Bone Metastases Clinical Trial
Official title:
Randomized Phase II Trial of Sipuleucel T Immunotherapy Preceded by Sensitizing Radiation Therapy and Sipuleucel-T Alone in Patients With Castrate Resistant Metastatic Prostate Cancer
Verified date | June 2019 |
Source | City of Hope Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 the body build an effective immune response to kill tumor cells. Radiation therapy uses high energy x rays to kill tumor cells. It is not yet known whether giving sipuleucel-T vaccine is more effective with or without radiation therapy in treating prostate cancer
Status | Completed |
Enrollment | 51 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | City of Hope Medical Center | Duarte | California |
United States | South Pasadena Cancer Center | Pasadena | California |
United States | Huntsman Cancer Institute, Univ. of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
City of Hope Medical Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free Survival | Estimated using the product-limit method of Kaplan and Meier. Progression is defined as one or more of the following: 20% increase in the sum of the longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesions; PSA increase of 25% from baseline or nadir and by 2ng/uL or greater at 12 weeks; death due to disease without prior documentation of progression and without symptomatic deterioration. |
Until progression or death, Up to 2 years. | |
Secondary | Number of Participants With Grade 2 or Above Adverse Events | Number of participants with specified adverse event that is grade 2 or above and related to treatment. Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 | Up to 60 weeks |
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