Trial · NCT01362790
SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma
NCT01362790, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2019-06-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma. Trials, record NCT01362790. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01362790
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma
- NCT number
- NCT01362790
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 55 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Mesothelioma, Adenocarcinoma of Lung, Pancreatic Neoplasms
- Interventions
- Pentostatin, Cyclophosphamide, SS1(dsFv)PE38 - lot 073I0809, SS1(dsFv)PE38 - lot FIL129J01
- First posted
- 2011-05-30
- Last updated
- 2019-06-06
- Results first posted
- 2019-06-06
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Assessment | 52 months and 4 days | Response was assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is complete disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease (PD) disease is at least a 20% increase in the sum of the LD of target lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. |
| Primary | Count of Participants With SS1P Antibody Formation | On last day of last dosing cycle, end of cycle 1 (day 30) | Development of antibodies following treatment with SS1P. The goal was to delay development of antibodies to SS1P so a patient could get a second cycle of therapy with SS1P. |
| Primary | Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) Who Were Administered SS1P and Pentostatin or Cyclophosphamide | Date treatment consent signed to date off study, approximately 64 months and 26 days | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in 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. |
| Primary | Recommended Phase 2 Dose (RP2D) in Drug Lot FIL129J01 | Days 1, 3, and 5 of a 21 day cycle | Should any 2 patients within the first 3 to 6 patients experience treatment limiting toxicity requiring cessation of treatment prior to the conclusion of the first cycle, the maximum tolerated dose will have been exceeded and patients will be enrolled to the next lower dose. |
| Secondary | Overall Survival | 36 months | The Kaplan-Meier was used to determine the probability of overall survival from on-study date until death or last follow-up (calculated from the date of study entry until the date of analysis). |
| Secondary | Progression-free Survival | 36 months | Defined as the time interval from the start of treatment to documented evidence of disease progression. Progressive disease is assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria, and is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum on study LD (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Secondary | Duration of Response | up to 2.5 years | DOR is assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria and is measured from the time measurement criteria is met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to\<10mm. 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. Progressive disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum on study LD (this includes the baseline sum if that is the smallest on study). |
| Other | Count of Participants SS1P Cycles Received Following Onstudy | Cycles 1-6, up to 180 days | Here are the number of participants who had SS1P cycles during cycle 1-6. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Assessment | 52 months and 4 days | No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Count of Participants With SS1P Antibody Formation | On last day of last dosing cycle, end of cycle 1 (day 30) | No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) Who Were Administered SS1P and Pentostatin or Cyclophosphamide | Date treatment consent signed to date off study, approximately 64 months and 26 days | No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Recommended Phase 2 Dose (RP2D) in Drug Lot FIL129J01 | Days 1, 3, and 5 of a 21 day cycle | mcg/kg/dose | NUMBER | |
| SECONDARY | Overall Survival | 36 months | No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group. | Months | MEDIAN |
| SECONDARY | Progression-free Survival | 36 months | No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group. | Months | MEDIAN |
| SECONDARY | Duration of Response | up to 2.5 years | In months; the only 3 responders were in group one, thus arm/groups 2-7 are not shown here. | Months | MEDIAN |
| OTHER_PRE_SPECIFIED | Count of Participants SS1P Cycles Received Following Onstudy | Cycles 1-6, up to 180 days | No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Assessment | Mesothelioma Pilot Phase Regimen A | Complete Response | 0 | Participants | |
| Response Assessment | Mesothelioma Pilot Phase Regimen | Complete Response | 0 | Participants | |
| Response Assessment | Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase | Complete Response | 0 | Participants | |
| Response Assessment | Phase 2 Pleural Mesothelioma Pilot Expansion Phase | Complete Response | 0 | Participants | |
| Response Assessment | Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A | Complete Response | 0 | Participants | |
| Response Assessment | Mesothelioma Pilot Phase Regimen A | Partial Response | 2 | Participants | |
| Response Assessment | Mesothelioma Pilot Phase Regimen | Partial Response | 0 | Participants | |
| Response Assessment | Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase | Partial Response | 0 | Participants | |
| Response Assessment | Phase 2 Pleural Mesothelioma Pilot Expansion Phase | Partial Response | 0 | Participants | |
| Response Assessment | Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A | Partial Response | 0 | Participants |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pilot Phase & Phase 2 | STARTED | Mesothelioma Pilot Phase Regimen A | 11 | |
| Pilot Phase & Phase 2 | STARTED | Mesothelioma Pilot Phase Regimen B | 8 | |
| Pilot Phase & Phase 2 | STARTED | Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase | 7 | |
| Pilot Phase & Phase 2 | STARTED | Phase 2 Pleural Mesothelioma Pilot Expansion Phase | 15 | |
| Pilot Phase & Phase 2 | STARTED | Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A | 0 | |
| Pilot Phase & Phase 2 | STARTED | Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A | 4 | |
| Pilot Phase & Phase 2 | STARTED | Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A | 0 | |
| Pilot Phase & Phase 2 | COMPLETED | Mesothelioma Pilot Phase Regimen A | 1 | |
| Pilot Phase & Phase 2 | COMPLETED | Mesothelioma Pilot Phase Regimen B | 0 | |
| Pilot Phase & Phase 2 | COMPLETED | Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase | 2 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events980
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 | Activated partial thromboplastin time prolonged | Investigations | Mesothelioma Pilot Phase Regimen A | 2 | 11 | 2 |
| other | Activated partial thromboplastin time prolonged | Investigations | Mesothelioma Pilot Phase Regimen B | 5 | 8 | 10 |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase | 1 | 7 | 2 |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase 2 Pleural Mesothelioma Pilot Expansion Phase | 7 | 15 | 10 |
| other | Activated partial thromboplastin time prolonged | Investigations | Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A | 3 | 8 | 6 |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A | 2 | 4 | 5 |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A | 0 | 0 | 0 |
| other | Acute kidney injury | Renal and urinary disorders | Mesothelioma Pilot Phase Regimen A | 0 | 11 | 0 |
| other | Acute kidney injury | Renal and urinary disorders | Mesothelioma Pilot Phase Regimen B | 0 | 8 | 0 |
| other | Acute kidney injury | Renal and urinary disorders | Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase | 1 | 7 | 4 |
1 to 10 of 980Source ClinicalTrials.gov
See all 980 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mesothelioma Pilot Phase Regimen A | 5 | 11 |
| Total, all-cause mortality | Mesothelioma Pilot Phase Regimen B | 8 | 8 |
| Total, all-cause mortality | Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase | 3 | 7 |
| Total, all-cause mortality | Phase 2 Pleural Mesothelioma Pilot Expansion Phase | 9 | 15 |
| Total, all-cause mortality | Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A | 1 | 8 |
| Total, all-cause mortality | Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A | 1 | 4 |
| Total, all-cause mortality | Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A | 0 | 0 |
| Total, other adverse events | Mesothelioma Pilot Phase Regimen A | 11 | 11 |
| Total, other adverse events | Mesothelioma Pilot Phase Regimen B | 8 | 8 |
| Total, other adverse events | Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase | 7 | 7 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers3
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
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