Adults 18 to 99, any sex, with Mesothelioma or Adenocarcinoma of Lung. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Response AssessmentPrimary· 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 L
Complete Response
Group
Value
95% CI
Mesothelioma Pilot Phase Regimen A
0
Mesothelioma Pilot Phase Regimen
0
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
0
Phase 2 Pleural Mesothelioma Pilot Expansion Phase
0
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
0
Partial Response
Group
Value
95% CI
Mesothelioma Pilot Phase Regimen A
2
Mesothelioma Pilot Phase Regimen
0
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
0
Phase 2 Pleural Mesothelioma Pilot Expansion Phase
0
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
0
Stable Disease
Group
Value
95% CI
Mesothelioma Pilot Phase Regimen A
5
Mesothelioma Pilot Phase Regimen
6
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
6
Phase 2 Pleural Mesothelioma Pilot Expansion Phase
6
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
1
Progressive Disease
Group
Value
95% CI
Mesothelioma Pilot Phase Regimen A
3
Mesothelioma Pilot Phase Regimen
1
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
1
Phase 2 Pleural Mesothelioma Pilot Expansion Phase
3
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
2
Count of Participants With SS1P Antibody FormationPrimary· 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.
Group
Value
95% CI
Mesothelioma Pilot Phase Regimen A
6
Mesothelioma Pilot Phase Regimen B
2
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
3
Phase 2 Pleural Mesothelioma Pilot Expansion Phase
7
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
0
Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
0
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 CyclophosphamidePrimary· 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 o
Group
Value
95% CI
Mesothelioma Pilot Phase Regimen A
11
Mesothelioma Pilot Phase Regimen B
8
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
7
Phase 2 Pleural Mesothelioma Pilot Expansion Phase
15
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
4
Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
0
Recommended Phase 2 Dose (RP2D) in Drug Lot FIL129J01Primary· 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.
Group
Value
95% CI
Meso., Peritoneal, Pleural & Pancreatic Regimen A
25
Overall SurvivalSecondary· 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).
Group
Value
95% CI
Mesothelioma Pilot Phase Regimen A
8.9
5.4 – 32.2
Mesothelioma Pilot Phase Regimen B
11.2
1.0 – 13.0
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
29.3
3.4 – 29.3
Phase 2 Pleural Mesothelioma Pilot Expansion Phase
4.2
2.0 – 7.9
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
9.3
1.2 – 15.1
Progression-free SurvivalSecondary· 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
Group
Value
95% CI
Meothelioma Pilot Phase Phase Regimen A
11.8
1.6 – 13.6
Meothelioma Pilot Phase Regimen B
8.8
0.6 – 13.0
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
8.9
1.8 – NA
Phase 2 Pleural Mesothelioma Pilot Expansion Phase
3.9
1.6 – 6.4
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
4.4
0.9 – 7.4
Duration of ResponseSecondary· 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-tar
Group
Value
95% CI
Mesothelioma Pilot Phase Regimen A
16.3
10.6 – 26.2
Count of Participants SS1P Cycles Received Following OnstudySecondary· Cycles 1-6, up to 180 days
Here are the number of participants who had SS1P cycles during cycle 1-6.
SS1P 1 Cycle
Group
Value
95% CI
Mesothelioma Pilot Phase Regimen A
1
Mesothelioma Pilot Phase Regimen B
3
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
0
Phase 2 Pleural Mesothelioma Pilot Expansion Phase
5
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
2
Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
0
SS1P 2 Cycles
Group
Value
95% CI
Mesothelioma Pilot Phase Regimen A
8
Mesothelioma Pilot Phase Regimen B
0
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
4
Phase 2 Pleural Mesothelioma Pilot Expansion Phase
8
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
1
Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
0
SS1P 3 Cycles
Group
Value
95% CI
Mesothelioma Pilot Phase Regimen A
0
Mesothelioma Pilot Phase Regimen B
3
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
0
Phase 2 Pleural Mesothelioma Pilot Expansion Phase
1
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
1
Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
0
SS1P 4 Cycles
Group
Value
95% CI
Mesothelioma Pilot Phase Regimen A
1
Mesothelioma Pilot Phase Regimen B
1
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
3
Phase 2 Pleural Mesothelioma Pilot Expansion Phase
0
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
0
Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
0
SS1P 5 Cycles
Group
Value
95% CI
Mesothelioma Pilot Phase Regimen A
0
Mesothelioma Pilot Phase Regimen B
1
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
0
Phase 2 Pleural Mesothelioma Pilot Expansion Phase
1
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
0
Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
0
SS1P 6 Cycles
Group
Value
95% CI
Mesothelioma Pilot Phase Regimen A
1
Mesothelioma Pilot Phase Regimen B
0
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
0
Phase 2 Pleural Mesothelioma Pilot Expansion Phase
0
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
0
Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Date treatment consent signed to date off study, approximately 64 months and 26 days..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Mesothelioma Pilot Phase Regimen A
Serious: 6/11 (55%)
Deaths: 5/11
Mesothelioma Pilot Phase Regimen B
Serious: 8/8 (100%)
Deaths: 8/8
Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
Serious: 3/7 (43%)
Deaths: 3/7
Phase 2 Pleural Mesothelioma Pilot Expansion Phase
Serious: 9/15 (60%)
Deaths: 9/15
Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A
Serious: 1/8 (13%)
Deaths: 1/8
Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
Serious: 1/4 (25%)
Deaths: 1/4
Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
Serious: 0
Deaths: 0
Serious adverse events (9 terms)
Reaction
System
Mesothelioma Pilot Phase R…
Mesothelioma Pilot Phase R…
Phase 2 Peritoneal Mesothe…
Phase 2 Pleural Mesothelio…
Mesothelioma Positive Ca D…
Phase 2 Pancreatic Adenoca…
Phase 2 Lung Adenocarcinom…
Death NOS
General disorders
—
—
—
—
—
—
—
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
—
—
—
Acute kidney injury
Renal and urinary disorders
—
—
—
—
—
—
—
Fever
General disorders
—
—
—
—
—
—
—
Lung infection
Infections and infestations
—
—
—
—
—
—
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
Atrial fibrillation
Cardiac disorders
—
—
—
—
—
—
—
Hypoxia
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
Other adverse events (131 terms — click to expand)
Background:
* Malignant mesothelioma is a form of cancer that develops on the protective lining that covers the body's internal organs. It most often occurs on the lining of the lungs and chest wall or the lining of the abdomen. There is no known cure for malignant mesothelioma, so researchers are searching for new ways to treat it.
* Mesothelin is a protein that is found in mesothelioma and other types of cancer cells. An experimental cancer drug called SS1P is designed to attack cells that have mesothelin while leaving healthy cells alone. Researchers want to test how effective SS1P is when it is given with pentostatin and cyclophosphamide. These drugs help suppress the immune system and may make the SS1P more effective.
Objectives:
\- To study the effectiveness of SS1P plus two drugs that suppress the immune system to treat malignant mesothelioma.
Eligibility:
\- Individuals at least 18 years of age who have malignant mesothelioma in the chest or abdomen.
Design:
* Participants will be screened with a physical exam, medical history, and blood tests. They will also have imaging studies.
* The first treatment cycle will last 30 days. Up to three 21-day cycles of treatment will follow.
* In the first cycle, participants will have pentostatin on days 1, 5, and 9. They will have cyclophosphamide on days 1 through 12. They will have SS1P on days 10, 12, and 14.
* On the next three cycles, participants will have pentostatin on day 1.They will have cyclophosphamide on days 1 through 4. They will have SS1P on days 2, 4, and 6.
* Participants will have frequent blood tests and other studies. They will receive all four cycles of treatment as long as there are no severe side effects.
* Participants will have regular followup visits as directed by the study doctors.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 6 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01362790.