Sipuleucel-T Manufacturing Demonstration Study

Conditions: Therapeutic area: Diseases [C] - Cancer [C04]
MedDRA version: 14.1Level: LLTClassification code 10036916Term: Prostate cancer stage DSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1Level: LLTClassification code 10036910Term: Prostate cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1Level: LLTClassification code 10066489Term: Progression of prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
metastatic castrate resistant prostate cancer
MedDRA version: 14.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Registration Number: EUCTR2011-001192-39-NL

Lead Sponsor: Dendreon Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 45

Inclusion Criteria

1 Written informed consent obtained prior to the initiation of study procedures.
2 Males, age = 18 years at time of registration.
3 Histologically documented adenocarcinoma of the prostate.
4 Metastatic disease as evidenced by soft tissue and/or bony metastases on bone scan and/or computed tomography (CT) scan of the abdomen and pelvis at any time prior to registration.
5 Castrate resistant prostate cancer. Subjects must have current or historical evidence of disease progression concomitant with surgical or medical castration, as demonstrated by PSA progression OR progression of measurable disease OR progression of non-measurable disease.
6 Serum PSA = 5.0 ng/mL.
7 Castration levels of testosterone (= 50 ng/dL; = 1.74 nmol/L) achieved via medical or surgical castration.
8 ECOG performance status = 1 (see Appendix 1).
9 Adequate hematologic, renal, and liver function.
10 Negative serology tests indicating no active infection with human immunodeficiency virus types 1 and 2 (HIV-1/2), human T cell lymphotropic virus types 1 and 2 (HTLV-I/II), and Hepatitis B and C viruses.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1 The presence of known brain metastases. In the case of suspected or questionable findings, the Investigator must address each finding in the subject’s medical record prior to registration.
2 A requirement for systemic immunosuppressive therapy for any reason.
3 Treatment with any investigational vaccine within 2 years prior to registration.
4 Any previous treatment with sipuleucel T.
5 Any previous treatment with ipilimumab (Yervoy™, MDX-010, or MDX-101) or denosumab (Xgeva™).
6 Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%), or spinal cord compression.
7 Subject with known malignancies other than prostate cancer that are likely to require treatment within 6 months of registration.
8 A history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel T or GM-CSF.
9 More than 2 chemotherapy regimens at any time prior to registration.
10 Treatment with chemotherapy within 90 days of registration.
11 Received granulocyte colony-stimulating factor (G-CSF) or GM-CSF within 90 days prior to registration.
12 Treatment with any of the following medications or interventions within 28 days of registration:
•Systemic corticosteroids.
•Non-steroidal anti-androgens (e.g., bicalutamide, flutamide, or nilutamide).
•External beam radiation therapy or major surgery requiring general anesthetic.
•Any other systemic therapy for prostate cancer including secondary hormonal therapies, such as megestrol acetate (Megace®), diethylstilbestrol (DES), and ketoconazole. Medical castration therapy is not exclusionary.
•Immunosuppressive therapy.
•Treatment with any other investigational product.
13 Any infection requiring parenteral antibiotic therapy or causing fever (temperature > 100.5°F or 38.1°C) within 7 days prior to registration.
14 Any medical intervention or other condition which, in the opinion of the Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study’s objectives.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that sipuleucel-T can be successfully manufactured for subjects with mCRPC at a European manufacturing facility.;Secondary Objective: Evaluation of the safety of sipuleucel T produced at a European manufacturing facility. ;Primary end point(s): A descriptive summarization of key product parameters for sipuleucel-T produced at a European manufacturing facility:<br>•CD54+ cell count<br>•Cumulative CD54 upregulation<br>•Cumulative TNC count <br>•Product viability (percentage) <br>;Timepoint(s) of evaluation of this end point: Samples will be collected before and after manufacture of every sipuleucel-T dose

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety will be assessed by summarizing adverse events, laboratory test results, vital sign measurements, ECOG performance status, and physical examination findings;Timepoint(s) of evaluation of this end point: adverse events are solicited at every subject visit and are also documented if reported in between visits<br><br>routine laboratory (safety labs) test are collected at screening and at the completion visit<br><br>physical examinations, vital sign measurements, ECOG performance status are performed at screening, up to 7 days before the 2nd and 3rd leukapheresis procedures, and at the study completion visit<br><br>Vital signs are also collected 30 minutes before the infusion starts and 30 minutes after the infusion ends