Status:
COMPLETED
Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Prostate
Bone Metastases
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This randomized phase II trial studies how well giving sipuleucel-T with or without radiation therapy works in treating patients with hormone-resistant metastatic prostate cancer. Vaccines may help th...
Detailed Description
PRIMARY OBJECTIVES: I. To assess the feasibility, based on percent able or willing to receive all three infusions of sipuleucel-T immunotherapy, when combining sipuleucel-T with radiation therapy to ...
Eligibility Criteria
Inclusion
- Histologically documented adenocarcinoma of the prostate
- Life expectancy of \>= 6 months, Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Metastatic disease as evidenced by soft tissue and/or bony metastases on baseline bone scan and/or computed tomography (CT) scan or magnetic resonance imaging (MRI) of the abdomen or pelvis
- Castration resistant prostatic adenocarcinoma; subjects must have current or historical evidence of disease progression despite castrated level of testosterone (\< 50 ng/dL) achieved by orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy; disease progression has to be demonstrated by PSA progression OR progression of measurable disease OR progression of non-measurable disease as defined below:
- PSA: Two consecutive rising PSA values, at least 7 days apart
- Measurable disease: \>= 20% increase in the sum of the longest diameters 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 measurements if there was no response
- Non-measurable disease:
- Soft tissue disease: The appearance of 1 or more 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: Appearance 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; increased uptake of pre-existing lesions on bone scan does not constitute progression
- White blood cell (WBC) \>= 2,500 cells/uL
- Absolute neutrophil count (ANC) \>= 1,000 cells/uL
- Platelet count \>= 75,000 cells/uL
- Hemoglobin (HgB) \>= 9.0 g/dL
- Creatinine =\< 2.5 mg/dL
- Total bilirubin =\< 2 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST, serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT, serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN
- Prior chemotherapy with 0-2 regimens is allowed
- Prior radiation therapy to prostate or prostate bed is allowed provided it occurred \> 3 months before enrollment to the study
Exclusion
- The presence of liver, or known brain metastases, malignant pleural effusions, or malignant ascites
- Moderate or severe symptomatic metastatic disease, defined as a requirement for treatment with opioid analgesics for cancer-related pain within 21 days prior to registration
- Eastern Cooperative Oncology Group (ECOG) performance status \> 2
- Treatment with chemotherapy within 3 months of registration
- Treatment with any of the following medications or interventions within 28 days of registration:
- Systematic corticosteroids; use of inhaled, intranasal, and topical steroids is acceptable
- Any other systemic therapy for prostate cancer (except for medical castration)
- History of external beam radiation therapy to metastatic sites within 1 year of enrollment to the study
- Participation in any previous study involving sipuleucel-T
- Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography \> 50%) or spinal cord compression
- Concurrent other malignancy with the exception of:
- Cutaneous squamous cell and basal carcinomas
- Adequately treated stage 1-2 malignancy
- Adequately treated stage 3-4 malignancy that has been in remission for \>= 2 years at the time of registration
- A requirement for systemic immunosuppressive therapy for any reason
- Any infection requiring parenteral antibiotic therapy or causing fever (temperature \> 100.5 degrees Fahrenheit \[F\] or 38.1 degrees Celsius \[C\]) within 1 week prior to registration
- Any medical intervention or other condition which, in the opinion of the principal investigator could compromise adherence with study requirements or otherwise compromise the study's objectives
Key Trial Info
Start Date :
June 7 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01807065
Start Date
June 7 2013
End Date
December 31 2019
Last Update
August 25 2020
Active Locations (3)
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1
City of Hope Medical Center
Duarte, California, United States, 91010
2
South Pasadena Cancer Center
Pasadena, California, United States, 91030
3
Huntsman Cancer Institute, Univ. of Utah
Salt Lake City, Utah, United States, 84112