NY-ESO-1-expressing TumorsPhase 1NCT00819806
CpG 7909/Montanide ISA 720 With or Without Cyclophosphamide in Combination Either With NY-ESO-1-derived Peptides or the NY-ESO-1 Protein for NY-ESO-1-expressing Tumors
A Phase 1 study testing Vaccine only and Vaccine + cyclophosphamide in people with NY-ESO-1-expressing Tumors, run by Hassane M. Zarour, MD at 1 site in United States.
Trial summary
Subjects will receive immunizations every other week for 8 immunizations prior to clinical and immunological evaluations. Patients will then receive immunizations every month up to one year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NY-ESO-1-expressing Tumors
- What is being tested?
- Vaccine only and Vaccine + cyclophosphamide
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jan 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained prior to the initiation of study procedures.
- Male and female subjects >= 18 years of age.
- Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
- Tumor must express NY-ESO-1 as determined by RT-PCR or immunohistochemistry. Subjects with anti-NY-ESO-1 antibodies measured by ELISA, will also be eligible for this trial.
- No specific HLA expression required but we will systematically perform for each patient genotypic HLA typing.
- Negative serology tests for HIV 1 and 2, Hepatitis B and C.
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- Adequate hematologic, renal, and liver function as evidenced by the following: - WBC >= 3,000 / mm3; - lymphocytes >= 1,000 / mm3; - platelets >= 100,000 / mm3; - serum creatinine <= 1.5 x upper limit of normal (ULN); - Serum Bilirubin <= 1.5 x ULN; - Serum AST / ALT <= 2.5 x ULN.
- Subjects with stage III/IV cancer will be eligible after they have progressed after receiving any available and well-established life-prolonging therapy.
- Subjects with melanoma must have histologically confirmed measurable Stage III or Stage IV melanoma (according to the current AJCC 6th edition classification). Cutaneous, ocular and mucosal melanoma will be eligible.
- Subjects with Stage III or Stage IV prostate cancers who have received and not responded to radiation therapy, surgery (if applicable) and hormonal therapy, and are hormone-refractory. Subjects must have two consecutive PSA values, at least 14 days apart, each >= 5 ng/ml and >= 50% above the minimum PSA observed during castration therapy or above the pretreatment value if there was no response.
- Subjects with Stage III or Stage IV breast cancers who have received and not responded to radiation therapy (if applicable), hormonal therapy (if ER+) and two regimens of standard chemotherapy.
- Subjects with Stage III or Stage IV NSCLC lung cancers who have received and not responded to radiotherapy (if applicable), surgery (if applicable), and at least one regimen of standard chemotherapy.
- Subjects with locally advanced metastatic bladder cancers who have received and not responded to radical cystectomy (if applicable), radiation therapy (if applicable), and at least one combination chemotherapy regimen.
- Subjects with Stage III or Stage IV head and neck cancers who have received and not responded to radiotherapy, surgery, and at least one regimen of chemotherapy combinations.
- Subjects with Stage III or Stage IV soft tissue sarcomas who have received and not responded to radiotherapy, surgery, and at least one regimen of chemotherapy combinations.
- Subjects with Stage III or Stage IV ovarian cancer who have received and progressed after surgery and at least one regimen of standard chemotherapy combinations.
- Subject with Stage III multiple myeloma who have received at least two regimens for relapsed and / or refractory multiple myeloma including bortezomib or velcade.
- Subjects must have fully recovered from surgery, and must not have received any chemotherapy, hormonal therapy, radiotherapy, or biological therapy within the preceding 4 weeks.
- Life expectancy of at least 6 months.
- WHO Performance Status of 0 or 1.
- Normal titers for ANA (<= 1/80) and anti-ds DNA (<= 1/10). Patients with elevated titers of ANAs (> 1/80) or anti-ds DNA (>1/10) will be excluded from protocol only if they have symptoms of active auto-immune disease as assessed by specialized consultation (rheumatologist).
- Subjects need to have recovered from any effects of previous treatments (recovery must have been documented for at least 1 week prior to treatment on this study).
- Subjects must be free of brain metastasis by contrast-enhanced CT/MRI scans or have brain metastasis and: the total number of brain metastasis is <=3; each brain metastasis must have been either completely removed by surgery of treated with stereotactic radiosurgery (gamma knife); the subject must be asymptomatic for more than 1 month.
- Female subjects of child bearing potential must have a negative pregnancy test, and must not be breast feeding.
- Subjects must agree to use effective contraception (both males and females). We have decided to include patients with NY-ESO-1-expressing tumors of different histological types and not only melanoma as we have previously done in the ongoing trial UPCI 00-079. The reasons are several-fold. First, we do not expect that the type of disease will have an impact on the main objectives (i.e. safety, toxicity and immunological). Second, we feel it is important to be able to include all eligible cancer patients with no available therapeutic option and who are willing to be included in a novel investigative trial. Finally, our experience with the ongoing trial UPCI 00-079 leads us to think that the large majority of patients will be melanoma patients (17 patients included to date, including 16 melanoma patients and one sarcoma patient).
Who cannot join
- Subjects with prostate cancer who demonstrate an anti-androgen withdrawal response, defined as a >= 25% drop in PSA within 4 weeks (flutamide) or six week (nilutamide, bicalutamide) of stopping a non-steroidal anti-androgen are not eligible until the PSA rises above the nadir observed after anti-androgen withdrawal.
- Serious illnesses, such as: cardiovascular disease (uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, severe cardia arrhythmia), bleeding disorders, autoimmune diseases, severe obstructive or restrictive pulmonary diseases, active systemic infections, inflammatory bowel disorders, severe renal disease.
- Any significant psychiatric disease, medical intervention, or other condition, which in the opinion of the principal investigator, could prevent adequate informed consent or compromise participation in the clinical trial.
- Active infection or antibiotics within one-week prior to study, including unexplained fever (temp > 38.1 degree C).
- Treatment with nitrosources within 6 weeks prior to enrollment.
- Systemic steroid or other immunosuppressive therapy > 10 days within 4 weeks of enrollment.
- A requirement for systemic immunosuppressive therapy > 5 days developing during the trial will result in the subject being removed from the study.
- Treatment with any investigational immunization with CpG 7909 and NY-ESO-1 peptides of NY-ESO-1 protein within two years of registration or treatment with any other investigational product within 28 days of registration.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hillman Cancer Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Phase I Study of Vaccination With CpG 7909 and Montanide ISA 720 With or Without Cyclophosphamide in Combination Either With NY-ESO-1-derived Peptides or the NY-ESO-1 Protein in Patients With NY-ESO-1-expressing Tumors
Subjects will receive immunizations every other week for 8 immunizations prior to clinical and immunological evaluations. Patients will then receive immunizations every month up to one year. Cyclophosphamide will be administered intravenously 3 days prior to the first immunization, 3rd, 5th, 7th, 9th, and subsequent monthly immunizations. Women and men >= 18 years of age with refractory metastatic malignancies that express NY-ESO-1 by RT-PCR or immunohistochemistry. Alternatively, patients may be elected on the basis of serum anti-NY-ESO-!-antibodies as detected by ELISA.
Primary Objective: To evaluate the toxicity profile of the regimens described in Section 1.6.
Read more
Secondary Objective: To detect and quantitate immune responses induced by the proposed peptide vaccine or protein vaccine in association with CpG 7909 and cyclophosphamide. This endpoint will be assessed by an IFN-y ELISPOT assay of NY-ESO-1-specific tumor-reactive CD8 + T cells. We also will look for NY-ESO-1 tetramer CD8+ T cells, Delayed-type Hypersensitivity (DTH), and NY-ESO-1-specific CD4+ T cell responses with ELISPOT assays and cytokine-release-assays.
Tertiary Objectives: To evaluate tumor response in terms of clinical tumor regression and progression-free interval. To evaluate the survival of patients treated with the regimens described in Section 1.6.
The first 3 patients will be assigned treatment A. All three patients will be treated and observed for one month. If no DLTs are observed in the first 3 patients, accrual to arm A will be put on hold and accrual will continue with Arm B. However, if 1 DLT is observed in Arm A, up to 3 additional patients will be treated on Arm A, until either 2 DLTs have been observed, or 6 patients have been treated with just 1 DLT among them. If 2 DLTs are observed in Arm A, the study will terminate and all treatments will be deemed intolerable. The same principles apply to the cohorts treated on B-E: if the number of DLTs (after one month of treatment) is zero, accrual proceeds to the next treatment group; if it is 1, accrual continues with the same treatment for up to 3 additional patients; if it is 2, no patients will be treated on the remaining treatment arms.
- Conditions
- NY-ESO-1-expressing Tumors
- Being tested
- Vaccine only, Vaccine + cyclophosphamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine onlyBiological
PF-3512676, Montanide ISA 720 VG and MHC class I peptides from NY-ESO-1 (NY-ESO-1 157-165V, NY-ESO-1 53-62 (MPS-190) and NY-ESO-1 94-102) in three subcutaneous injections (i.e., 1mg of PF-3512676 at 15mg/ml and 50 μg of each peptide (2mg/ml) for each of the three injections + Montanide ISA 720 VG + saline). The final volume of immunization will be 4.5 ml administered as 3 separate 1.5 ml subcutaneous injections. The remaining 1.5 ml will be used for sterility testing. Each injection will be done in the vicinity of the nodal drainage of one extremity.
Vaccine + cyclophosphamideBiological
PF-3512676, Montanide ISA 720 VG and three MHC class I-restricted epitopes from NY-ESO-1 (NY-ESO-1 157-165V, NY-ESO-1 53-62 (MPS-190) and NY-ESO-1 94-102) and cyclophosphamide. The vaccine preparation is identical to arm A. Each injection will be done in the vicinity of the nodal drainage of one extremity. Each will consist of 1.5 ml of product. Low-dose cyclophosphamide (300mg/m2) will be given IV, monthly, 3 days prior to the first, 3rd, 5th, 7th, 9th, and subsequent monthly immunizations.
Vaccine onlyBiological
PF-3512676, Montanide ISA 720 VG and three MHC class I epitopes (NY-ESO-1 157-165V, NY-ESO-1 53-62 and NY-ESO-1 94-102) and three MHC class II epitopes (NY-ESO-1 87-111, NY-ESO-1 119-143 and NY-ESO-157-170) in three subcutaneous injections (i.e., 1mg of PF-3512676 at 15mg/ml and 50 μg of each peptide (2mg/ml) for each of the three injections + Montanide ISA 720 VG + saline). The final volume of immunization will be 4.5 ml administered as 3 separate 1.5 ml subcutaneous injections. Each injection will be done in the vicinity of the nodal drainage of one extremity. Each will consist of 1.5 ml of product.
Vaccine + cyclophosphamideBiological
PF-3512676, Montanide ISA 720 VG and three MHC class I epitopes (NY-ESO-1 157-165V, NY-ESO-1 53-62 and NY-ESO-1 94-102), three MHC class II epitopes (NY-ESO-1 87-111, NY-ESO-1 119-143 and NY-ESO-157-170) and cyclophosphamide. The vaccine preparation is identical to arm C. Low-dose cyclophosphamide (300mg/m2) IV will be given IV, monthly, 3 days prior to the first, 3rd, 5th, 7th, 9th, and subsequent monthly immunizations.
Vaccine onlyBiological
PF-3512676, Montanide ISA 720 VG and the NY-ESO-1 protein in three subcutaneous injection (i.e. 3 mg of PF-3512676 or 300 μl of PF-3512676 at 10mg/ml, 300 μg or 900 μl of protein NY-ESO-1 at 0.35 mg/ml + Montanide ISA 720 VG). The final volume of immunization will be 4.5 ml administered as 3 separate 1.5 ml SC injections. Each injection will be done in the vicinity of the nodal drainage of one extremity. Each will consist of 1.5 ml of product.
Vaccine + cyclophosphamideBiological
PF-3512676, Montanide ISA 720 VG and the NY-ESO-1 protein in three subcutaneous injections and cyclophosphamide. The vaccine preparation is identical to arm E. Low-dose cyclophosphamide (300mg/m2) will be given IV, monthly, 3 days prior to the first, 3rd, 5th, 7th, 9th, and subsequent monthly immunizations.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | PF-3512676, and three MHC class I Montanide ISA 720 VG and the peptides NY-ESO-1 157-165V, NY-ESO-1 53-62 and NY-ESO-1 94-102 will be administered in three separate subcutaneous (under the skin) injections. Receives: Biological: Vaccine only |
| B | Experimental | This vaccine injection contains all the same components of Arm A and will also be administered in 3 separate subcutaneous injections. However, 3 days prior to your 1st, 3rd, 5th, 7th, 9th and subsequent monthly vaccinations, you will have low-dose cyclophosphamide administered intravenously (through a vein in your arm). Cyclophosphamide is an agent that is thought to increase the anti-tumor response of vaccines. Receives: Biological: Vaccine + cyclophosphamide |
| C | Experimental | PF-3512676, Montanide ISA 720 VG and the peptides NY-ESO-1 157-165V, NY-ESO-1 53-62 and NY-ESO-1 94-102, NY-ESO-1 87-111, NY-ESO-1 119-143 and NY-ESO-1 157-170 will be administered in three separate subcutaneous injections. Receives: Biological: Vaccine only |
| D | Experimental | This vaccine injection contains all the same components of Arm C and will also be administered in 3 separate subcutaneous injections. However, 3 days prior to your 1st, 3rd, 5th, 7th, 9th and subsequent monthly vaccinations, you will have low-dose cyclophosphamide administered intravenously (through a vein in your arm). Receives: Biological: Vaccine + cyclophosphamide |
| E | Experimental | PF-3512676, Montanide ISA 720 VG and the NY-ESO-1 protein will be administered in three separate subcutaneous injections. Receives: Biological: Vaccine only |
| F | Experimental | This vaccine injection contains all the same components of Arm E and will also be administered in 3 separate subcutaneous injections. However, 3 days prior to your 1st, 3rd, 5th, 7th, 9th and subsequent monthly vaccinations, you will have low-dose cyclophosphamide administered intravenously (through a vein in your arm). Receives: Biological: Vaccine + cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity profile of the 6 regimens
Measured: 4 years
Secondary outcomes (2)
Detect and quantitate immune responses
Measured: 4 years
Evaluate tumor response
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2012
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NY-ESO-1-expressing TumorsStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hassane M. Zarour, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Hassane M. Zarour, MD, University of Pittsburgh
- Investigators
- Hassane M Zarour, MD, Principal investigator, UPCI/UPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819806
- Sponsor's protocol ID
- 05-140
- Other IDs
- 1R01CA112198-01
- Status last verified
- Jul 2017
- First submitted
- 7 Jan 2009
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Vaccination With CpG 7909 and Montanide ISA 720 With or Without Cyclophosphamide in Combination Either With NY-ESO-1-derived Peptides or the NY-ESO-1 Protein in Patients With NY-ESO-1-expressing Tumors
- ClinicalTrials.gov ID
- NCT00819806
- Acronym / sponsor ID
- 05-140
- Conditions
- NY-ESO-1-expressing Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hassane M. Zarour, MDUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 9 Jan 2009 (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.
Subjects will receive immunizations every other week for 8 immunizations prior to clinical and immunological evaluations. Patients will then receive immunizations every month up to one year. Cyclophosphamide will be administered intravenously 3 days prior to the first immunization, 3rd, 5th, 7th, 9th, and subsequent monthly immunizations. Women and men >= 18 years of age with refractory metastatic malignancies that express NY-ESO-1 by RT-PCR or immunohistochemistry. Alternatively, patients may be elected on the basis of serum anti-NY-ESO-!-antibodies as detected by ELISA.
Primary Objective: To evaluate the toxicity profile of the regimens described in Section 1.6.
Secondary Objective: To detect and quantitate immune responses induced by the proposed peptide vaccine or protein vaccine in association with CpG 7909 and cyclophosphamide. This endpoint will be assessed by an IFN-y ELISPOT assay of NY-ESO-1-specific tumor-reactive CD8 + T cells. We also will look for NY-ESO-1 tetramer CD8+ T cells, Delayed-type Hypersensitivity (DTH), and NY-ESO-1-specific CD4+ T cell responses with ELISPOT assays and cytokine-release-assays.
Tertiary Objectives: To evaluate tumor response in terms of clinical tumor regression and progression-free interval. To evaluate the survival of patients treated with the regimens described in Section 1.6.
The first 3 patients will be assigned treatment A. All three patients will be treated and observed for one month. If no DLTs are observed in the first 3 patients, accrual to arm A will be put on hold and accrual will continue with Arm B. However, if 1 DLT is observed in Arm A, up to 3 additional patients will be treated on Arm A, until either 2 DLTs have been observed, or 6 patients have been treated with just 1 DLT among them. If 2 DLTs are observed in Arm A, the study will terminate and all treatments will be deemed intolerable. The same principles apply to the cohorts treated on B-E: if the number of DLTs (after one month of treatment) is zero, accrual proceeds to the next treatment group; if it is 1, accrual continues with the same treatment for up to 3 additional patients; if it is 2, no patients will be treated on the remaining treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: Vaccine onlyPF-3512676, and three MHC class I Montanide ISA 720 VG and the peptides NY-ESO-1 157-165V, NY-ESO-1 53-62 and NY-ESO-1 94-102 will be administered in three separate subcutaneous (under the skin) injections. |
| B | Experimental | Biological: Vaccine + cyclophosphamideThis vaccine injection contains all the same components of Arm A and will also be administered in 3 separate subcutaneous injections. However, 3 days prior to your 1st, 3rd, 5th, 7th, 9th and subsequent monthly vaccinations, you will have low-dose cyclophosphamide administered intravenously (through a vein in your arm). Cyclophosphamide is an agent that is thought to increase the anti-tumor response of vaccines. |
| C | Experimental | Biological: Vaccine onlyPF-3512676, Montanide ISA 720 VG and the peptides NY-ESO-1 157-165V, NY-ESO-1 53-62 and NY-ESO-1 94-102, NY-ESO-1 87-111, NY-ESO-1 119-143 and NY-ESO-1 157-170 will be administered in three separate subcutaneous injections. |
| D | Experimental | Biological: Vaccine + cyclophosphamideThis vaccine injection contains all the same components of Arm C and will also be administered in 3 separate subcutaneous injections. However, 3 days prior to your 1st, 3rd, 5th, 7th, 9th and subsequent monthly vaccinations, you will have low-dose cyclophosphamide administered intravenously (through a vein in your arm). |
| E | Experimental | Biological: Vaccine onlyPF-3512676, Montanide ISA 720 VG and the NY-ESO-1 protein will be administered in three separate subcutaneous injections. |
| F | Experimental | Biological: Vaccine + cyclophosphamideThis vaccine injection contains all the same components of Arm E and will also be administered in 3 separate subcutaneous injections. However, 3 days prior to your 1st, 3rd, 5th, 7th, 9th and subsequent monthly vaccinations, you will have low-dose cyclophosphamide administered intravenously (through a vein in your arm). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Written informed consent obtained prior to the initiation of study procedures.
- Male and female subjects >= 18 years of age.
- Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
- Tumor must express NY-ESO-1 as determined by RT-PCR or immunohistochemistry. Subjects with anti-NY-ESO-1 antibodies measured by ELISA, will also be eligible for this trial.
- No specific HLA expression required but we will systematically perform for each patient genotypic HLA typing.
Key exclusion criteria (8 listed)
- Subjects with prostate cancer who demonstrate an anti-androgen withdrawal response, defined as a >= 25% drop in PSA within 4 weeks (flutamide) or six week (nilutamide, bicalutamide) of stopping a non-steroidal anti-androgen are not eligible until the PSA rises above the nadir observed after anti-androgen withdrawal.
- Serious illnesses, such as: cardiovascular disease (uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, severe cardia arrhythmia), bleeding disorders, autoimmune diseases, severe obstructive or restrictive pulmonary diseases, active systemic infections, inflammatory bowel disorders, severe renal disease.
- Any significant psychiatric disease, medical intervention, or other condition, which in the opinion of the principal investigator, could prevent adequate informed consent or compromise participation in the clinical trial.
- Active infection or antibiotics within one-week prior to study, including unexplained fever (temp > 38.1 degree C).
- Treatment with nitrosources within 6 weeks prior to enrollment.
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 |
|---|---|---|
| Vaccine onlyPF-3512676, Montanide ISA 720 VG and MHC class I peptides from NY-ESO-1 (NY-ESO-1 157-165V, NY-ESO-1 53-62 (MPS-190) and NY-ESO-1 94-102) in three subcutaneous injections (i.e., 1mg of PF-3512676 at 15mg/ml and 50 μg of each peptide (2mg/ml) for each of the three injections + Montanide ISA 720 VG + saline). The final volume of immunization will be 4.5 ml administered as 3 separate 1.5 ml subcutaneous injections. The remaining 1.5 ml will be used for sterility testing. Each injection will be done in the vicinity of the nodal drainage of one extremity. | Biological | A |
| Vaccine + cyclophosphamidePF-3512676, Montanide ISA 720 VG and three MHC class I-restricted epitopes from NY-ESO-1 (NY-ESO-1 157-165V, NY-ESO-1 53-62 (MPS-190) and NY-ESO-1 94-102) and cyclophosphamide. The vaccine preparation is identical to arm A. Each injection will be done in the vicinity of the nodal drainage of one extremity. Each will consist of 1.5 ml of product. Low-dose cyclophosphamide (300mg/m2) will be given IV, monthly, 3 days prior to the first, 3rd, 5th, 7th, 9th, and subsequent monthly immunizations. | Biological | B |
| Vaccine onlyPF-3512676, Montanide ISA 720 VG and three MHC class I epitopes (NY-ESO-1 157-165V, NY-ESO-1 53-62 and NY-ESO-1 94-102) and three MHC class II epitopes (NY-ESO-1 87-111, NY-ESO-1 119-143 and NY-ESO-157-170) in three subcutaneous injections (i.e., 1mg of PF-3512676 at 15mg/ml and 50 μg of each peptide (2mg/ml) for each of the three injections + Montanide ISA 720 VG + saline). The final volume of immunization will be 4.5 ml administered as 3 separate 1.5 ml subcutaneous injections. Each injection will be done in the vicinity of the nodal drainage of one extremity. Each will consist of 1.5 ml of product. | Biological | C |
| Vaccine + cyclophosphamidePF-3512676, Montanide ISA 720 VG and three MHC class I epitopes (NY-ESO-1 157-165V, NY-ESO-1 53-62 and NY-ESO-1 94-102), three MHC class II epitopes (NY-ESO-1 87-111, NY-ESO-1 119-143 and NY-ESO-157-170) and cyclophosphamide. The vaccine preparation is identical to arm C. Low-dose cyclophosphamide (300mg/m2) IV will be given IV, monthly, 3 days prior to the first, 3rd, 5th, 7th, 9th, and subsequent monthly immunizations. | Biological | D |
| Vaccine onlyPF-3512676, Montanide ISA 720 VG and the NY-ESO-1 protein in three subcutaneous injection (i.e. 3 mg of PF-3512676 or 300 μl of PF-3512676 at 10mg/ml, 300 μg or 900 μl of protein NY-ESO-1 at 0.35 mg/ml + Montanide ISA 720 VG). The final volume of immunization will be 4.5 ml administered as 3 separate 1.5 ml SC injections. Each injection will be done in the vicinity of the nodal drainage of one extremity. Each will consist of 1.5 ml of product. | Biological | E |
| Vaccine + cyclophosphamidePF-3512676, Montanide ISA 720 VG and the NY-ESO-1 protein in three subcutaneous injections and cyclophosphamide. The vaccine preparation is identical to arm E. Low-dose cyclophosphamide (300mg/m2) will be given IV, monthly, 3 days prior to the first, 3rd, 5th, 7th, 9th, and subsequent monthly immunizations. | Biological | F |
Primary outcome
Toxicity profile of the 6 regimens
Time frame: 4 years
2 secondary outcomes
Detect and quantitate immune responses
Time frame: 4 years
Evaluate tumor response
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
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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.
Hassane M Zarour, MD principal investigator
UPCI/UPMC
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 Vaccine only and Vaccine + cyclophosphamide in people with NY-ESO-1-expressing Tumors, run by Hassane M. Zarour, MD 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 25 inclusion and 8 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: finished, as of the sponsor's last update on 31 Jul 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Toxicity profile of the 6 regimens (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2017.