A Phase 2 interventional study of CT-011 (Anti-PD1 Antibody) and Sipuleucel-T (Provenge) in Prostatic Neoplasms, sponsored by Augusta University. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-10.
Sponsored by Augusta University · Phase 2, Interventional, and Treatment
Background:
Objectives:
Eligibility:
Design:
Background:
Objectives:
Eligibility:
Design:
Part 1: Initially the feasibility generating Sipuleucel-T after administration of low dose cyclophosphamide , and will be evaluated using a standard 3 + 3 design for doses of cyclophosphamide 250 mg/m2 or 125 mg/m2. Initially 3 patients will receive cyclophosphamide on day -1 of the first cycle (one day prior to the first infusion of Sipuleucel-T). All patients will receive Sipuleucel-T cell infusion on Day 0. The Sipuleucel-T cell infusion will be repeated every two weeks for a total of three cycles. If Sipuleucel-T active cellular immunotherapy from an apheresis obtained after infusion of cyclophosphamide, which meets the FDA approved Certificate of Analysis (COA) release criteria from Dendreon, cannot be generated, a second apheresis will be performed. Failure of two attempts to generate Sipuleucel-T product after two aphereses at either the 2nd or 3rd scheduled Sipuleucel-T infusion will be considered failure of one patient to meet release criteria .
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 7 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Augusta University is the lead sponsor of 177 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients must have histopathological documentation of prostate cancer prior to starting this study.
Patients must have metastatic progressive castrate-resistant prostate cancer defined as progressive disease (see below) despite surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone. Criteria of progression for trial eligibility are defined from the Prostate Cancer Clinical Trials Working Group-253. Clinically progressive prostate cancer must be evidenced and documented by any of the following parameters:
Progressive measurable disease by RECIST 1.1
Patients on flutamide for at least 6 months must have disease progression at least 4 weeks after withdrawal. Patients on bicalutamide or nilutamide for at least 6 months must have progression at least 6 weeks after withdrawal.2.1.1.4 Performance Status: ECOG 0-1 or Karnofsky 80-100% (asymptomatic or minimally symptomatic from metastatic disease).
No previous chemotherapy use.
No therapeutic immunosuppression or immunomodulation altering bone marrow function within 6 weeks prior to study entry e.g. G-CSF, GM-CSF, EPO, prednisone etc.
Must have adequate:
Must willing and able to sign an informed consent document that explains the neoplastic nature of the disease, the procedures to be followed, the experimental nature of the treatment, alternative treatment and potential risks and toxicities.
EXCLUSION CRITERIA:
Concurrent treatment with any other cancer therapies including radiation (except palliative radiation therapy for bone metastases), chemotherapy or other investigational agent(s). Androgen suppression therapy will be allowed.
History of a second active malignancy in the last 2 years other than non-melanoma skin cancers.
Patients who have active or history of autoimmune disease/symptom/conditions including: type I diabetes, rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis. Type II diabetes mellitus, vitiligo or stable hypothyroidism are not considered exclusion criteria.
Patients being chronically treated with immunosuppressive drugs such as cyclosporin, adrenocorticotropic hormone (ACTH).
Concurrent use of systemic glucocorticoids within 4 weeks prior to trial entry
Patients who have acquired, hereditary, or congenital immunodeficiencies including cellular immunodeficiencies, hypogammaglobulinemia and dysgammaglobulinemia.
CNS, lung, or liver metastasis, because of the poor prognosis, and potential inability to meet study endpoints.
Serious active infection at the time of pre-study screening.
Positive HIV or Hepatitis C antibodies or Hepatitis B anti-core antibodies, because immunotherapies rely on intact immune systems, and toxicities may be exacerbated by the presence of infection.
Sipuleucel-T autologous active cellular immunotherapy only for 3 cycles (cycle = 14 days)
Other: Sipuleucel-T (Provenge)
Sipuleucel-T for 3 cycles (cycle = 14 days) + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion
Drug: CT-011 (Anti-PD1 Antibody) · Other: Sipuleucel-T (Provenge)
Sipuleucel-T for 3 cycles (cycle = 14 days)+ cyclophosphamide (125 or 250mg/m2) IV \[first cycle only\] + CT-011 (3mg/kg) IV infusion delivered over approximately 2 hours, 2 days after each Sipuleucel-T infusion
Drug: CT-011 (Anti-PD1 Antibody) · Other: Sipuleucel-T (Provenge) · Drug: Cyclophosphamide
Immune Enhancer
Also known as: Anti-PD1 Antibody
Vaccine
Also known as: Provenge
Low dose- Immune Enhancer
Also known as: Cytoxan
Determine Feasibility of Provenge Plus Low-dose Cyclophosphamide as Well as the Immune Efficacy of Provenge Alone Versus Provenge Plus Low-dose Cyclophosphamide and Anti PD1 Monoclonal Antibodies (CT011) on the Change in Specific Immune Response.
Time frame: 2 years
Determine Whether the Combination of Low Dose-Cyclophosphamide and Anti PD1 Monoclonal Antibodies (CT-011) With Provenge(tm) Lead to Improvement in Increase Progression Free Survival (PFS) and Overall Survival (OS) in Patients With Advanced, Min...
Time frame: 2 years
| Milestone | Arm A | Arm B | Arm C |
|---|---|---|---|
| Started | 2 | 2 | 3 |
| Completed | 1 | 1 | 3 |
| Not completed | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Withdrew: Adverse event | 0 | 1 | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A | — | 0/2 (0%) | 0/2 (0%) |
| Arm B | — | 1/2 (50%) | 0/2 (0%) |
| Arm C | — | 0/3 (0%) | 0/3 (0%) |
| Event | Arm A | Arm B | Arm C |
|---|---|---|---|
| Negative infusion reactionImmune system disorders | 0/2 | 1/2 | 0/3 |
| Age, Categorical(Participants) | Arm A | Arm B | Arm C | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 3 | 5 |
| >=65 years | 1 | 1 | 0 | 2 |
| Sex: Female, Male(Participants) | Arm A | Arm B | Arm C | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 2 | 2 | 3 | 7 |
| Ethnicity (NIH/OMB)(Participants) | Arm A | Arm B | Arm C | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 2 | 2 | 3 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm A | Arm B | Arm C | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 0 | 1 |
| White | 1 | 1 | 3 | 5 |
| More than one race | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Arm A | Arm B | Arm C | Total |
|---|---|---|---|---|
| United States | 2 | 2 | 3 | 7 |
Plan to share: No
This study is terminated, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Augusta University