Sipuleucel-T Manufacturing Demonstrating Study
- Conditions
- Metastatic Castrate Resistant Prostate CancerMedDRA version: 16.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0 Level: LLT Classification code 10036910 Term: Prostate cancer NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0 Level: LLT Classification code 10066489 Term: Progression of prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0 Level: LLT Classification code 10036916 Term: Prostate cancer stage D System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0 Level: PT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-001192-39-GB
- Lead Sponsor
- Dendreon Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 47
1.Written informed consent obtained prior to the initiation of study procedures.
2.Males, age = 18 years at the time of registration
3.Histologically documented adinocarcinoma of the prostate.
4. Metastatic diseaseas 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. (Subjects whose metastatic disease is detectable only on chest CT scan are not eligible).
5.Castrate resistant prostate cance, 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 diseae or progression of non-measurable disease as defined below:
- PSA: Two consecutive PSA values, at least 14 days apart, each =5.0 ng/mL and = 50% above the minimum PSA observed during castration therapy or above the pre-treatment value if there was no response.
-Measurable disease: =50% increase in the sum of the cross products of all measurable lesions or the development of any new lesions. The change will be measured
against the best response to castration therapy or against the pre-castration studies if there was no response.
-Non-measurable disease:
-Soft tissue disease: the appearance of 1 or more new lesions, and/or unequivocal worsening of non-measurable disease when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response.
-Bone disease: Apprearance of 2 or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response.Increase uptake of pre-exsisting lesions on bone scan does not constitute progression.
6. Castration levels of testosterone (=50ng/dl; =1.74 nmol/L) achieved via medical or surgical castration. Surgical castration must have occurred at least 3 months prior to registration. Subjects who are not surgically castrated must be receiving medical castration therapy, have initiated such therapy at least 3 months prior to registration, and continue such therapy during their participation on this study.
7.Serum PSA = 5.0 µg/L
8.ECOG performance status =1
9.Adequate hematologic, renal, and liver function as evidenced by the following:
White blood cell count =2,500 cell/µL
Absolute neutrophil count =1000 cell/µL
Platelet count =1000,000 cell/µL
Hemoglobin =10.0g/dL
Creatinine =2.0 mg/dL
Total Bilirubin =2 x Upper limit of normal (ULN)
Aspartate aminotransferase (AST, SGOT) =2.5 x ULN
Alanine aminotransferase (ALT, SGPT) =2.5 x ULN
10. Negative Serology tests indicating no active infection with human immunodeficiency virus types 1 and 2 (HIV -1/2), human T cell lymphotrophic 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
1. The presence of known brain metastases. In the case of suspected or questionable findings, the Investigator must address each findings 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 chemo regimens to any time prior to registration
10. Treatment with any of the following medicated or interventions within 28 days of registration:
-Systemic corticosteroids; use of inhaled, intranasal, intra-articular, and topical steroids is acceptable, as is a short course (i.e. < 1 day) of corticosteroids to prevent a reaction to the IV contract used for CT scans.
-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 porstate cancer including secondary hormonal therapies, such as mogestrol acetate (Megace), diethylstilbestrol (Des), and ketoconazole, medical castration therapy is not exclusionary
-Immunosuppressive therapy
-Treatment with any other investigational product
11. Any injection requiring pareteral antibiotic therapy or causing fever (temp >100.5 °F or 38.1°C) within 7 days prior to registration.
12. Any medical intervention or other condicition 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
- Secondary Outcome Measures
Name Time Method