocular Melanoma
- NCT number
- NCT01814046
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Metastatic Ocular Melanoma, Metastatic Uveal Melanoma
- Interventions
- Aldesleukin, Cyclophosphamide, Fludarabine, Young Tumor Infiltrating Lymphocytes (TIL)
- First posted
- 2013-03-19
- Last updated
- 2018-10-11
- Results first posted
- 2017-07-24
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Ocular Melanoma Treated With Young Tumor Infiltrating Lymphocytes (TIL) With or Without High Dose Aldesleukin With an Objective Response Rate of (Complete Response (CR) + Partial Response (PR)) | approximately 3 years | Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. |
| Secondary | Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0) | 46 months and 12 days | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in 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. |
| Other | Count of Participants With Changes in Visual Symptoms | 6 weeks (+/- 2 weeks) | Visual symptoms (e.g., blurred) were evaluated and if changes had occurred from baseline, i.e. in visual acuity, an ophthalmologic consult was performed. |
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 | Percentage of Participants With Ocular Melanoma Treated With Young Tumor Infiltrating Lymphocytes (TIL) With or Without High Dose Aldesleukin With an Objective Response Rate of (Complete Response (CR) + Partial Response (PR)) | approximately 3 years | percentage of participants | NUMBER | |
| SECONDARY | Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0) | 46 months and 12 days | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Count of Participants With Changes in Visual Symptoms | 6 weeks (+/- 2 weeks) | One out of 24 subjects had blurred vision. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Percentage of Participants With Ocular Melanoma Treated With Young Tumor Infiltrating Lymphocytes (TIL) With or Without High Dose Aldesleukin With an Objective Response Rate of (Complete Response (CR) + Partial Response (PR)) | Cells + High Dose Aldesleukin | Complete Response (CR) | 4.54 | 95% Confidence Interval 0 to 22.8 | percentage of participants |
Percentage of Participants With Ocular Melanoma Treated With Young Tumor Infiltrating Lymphocytes (TIL) With or Without High Dose Aldesleukin With an Objective Response Rate of (Complete Response (CR) + Partial Response (PR)) | Cells and no High Dose Aldesleukin | Complete Response (CR) | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
Percentage of Participants With Ocular Melanoma Treated With Young Tumor Infiltrating Lymphocytes (TIL) With or Without High Dose Aldesleukin With an Objective Response Rate of (Complete Response (CR) + Partial Response (PR)) | Cells + High Dose Aldesleukin | Partial Response (PR) | 31.81 | 95% Confidence Interval 13.9 to 54.9 | percentage of participants |
Percentage of Participants With Ocular Melanoma Treated With Young Tumor Infiltrating Lymphocytes (TIL) With or Without High Dose Aldesleukin With an Objective Response Rate of (Complete Response (CR) + Partial Response (PR)) | Cells and no High Dose Aldesleukin | Partial Response (PR) | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0) | Cells + High Dose Aldesleukin | 22 | Participants | ||
| Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0) | Cells and no High Dose Aldesleukin | 2 | Participants | ||
| Count of Participants With Changes in Visual Symptoms | Cells + High Dose Aldesleukin | 1 | Participants | ||
| Count of Participants With Changes in Visual Symptoms | Cells and no High Dose Aldesleukin | 0 | Participants |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Drug Administration | STARTED | Cells + High Dose Aldesleukin | 22 | |
| Drug Administration | STARTED | Cells and no High Dose Aldesleukin | 2 | |
| Drug Administration | STARTED | Cells + High-Dose Aldesleukin Retreatment | 0 | |
| Drug Administration | COMPLETED | Cells + High Dose Aldesleukin | 21 | |
| Drug Administration | COMPLETED | Cells and no High Dose Aldesleukin | 2 | |
| Drug Administration | COMPLETED | Cells + High-Dose Aldesleukin Retreatment | 0 | |
| Drug Administration | NOT COMPLETED | Cells + High Dose Aldesleukin | 1 | |
| Drug Administration | NOT COMPLETED | Cells and no High Dose Aldesleukin | 0 | |
| Drug Administration | NOT COMPLETED | Cells + High-Dose Aldesleukin Retreatment | 0 | |
| Retreatment | STARTED | Cells + High Dose Aldesleukin | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events114
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 | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Cells + High-Dose Aldesleukin | 1 | 22 | 1 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Cells and No High-Dose Aldesleukin | 1 | 2 | 1 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Cells + High-Dose Aldesleukin Retreatment | 0 | 3 | 0 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | Cells + High-Dose Aldesleukin | 3 | 22 | 3 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | Cells and No High-Dose Aldesleukin | 1 | 2 | 1 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | Cells + High-Dose Aldesleukin Retreatment | 0 | 3 | 0 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Cells + High-Dose Aldesleukin | 2 | 22 | 2 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Cells and No High-Dose Aldesleukin | 0 | 2 | 0 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Cells + High-Dose Aldesleukin Retreatment | 0 | 3 | 0 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | Cells + High-Dose Aldesleukin | 2 | 22 | 2 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cells + High-Dose Aldesleukin | 1 | 22 |
| Total, all-cause mortality | Cells and No High-Dose Aldesleukin | 0 | 2 |
| Total, all-cause mortality | Cells + High-Dose Aldesleukin Retreatment | 0 | 3 |
| Total, other adverse events | Cells + High-Dose Aldesleukin | 22 | 22 |
| Total, other adverse events | Cells and No High-Dose Aldesleukin | 2 | 2 |
| Total, other adverse events | Cells + High-Dose Aldesleukin Retreatment | 3 | 3 |
| Total, serious adverse events | Cells + High-Dose Aldesleukin | 1 | 22 |
| Total, serious adverse events | Cells and No High-Dose Aldesleukin | 0 | 2 |
| Total, serious adverse events | Cells + High-Dose Aldesleukin Retreatment | 2 | 3 |
Source ClinicalTrials.gov
Papers4
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cells + High Dose Aldesleukin vs Cells and no High Dose Aldesleukin: Count of Participants With Changes in Visual Symptoms | Trial comparisons |
Cells + High Dose Aldesleukin vs Cells and no High Dose Aldesleukin: Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0) | 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/NCT01814046
GET https://conductscience.org/api/trials/v1/NCT01814046/events?page=2