MesotheliomaPhase 1NCT01445392
SS1(dsFV)PE38 Plus Pemetrexed and Cisplatin to Treat Malignant Pleural Mesothelioma
A Phase 1 study testing Multicycle SS1P, Pemetrexed and Cisplatin in people with Mesothelioma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Standard therapy for mesothelioma is a combination of the drugs pemetrexed and cisplatin. However, the benefits of this treatment are limited, and in most treated patients the disease continues to worsen. SS1(dsFV)PE38 is a genetically engineered drug. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Mesothelioma
- What is being tested?
- Multicycle SS1P, Pemetrexed and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2007to 3 Oct 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be eligible to participate in the study:
- Subjects must have histologically confirmed epithelial or biphasic pleural mesothelioma not amenable to potentially curative surgical resection. However, patients with biphasic tumors that have a predominantly sarcomatoid component will be excluded.
- Measurable disease
- Subjects must be greater than or equal to 18 years old
- Karnofsky Performance Status (KPS) of greater than or equal to 70
- Life expectancy of greater than 3 months, as assessed by the principal investigator.
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- Adequate organ function with:Hepatic function: serum transaminases (either ALT or AST) or bilirubin, less than or equal to Grade 1, unless due to cancer or Gilbert s disease; less than or equal to Grade 2, if due to cancer
- Renal function: serum creatinine clearance greater than or equal to 60mL/min as estimated by Cockroft-Gault formula.
- Bone marrow function: ANC of at least 1,500/mm (3), Platelet count at least 100,000/mm (3)
- Pulmonary Function: FEV (1) greater than or equal to 50 percent of predicted value (post-pleural drainage and bronchodilation if these are indicated)
- Must be able to understand and sign informed consent
- Female and male subjects agree to use an approved method of contraception during the study
Who cannot join
- Subjects must not be pregnant or breast feeding
- Prior radiotherapy (except palliative extra-thoracic localized radiotherapy) or biologic therapy for malignant pleural mesothelioma within 4 weeks
- Prior systemic chemotherapy for malignant pleural mesothelioma
- Documented and ongoing central nervous system involvement with their malignant disease (history of CNS involvement is not an exclusion criterion but the CNS metastases should have been adequately treated (radiation or surgical resection) and subjects are free from symptoms for 3 months off steroids).
- Clinically significant heart disease (New York Heart Association Class III or IV)
- Active bacterial or fungal infection.
Show all 12Show fewer
- Baseline coagulopathy greater than or equal to Grade 3 unless due to anticoagulant therapy
- Surgery or pleurodesis within 2 weeks
- HIV positive serology (due to increased risk of severe infection and unknown interaction of SS1(dsFv)PE38 with antiretroviral drugs)
- Hepatitis B surface antigen positivity
- Subjects with other (non-mesothelioma) cancers who meet eligibility criteria and have had less than 5 years of disease-free survival will be considered on a case-by-case basis
- Uncontrolled, symptomatic, intercurrent illness including but not limited to: infections requiring systemic antibiotics, unstable angina pectoris, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Phase 1, Single Center, Dose-Escalation Study of SS1(dsFv)PE38 Administered Concurrently With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Epithelial Pleural Mesothelioma
Background:
Standard therapy for mesothelioma is a combination of the drugs pemetrexed and cisplatin. However, the benefits of this treatment are limited, and in most treated patients the disease continues to worsen.
Read more
SS1(dsFV)PE38 is a genetically engineered drug. It contains an antibody that binds to a certain protein on mesothelioma cells and a toxin (type of poison) made from a product of a bacterium called Pseudomonas aeruginosa. It is hoped that the antibody will attach to the cancer cells, allowing the toxin to enter and kill the cells.
Objectives:
To find out if SS1(dsFV)PE38, together with pemetrexed and cisplatin is safe and tolerable in patients with mesothelioma.
To determine the maximum tolerated dose of SS1(dsFV)PE38 (the highest dose that does not cause unacceptable side effects).
To see if SS1(dsFV)PE38 given with pemetrexed and cisplatin has any effect on patients tumors.
To learn how the body breaks down SS1(dsFV)PE38.
Eligibility:
Patients 18 years of age and older with epithelial pleural mesothelioma whose disease cannot be cured with surgery, and have not had prior treatment with chemotherapy.
Design:
Treatment with pemetrexed, cisplatin and SS1(dsFV)PE38 in two 21-day cycles as follows:
- Day 1 - Intravenous (through a vein) infusions of pemetrexed and cisplatin.
- Days 1 and 2 - Intravenous solution to prevent dehydration that might occur with SS1(dsFV)PE38.
- Days 1, 3 and 5 Intravenous infusion of SS1(dsFV)PE38. Small groups (3 to 6) of patients are given SS1(dsFV)PE38 at a certain dose level. If the first group experiences no significant side effects, the next group a higher dose. This continues in succeeding groups until the maximum tolerated study dose (highest dose that patients can be given safely) is determined.
Continuing standard treatment with additional cycles of pemetrexed and cisplatin.
Evaluations during the treatment period:
- Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant.
- Questions about medications and side effects.
- Blood and urine tests.
- Disease evaluation with CT, chest X-ray, and possibly PET scans, lung function tests, pulse oximetry, performance of daily activities and quality-of-life questionnaires.
Post-treatment evaluations:
- Clinic visits at months 1, 3, 6, 12, 15, 18 and 21 for physical examination and disease assessment.
- End-of-study visit for blood tests, vital signs and weight measurements, disease assessment, electrocardiogram, pregnancy test for women who can become pregnant
Read the detailed description
Background:
SS1P (dsFv) PE38, is a recombinant immunotoxin targeting the tumor antigen mesothelin that is highly expressed in malignant mesothelioma. The maximum tolerated dose (MTD) of SS1 dsFv has been established in a phase I study.
Combination therapy with pemetrexed plus cisplatin is the standard first line therapy for malignant mesothelioma, but results in a median overall survival of only 12.1 months.
Combination of SS1(dsFv)PE38 with pemetrexed plus cisplatin could result in improved outcomes for patients with mesothelioma.
Objectives:
To determine the MTD of SS1(dsFv)PE38 that can be safely administered in combination with pemetrexed plus cisplatin in patients with mesothelioma.
To characterize the toxicity profile of SS1(dsFv)PE38.
To study the pharmacokinetics of SS1(dsFv)PE388.
To observe anti-tumor activity, if any of SS1(dsFv)PE38 in combination with pemetrexed plus cisplatin.
Eligibility:
Subjects with histologically confirmed epithelial pleural mesothelioma.
No prior radiotherapy (except palliative localized radiotherapy),systemic chemotherapy or biologic therapy for pleural mesothelioma.
Design:
This is a phase I dose-escalation study of SS1(dsFv)PE38 in combination with pemetrexed plus cisplatin.
The dose of pemetrexed plus cisplatin will be the standard dose approved for malignant mesothelioma. The dose of SS1(dsFv)PE38 will be escalated to find the safe dose in combination with pemetrexed plus cisplatin.
SS1(dsFv)PE38 will be administered concurrently with pemetrexed plus cisplatin in cycles one and two, and subjects will receive additional cycles of pemetrexed and cisplatin as per standard practice.
Patients will be assessed for response every 6 weeks.
An additional Single Cycle of SS1(dsFv)PE38 Cohort will involve up to 16 patients who will receive SS1(dsFv)PE38 administered for four or five doses during the first cycle concurrently with pemetrexed and cisplatin; subjects in this cohort will receive additional
cycles of pemetrexed and cisplatin as per standard practice
- Conditions
- Mesothelioma
- Being tested
- Multicycle SS1P, Pemetrexed, Cisplatin, Single cycle SS1P
- Keywords
- Recombinant Immunotoxin, Monoclonal Antibody, Pseudomonas Exotoxin, Targeted Therapy, Pleural Mesothelioma, Mesothelioma, Epithelial Pleural Mesothelioma
- Medical subject headings
- Mesothelioma, Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicycle SS1PBiological
Assigned dose level of SS1(dsFv)PE38 on days 1, 3 \& 5 of a 21 day cycle for 2 cycles
PemetrexedDrug
500 mg/m^2 on day 1 of each 21 day cycle until disease progression
CisplatinDrug
75 mg/m^2 on day 1 of each 21 day cycle until disease progression
Single cycle SS1PBiological
Patients 1 - 3 of single cycle cohort. 45 mcg/kg of SS1(dsFv)PE38 on 4 or 5 days (depending on dose level) of cycle 1 only.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Multi-cycle cohort Receives: Biological: Multicycle SS1P; Drug: Pemetrexed; Drug: Cisplatin |
| 2 | Experimental | Single cycle cohort Receives: Drug: Pemetrexed; Drug: Cisplatin; Biological: Single cycle SS1P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and MTD
list of adverse events and highest dose at which fewer than 2 subjects experienced DLT
Measured: 30 days after last dose
Best overall response
proportion of subjects experiencing complete response, partial response or stable disease as a best overall response
Measured: Assessed every 42 days until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study start14 Nov 2007
- Primary completion31 Jan 2014
- Study completion3 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MesotheliomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Raffit Hassan, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445392
- Sponsor's protocol ID
- 080026
- Other IDs
- 08-C-0026
- Status last verified
- 1 Aug 2018
- First submitted
- 30 Sep 2011
- Last updated
- 3 Aug 2018
- Results posted
- No
- FDA-regulated drug
- Yes
Publications
Chang K, Pastan I. Molecular cloning of mesothelin, a differentiation antigen present on mesothelium, mesotheliomas, and ovarian cancers. Proc Natl Acad Sci U S A. 1996 Jan 9;93(1):136-40. doi: 10.1073/pnas.93.1.136.
PubMed 8552591Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.
PubMed 1244564Hassan R, Kreitman RJ, Pastan I, Willingham MC. Localization of mesothelin in epithelial ovarian cancer. Appl Immunohistochem Mol Morphol. 2005 Sep;13(3):243-7. doi: 10.1097/01.pai.00000141545.36485.d6.
PubMed 16082249
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Center, Dose-Escalation Study of SS1(dsFv)PE38 Administered Concurrently With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Epithelial Pleural Mesothelioma
- ClinicalTrials.gov ID
- NCT01445392
- Acronym / sponsor ID
- 080026
- Conditions
- Mesothelioma
- Keywords
- Recombinant Immunotoxin, Monoclonal Antibody, Pseudomonas Exotoxin, Targeted Therapy, Pleural Mesothelioma, Mesothelioma, Epithelial Pleural Mesothelioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 14 Nov 2007
- Primary completion
- 31 Jan 2014 (actual)
- Study completion
- 3 Oct 2016 (actual)
- First posted
- 3 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Standard therapy for mesothelioma is a combination of the drugs pemetrexed and cisplatin. However, the benefits of this treatment are limited, and in most treated patients the disease continues to worsen.
SS1(dsFV)PE38 is a genetically engineered drug. It contains an antibody that binds to a certain protein on mesothelioma cells and a toxin (type of poison) made from a product of a bacterium called Pseudomonas aeruginosa. It is hoped that the antibody will attach to the cancer cells, allowing the toxin to enter and kill the cells.
Objectives:
To find out if SS1(dsFV)PE38, together with pemetrexed and cisplatin is safe and tolerable in patients with mesothelioma.
To determine the maximum tolerated dose of SS1(dsFV)PE38 (the highest dose that does not cause unacceptable side effects).
To see if SS1(dsFV)PE38 given with pemetrexed and cisplatin has any effect on patients tumors.
To learn how the body breaks down SS1(dsFV)PE38.
Eligibility:
Patients 18 years of age and older with epithelial pleural mesothelioma whose disease cannot be cured with surgery, and have not had prior treatment with chemotherapy.
Design:
Treatment with pemetrexed, cisplatin and SS1(dsFV)PE38 in two 21-day cycles as follows:
- Day 1 - Intravenous (through a vein) infusions of pemetrexed and cisplatin.
- Days 1 and 2 - Intravenous solution to prevent dehydration that might occur with SS1(dsFV)PE38.
- Days 1, 3 and 5 Intravenous infusion of SS1(dsFV)PE38. Small groups (3 to 6) of patients are given SS1(dsFV)PE38 at a certain dose level. If the first group experiences no significant side effects, the next group a higher dose. This continues in succeeding groups until the maximum tolerated study dose (highest dose that patients can be given safely) is determined.
Continuing standard treatment with additional cycles of pemetrexed and cisplatin.
Evaluations during the treatment period:
- Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant.
- Questions about medications and side effects.
- Blood and urine tests.
- Disease evaluation with CT, chest X-ray, and possibly PET scans, lung function tests, pulse oximetry, performance of daily activities and quality-of-life questionnaires.
Post-treatment evaluations:
- Clinic visits at months 1, 3, 6, 12, 15, 18 and 21 for physical examination and disease assessment.
- End-of-study visit for blood tests, vital signs and weight measurements, disease assessment, electrocardiogram, pregnancy test for women who can become pregnant
Detailed description
Background:
SS1P (dsFv) PE38, is a recombinant immunotoxin targeting the tumor antigen mesothelin that is highly expressed in malignant mesothelioma. The maximum tolerated dose (MTD) of SS1 dsFv has been established in a phase I study.
Combination therapy with pemetrexed plus cisplatin is the standard first line therapy for malignant mesothelioma, but results in a median overall survival of only 12.1 months.
Combination of SS1(dsFv)PE38 with pemetrexed plus cisplatin could result in improved outcomes for patients with mesothelioma.
Objectives:
To determine the MTD of SS1(dsFv)PE38 that can be safely administered in combination with pemetrexed plus cisplatin in patients with mesothelioma.
To characterize the toxicity profile of SS1(dsFv)PE38.
To study the pharmacokinetics of SS1(dsFv)PE388.
To observe anti-tumor activity, if any of SS1(dsFv)PE38 in combination with pemetrexed plus cisplatin.
Eligibility:
Subjects with histologically confirmed epithelial pleural mesothelioma.
No prior radiotherapy (except palliative localized radiotherapy),systemic chemotherapy or biologic therapy for pleural mesothelioma.
Design:
This is a phase I dose-escalation study of SS1(dsFv)PE38 in combination with pemetrexed plus cisplatin.
The dose of pemetrexed plus cisplatin will be the standard dose approved for malignant mesothelioma. The dose of SS1(dsFv)PE38 will be escalated to find the safe dose in combination with pemetrexed plus cisplatin.
SS1(dsFv)PE38 will be administered concurrently with pemetrexed plus cisplatin in cycles one and two, and subjects will receive additional cycles of pemetrexed and cisplatin as per standard practice.
Patients will be assessed for response every 6 weeks.
An additional Single Cycle of SS1(dsFv)PE38 Cohort will involve up to 16 patients who will receive SS1(dsFv)PE38 administered for four or five doses during the first cycle concurrently with pemetrexed and cisplatin; subjects in this cohort will receive additional
cycles of pemetrexed and cisplatin as per standard practice
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Multicycle SS1P, Drug: Pemetrexed, Drug: CisplatinMulti-cycle cohort |
| 2 | Experimental | Drug: Pemetrexed, Drug: Cisplatin, Biological: Single cycle SS1PSingle cycle cohort |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects must meet all of the following criteria to be eligible to participate in the study:
- Subjects must have histologically confirmed epithelial or biphasic pleural mesothelioma not amenable to potentially curative surgical resection. However, patients with biphasic tumors that have a predominantly sarcomatoid component will be excluded.
- Measurable disease
- Subjects must be greater than or equal to 18 years old
- Karnofsky Performance Status (KPS) of greater than or equal to 70
Key exclusion criteria (12 listed)
- Subjects must not be pregnant or breast feeding
- Prior radiotherapy (except palliative extra-thoracic localized radiotherapy) or biologic therapy for malignant pleural mesothelioma within 4 weeks
- Prior systemic chemotherapy for malignant pleural mesothelioma
- Documented and ongoing central nervous system involvement with their malignant disease (history of CNS involvement is not an exclusion criterion but the CNS metastases should have been adequately treated (radiation or surgical resection) and subjects are free from symptoms for 3 months off steroids).
- Clinically significant heart disease (New York Heart Association Class III or IV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicycle SS1PAssigned dose level of SS1(dsFv)PE38 on days 1, 3 \& 5 of a 21 day cycle for 2 cycles | Biological | 1 |
| Pemetrexed500 mg/m^2 on day 1 of each 21 day cycle until disease progression | Drug | 1, 2 |
| Cisplatin75 mg/m^2 on day 1 of each 21 day cycle until disease progression | Drug | 1, 2 |
| Single cycle SS1PPatients 1 - 3 of single cycle cohort. 45 mcg/kg of SS1(dsFv)PE38 on 4 or 5 days (depending on dose level) of cycle 1 only. | Biological | 2 |
Primary outcome
Safety and MTD
Time frame: 30 days after last dose
list of adverse events and highest dose at which fewer than 2 subjects experienced DLT
Best overall response
Time frame: Assessed every 42 days until disease progression
proportion of subjects experiencing complete response, partial response or stable disease as a best overall response
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Background: PubMed 8552591Chang K, Pastan I. Molecular cloning of mesothelin, a differentiation antigen present on mesothelium, mesotheliomas, and ovarian cancers. Proc Natl Acad Sci U S A. 1996 Jan 9;93(1):136-40. doi: 10.1073/pnas.93.1.136.
- Background: PubMed 1244564Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.
- Background: PubMed 16082249Hassan R, Kreitman RJ, Pastan I, Willingham MC. Localization of mesothelin in epithelial ovarian cancer. Appl Immunohistochem Mol Morphol. 2005 Sep;13(3):243-7. doi: 10.1097/01.pai.00000141545.36485.d6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffit Hassan, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Multicycle SS1P, Pemetrexed and Cisplatin in people with Mesothelioma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and MTD (time frame: 30 days after last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01445392, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.