Trial · NCT01585428
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Human Papillomavirus-Associated Cancers
NCT01585428, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-03-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Human Papillomavirus-Associated Cancers. Trials, record NCT01585428. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01585428
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Human Papillomavirus-Associated Cancers
- NCT number
- NCT01585428
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Cervical Cancer, Oropharyngeal Cancer, Vaginal Cancer, Anal Cancer, Penile Cancer
- Interventions
- Fludarabine, Cyclophosphamide, Young TIL, Aldesleukin
- First posted
- 2012-04-25
- Last updated
- 2018-03-07
- Results first posted
- 2017-03-23
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With an Objective Clinical Response | 4 months after cell infusion | Patients must have a partial response (PR) or complete response (CR) at least 4 months after cell infusion to count towards clinical response. Clinical response is assessed by the Response Criteria in Solid Tumors (RECIST) v1.0. 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. Complete response is disappearance of all target lesions. Progression 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 is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD. |
| Secondary | Number of Patients With Serious and Non-serious Adverse Events | 51 months and 18 days | Here is the number of serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). 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. A non-serious adverse event is any untoward medical occurrence. |
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 | Number of Participants With an Objective Clinical Response | 4 months after cell infusion | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients With Serious and Non-serious Adverse Events | 51 months and 18 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
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 an Objective Clinical Response | Cervical | Partial Response | 3 | Participants | |
| Number of Participants With an Objective Clinical Response | NonCervical | Partial Response | 2 | Participants | |
| Number of Participants With an Objective Clinical Response | Cervical | Complete Response | 2 | Participants | |
| Number of Participants With an Objective Clinical Response | NonCervical | Complete Response | 0 | Participants | |
| Number of Participants With an Objective Clinical Response | Cervical | Progressive Disease | 12 | Participants | |
| Number of Participants With an Objective Clinical Response | NonCervical | Progressive Disease | 8 | Participants | |
| Number of Participants With an Objective Clinical Response | Cervical | Stable Disease | 1 | Participants | |
| Number of Participants With an Objective Clinical Response | NonCervical | Stable Disease | 1 | Participants | |
| Number of Patients With Serious and Non-serious Adverse Events | Cervical | 18 | Participants | ||
| Number of Patients With Serious and Non-serious Adverse Events | NonCervical | 11 | 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 | Cervical | 18 | |
| Overall Study | STARTED | NonCervical | 11 | |
| Overall Study | COMPLETED | Cervical | 17 | |
| Overall Study | COMPLETED | NonCervical | 11 | |
| Overall Study | NOT COMPLETED | Cervical | 1 | |
| Overall Study | NOT COMPLETED | NonCervical | 0 |
Source ClinicalTrials.gov
Adverse events124
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 | Cervical | 16 | 18 | 16 |
| other | Hemoglobin | Blood and lymphatic system disorders | NonCervical | 8 | 11 | 8 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Cervical | 10 | 18 | 10 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | NonCervical | 8 | 11 | 8 |
| other | Lymphopenia | Blood and lymphatic system disorders | Cervical | 17 | 18 | 18 |
| other | Lymphopenia | Blood and lymphatic system disorders | NonCervical | 10 | 11 | 10 |
| other | Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | Cervical | 17 | 18 | 17 |
| other | Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | NonCervical | 11 | 11 | 11 |
| other | Platelets | Blood and lymphatic system disorders | Cervical | 17 | 18 | 17 |
| other | Platelets | Blood and lymphatic system disorders | NonCervical | 11 | 11 | 11 |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cervical | 1 | 18 |
| Total, all-cause mortality | NonCervical | 0 | 11 |
| Total, other adverse events | Cervical | 17 | 18 |
| Total, other adverse events | NonCervical | 11 | 11 |
| Total, serious adverse events | Cervical | 4 | 18 |
| Total, serious adverse events | NonCervical | 2 | 11 |
Source ClinicalTrials.gov
Papers5
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cervical vs NonCervical: Number of Patients With Serious and Non-serious Adverse Events | Trial comparisons |
| Cervical vs NonCervical: deaths from any cause | Trial comparisons |
| Cervical vs NonCervical: 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/NCT01585428
GET https://conductscience.org/api/trials/v1/NCT01585428/events?page=2