Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer



Status:Active, not recruiting
Conditions:Prostate Cancer, Cancer, Cancer, Cancer, Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:12/21/2018
Start Date:June 7, 2013
End Date:January 2019

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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

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

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 a single
site of metastasis delivered one week prior to beginning of sipuleucel-T therapy.

SECONDARY OBJECTIVES:

I. To assess the effect of radiation therapy to single metastasis on immune response
(antibody and T-cell proliferation to prostate acid phosphate [PAP] and fusion protein
PA2024) generated by sipuleucel-T immunotherapy.

II. To assess the effect of external beam radiotherapy to single metastasis on prostate
specific antigen (PSA) response to therapy with sipuleucel-T.

III. To assess the effect of external beam radiotherapy to single metastasis on radiographic
response rate to therapy with sipuleucel-T.

IV. To assess the time from the onset of therapy with sipuleucel-T +/- radiation to the need
for subsequent therapy for prostate cancer.

V. To assess the toxicity associated with sipuleucel-T +/- radiation.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive sipuleucel-T intravenously (IV) over 60 minutes days 22, 36, and 50.

ARM B: Patients undergo external beam radiation therapy in weeks 1-2. Patients also receive
sipuleucel-T as in Arm A.

In both arms, treatment continues in the absence of disease progression or unacceptable
toxicity.

After completion of study treatment, patients are followed up until week 60.

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
We found this trial at
3
sites
2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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Duarte, California 91010
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Pasadena, California 91030
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