Trial · NCT02948426
Intraperitoneal Infusion of Autologous Monocytes With Sylatron (Peginterferon Alfa-2b) and Actimmune (Interferon Gamma-1b) in Women With Recurrent or Refractory Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer
NCT02948426, Phase 1, Terminated, National Cancer Institute (NCI); results first posted 2021-06-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Intraperitoneal Infusion of Autologous Monocytes With Sylatron (Peginterferon Alfa-2b) and Actimmune (Interferon Gamma-1b) in Women With Recurrent or Refractory Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer. Trials, record NCT02948426. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02948426
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Intraperitoneal Infusion of Autologous Monocytes With Sylatron (Peginterferon Alfa-2b) and Actimmune (Interferon Gamma-1b) in Women With Recurrent or Refractory Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer
- NCT number
- NCT02948426
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 18 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cancer
- Interventions
- Autologous Monocytes + ACTIMMUNE + SYLATRON
- First posted
- 2016-10-28
- Last updated
- 2026-01-08
- Results first posted
- 2021-06-16
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Maximum Tolerated Dose of Intraperitoneal Autologous Monocytes | Cycle 1 Day 28 | Maximum Tolerated Dose of intraperitoneal autologous monocytes. |
| Primary | Overall Maximum Tolerated Dose of Sylatron (Peginterferon Alpha-2b) | Cycle 1 Day 28 | Maximum Tolerated Dose of Sylatron (Peginterferon alpha-2b). |
| Primary | Overall Maximum Tolerated Dose of Actimmune (Interferon Gamma-1b) | Cycle 1 Day 28 | Maximum Tolerated Dose of Actimmune (Interferon gamma-1b). |
| Secondary | Number of Participants With a Response | Participants were evaluated for response by radiographic imaging every 8 weeks, up to 80 weeks | Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. |
| Secondary | Time to Disease Progression | Participants were assessed every 4 weeks by physical exam and 8 weeks by radiographic imaging for disease progression, up to 10 months. | Time to disease progression is defined as the time from registration to progression, censored at date last known progression-free for those who have not progressed. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study |
| Other | Number of Participants With Serious or Non-serious (Any) Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 10 months and 11 days for dose level 1,12 months and 1 day for dose level 2, 11 months and 4 days for dose level 3, and 12 months and 6 days for dose level 4. | Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). 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 | Number of Participants With a Grade 3 or Higher Dose-Limiting Toxicity (DLT) | Cycle 1 Day 28 | DLT is defined as an laboratory abnormality or adverse drug reaction (ADR) according to the Common Terminology Criteria for Adverse Events (CTCAE), such as any grade 4 immune mediated adverse event attributed to local tumor response, any grade ≥3 colitis, grade 3 or 4 noninfectious pneumonitis, and any \> grade 2 cardiac toxicity which dose not resolve to grade 1 within 3 days of initiation of maximum supportive care that is possibly, probably, or definitely related to the combination of drug. Grade 3 adverse event is severe or medically significant but not immediately life-threatening, Grade 4 is life-threatening, and Grade 5 is death related to adverse event. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Maximum Tolerated Dose of Intraperitoneal Autologous Monocytes | Cycle 1 Day 28 | Cells | NUMBER | |
| PRIMARY | Overall Maximum Tolerated Dose of Sylatron (Peginterferon Alpha-2b) | Cycle 1 Day 28 | mcg | NUMBER | |
| PRIMARY | Overall Maximum Tolerated Dose of Actimmune (Interferon Gamma-1b) | Cycle 1 Day 28 | mcg | NUMBER | |
| SECONDARY | Number of Participants With a Response | Participants were evaluated for response by radiographic imaging every 8 weeks, up to 80 weeks | One participant is not included in the analysis because the participant was not evaluable for response in dose level 1. The participant came off study due to inability to replace her IP catheter (became ineligible) after cycle 1. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Disease Progression | Participants were assessed every 4 weeks by physical exam and 8 weeks by radiographic imaging for disease progression, up to 10 months. | Months | MEDIAN | |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious or Non-serious (Any) Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 10 months and 11 days for dose level 1,12 months and 1 day for dose level 2, 11 months and 4 days for dose level 3, and 12 months and 6 days for dose level 4. | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With a Grade 3 or Higher Dose-Limiting Toxicity (DLT) | Cycle 1 Day 28 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Maximum Tolerated Dose of Intraperitoneal Autologous Monocytes | All Participants On Dose Level 1 Through Dose Level 4 | 750000000 | Cells | ||
| Overall Maximum Tolerated Dose of Sylatron (Peginterferon Alpha-2b) | All Participants On Dose Level 1 Through Dose Level 4 | 250 | mcg | ||
| Overall Maximum Tolerated Dose of Actimmune (Interferon Gamma-1b) | All Participants On Dose Level 1 Through Dose Level 4 | 50 | mcg | ||
| Number of Participants With a Response | Dose Level 1 - Sylatron 25µg (0.1 µg/ml); Actimmune 5mg (0.02µg/ml) | Complete Response | 0 | Participants | |
| Number of Participants With a Response | Dose Level 2 - Monocytes (75x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml) | Complete Response | 0 | Participants | |
| Number of Participants With a Response | Dose Level 3 - Monocytes (750x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml) | Complete Response | 0 | Participants | |
| Number of Participants With a Response | Dose Level 4 - Monocytes (750x10^6); Sylatron 250µg (1µg/ml); Actimmune 50mg (0.2µg/ml) | Complete Response | 0 | Participants | |
| Number of Participants With a Response | Dose Level 1 - Sylatron 25µg (0.1 µg/ml); Actimmune 5mg (0.02µg/ml) | Partial Response | 1 | Participants | |
| Number of Participants With a Response | Dose Level 2 - Monocytes (75x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml) | Partial Response | 0 | Participants | |
| Number of Participants With a Response | Dose Level 3 - Monocytes (750x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml) | Partial Response | 0 | Participants |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Level 1 - Sylatron 25µg (0.1 µg/ml); Actimmune 5mg (0.02µg/ml) | 3 | |
| Overall Study | STARTED | Dose Level 2 - Monocytes (75x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml) | 6 | |
| Overall Study | STARTED | Dose Level 3 - Monocytes (750x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml) | 3 | |
| Overall Study | STARTED | Dose Level 4 - Monocytes (750x10^6); Sylatron 250µg (1µg/ml); Actimmune 50mg (0.2µg/ml) | 6 | |
| Overall Study | COMPLETED | Dose Level 1 - Sylatron 25µg (0.1 µg/ml); Actimmune 5mg (0.02µg/ml) | 3 | |
| Overall Study | COMPLETED | Dose Level 2 - Monocytes (75x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml) | 6 | |
| Overall Study | COMPLETED | Dose Level 3 - Monocytes (750x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml) | 3 | |
| Overall Study | COMPLETED | Dose Level 4 - Monocytes (750x10^6); Sylatron 250µg (1µg/ml); Actimmune 50mg (0.2µg/ml) | 6 | |
| Overall Study | NOT COMPLETED | Dose Level 1 - Sylatron 25µg (0.1 µg/ml); Actimmune 5mg (0.02µg/ml) | 0 | |
| Overall Study | NOT COMPLETED | Dose Level 2 - Monocytes (75x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events420
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 | Abdominal distension | Gastrointestinal disorders | Dose Level 1 - Sylatron 25µg (0.1 µg/ml); Actimmune 5mg (0.02µg/ml) | 1 | 3 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Dose Level 2 - Monocytes (75x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml) | 1 | 6 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Dose Level 3 - Monocytes (750x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml) | 0 | 3 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Dose Level 4 - Monocytes (750x10^6); Sylatron 250µg (1µg/ml); Actimmune 50mg (0.2µg/ml) | 1 | 6 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Dose Level 1 - Sylatron 25µg (0.1 µg/ml); Actimmune 5mg (0.02µg/ml) | 2 | 3 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Dose Level 2 - Monocytes (75x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml) | 1 | 6 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Dose Level 3 - Monocytes (750x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml) | 2 | 3 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Dose Level 4 - Monocytes (750x10^6); Sylatron 250µg (1µg/ml); Actimmune 50mg (0.2µg/ml) | 3 | 6 | 6 |
| other | Activated partial thromboplastin time prolonged | Investigations | Dose Level 1 - Sylatron 25µg (0.1 µg/ml); Actimmune 5mg (0.02µg/ml) | 1 | 3 | 2 |
| other | Activated partial thromboplastin time prolonged | Investigations | Dose Level 2 - Monocytes (75x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml) | 3 | 6 | 3 |
1 to 10 of 420Source ClinicalTrials.gov
See all 420 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 1 - Sylatron 25µg (0.1 µg/ml); Actimmune 5mg (0.02µg/ml) | 1 | 3 |
| Total, all-cause mortality | Dose Level 2 - Monocytes (75x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml) | 2 | 6 |
| Total, all-cause mortality | Dose Level 3 - Monocytes (750x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml) | 0 | 3 |
| Total, all-cause mortality | Dose Level 4 - Monocytes (750x10^6); Sylatron 250µg (1µg/ml); Actimmune 50mg (0.2µg/ml) | 0 | 6 |
| Total, other adverse events | Dose Level 1 - Sylatron 25µg (0.1 µg/ml); Actimmune 5mg (0.02µg/ml) | 3 | 3 |
| Total, other adverse events | Dose Level 2 - Monocytes (75x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml) | 6 | 6 |
| Total, other adverse events | Dose Level 3 - Monocytes (750x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml) | 3 | 3 |
| Total, other adverse events | Dose Level 4 - Monocytes (750x10^6); Sylatron 250µg (1µg/ml); Actimmune 50mg (0.2µg/ml) | 6 | 6 |
| Total, serious adverse events | Dose Level 1 - Sylatron 25µg (0.1 µg/ml); Actimmune 5mg (0.02µg/ml) | 2 | 3 |
| Total, serious adverse events | Dose Level 2 - Monocytes (75x10^6); Sylatron 25µg (0.1µg/ml); Actimmune 5mg (0.02µg/ml) | 6 | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers6
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.
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