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Trial record 1 of 1 for:    NCT01833208
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Radiation Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Receiving Sipuleucel-T

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Roswell Park Cancer Institute
Sponsor:
Collaborators:
Dendreon
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01833208
First received: April 2, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

This pilot clinical trial studies the impact of radiation therapy on the immunogenicity of Sipuleucel-T. Patients with castration recurrent prostate cancer who are eligible for treatment with Sipuleucel-T and who have bone metastases are eligible.


Condition Intervention
Bone Metastases
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Radiation: radiation therapy
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot: Impact of High-Dose, Single Fraction Radiation on Immunogenicity of Sipuleucel-T in Metastatic Castration Recurrent Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Capacity of T cells to proliferate in response to antigen stimulation, assessed with a tritiated thymidine incorporation assay and an IFN-gamma ELISPOT assay [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.

  • Quantification of lymphocyte subsets and NK cells [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.

  • Change in the genetics of immune effectors, measured with RNA from monocytic and lymphocytic cells [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.

  • Change in antigen-specific humoral response measured via ELISA [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: No ]
    Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.


Secondary Outcome Measures:
  • Adverse event rates assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    The Clopper-Pearson one-sided upper 95% confidence limit will be provided. Associations between baseline characteristics and presence of an adverse event (AE) will be considered using the Wilcoxon Rank Sum test (or Cochran-Armitage test for trend) and Fisher's Exact test respectively. Bar charts, scatterplots and other descriptive and graphical methods will also be utilized.

  • Change in PSA [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Will be depicted using Kaplan Meier methods.

  • Cancer-specific survival [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Will be depicted using Kaplan Meier methods.


Estimated Enrollment: 15
Study Start Date: July 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (radiation therapy)
Patients undergo single-fraction radiation therapy to at least 1 bone lesion 2 days after the first sipuleucel-T dose.
Radiation: radiation therapy
Undergo single-fraction radiation therapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess whether radiation therapy (RT) increases the immunogenic potential or sipuleucel-T in patients with castration recurrent prostate cancer.

II. To assess systemic changes to the immune system and genetic changes to immune cells in patients treated by the combination of RT and sipuleucel-T.

III. To assess the induction of antigen-specific immune responses to prostatic acid phosphatase (PAP), cancer/testis antigen 1B (NY-ESO-1) and antigens that have proven to be released by radiation (such as, heat shock protein 90 [HSP-90], calreticulin, etc.).

SECONDARY OBJECTIVES:

I. To assess adverse event rates in patients receiving the high-dose radiation and sipuleucel-T therapy.

II. Prostate-specific antigen (PSA) changes will be assessed. III. Overall and cancer specific survival will be assessed.

OUTLINE:

Patients undergo single-fraction radiation therapy to at least 1 bone lesion 2 days after the first sipuleucel-T dose.

After completion of study treatment, patients are followed up at 3 and 6 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have minimally symptomatic metastatic castration recurrent prostate cancer with bone lesions; this patient population is defined as having failed hormone treatment; minimally symptomatic will be defined as no need for narcotic pain medication
  • Patients that have been prescribed sipuleucel-T and have not started treatment
  • Must be candidates for radiation treatment to bone lesions
  • Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
  • Patients who have received prior radiation of osseous lesions
  • Patients who have received any prior immunotherapy
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the investigator's opinion deems the patient an unsuitable candidate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01833208

Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Roswell Park    877-275-7724    ASKRPCI@roswellpark.org   
Principal Investigator: Thomas Schwaab         
Western New York Urology Recruiting
Cheektowaga, New York, United States, 14225
Contact: Ken Chevli, MD    716-844-5546      
Principal Investigator: Kent Chevli, MD         
Sponsors and Collaborators
Roswell Park Cancer Institute
Dendreon
Investigators
Principal Investigator: Thomas Schwaab Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01833208     History of Changes
Other Study ID Numbers: I 223912, NCI-2013-00633
Study First Received: April 2, 2013
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014