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Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer (SCC-EXCITE)

Primary Purpose

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sipuleucel-T
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Castration-Resistant Prostate Cancer (mCRPC) focused on measuring antigen presenting cells (APCs), Sipuleucel-T (Sip-T), granulocyte-macrophage colony-stimulating factor (GM-CSF), prostatic acid phosphatase (PAP)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Men ≥ 18 years of age Prostate cancer with history of metastasis Candidates for Sipuleucel-T treatment are defined as those with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Life expectancy of ≥ 6 months Exclusion Criteria: Previously received Sipuleucel-T (Provenge®) Known malignancies other than prostate cancer likely to require treatment within 6 months following registration A requirement for systemic immunosuppressive therapy (>10mg Prednisone daily or equivalent) A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or GM-CSF Any infection requiring antibiotic therapy within 1 week prior to registration

Sites / Locations

  • Stephenson's Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Extended course of Sipuleucel-T treatment

Arm Description

Outcomes

Primary Outcome Measures

Proportion of patients completing 3 doses of Sipuleucel-T immunotherapy.
Patients will be treated with Sipuleucel-T immunotherapy and the treatment regimen will be considered feasible if 85% of enrolled patients complete all three infusions of Sipuleucel-T treatment given at week 0, 2 and 12-14.
Proportion of subjects who have detectable elevated IgG level and/or T-cell proliferation from baseline to the follow-up of extended course of Sipuleucel-T immunotherapy.
For patients undergoing Sipuleucel-T treatment on weeks 0, 2 and 12-14, the changes in immune response will be measured based on the detectable elevated levels of IgG and/or T-cell proliferation against various types of prostate cancer associated antigens at baseline, and at Sipuleucel-T infusion doses given at week 0, 2 and 12-14 weeks.

Secondary Outcome Measures

Evaluate the mean difference in immune response to Sipuleucel-T treatment among different racial groups.
Potential difference of immune response to Sipuleucel-T immunotherapy given at weeks 0, 2 and 12-14 will be compared in patients with mCRPC of different racial groups using the one-way ANOVA or the Kruskal-Wallis test.
Evaluate the potential tumor response based on the changes in serum PSA at baseline and within 30 days of last dose.
For patients undergoing Sipuleucel-T treatment on weeks 0, 2 and 12-14, the preliminary tumor response will be measure through the comparison of serum PSA level between baseline and within 30 days of last dose.

Full Information

First Posted
March 28, 2023
Last Updated
October 4, 2023
Sponsor
University of Oklahoma
Collaborators
Dendreon
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1. Study Identification

Unique Protocol Identification Number
NCT05806814
Brief Title
Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer
Acronym
SCC-EXCITE
Official Title
Pilot Trial to Investigate Immune Response to an Extended Course of Sipuleucel-T Immunotherapy in Patients With Metastatic Castration-resistant Prostate Cancer (EXCITE Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
Dendreon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Proposed immunotherapy with an extended course of Sipuleucel-T treatment may induce a more robust immune response and improve the anti-cancer efficacy of Sipuleucel-T in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC).
Detailed Description
This open-label, pilot trial aims to evaluate the feasibility of Sipuleucel-T given in three doses at weeks 0, 2, and 12-14; and to investigate the changes in immune response in mCRPC patients who are getting an extended course of Sipuleucel-T treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Keywords
antigen presenting cells (APCs), Sipuleucel-T (Sip-T), granulocyte-macrophage colony-stimulating factor (GM-CSF), prostatic acid phosphatase (PAP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
The primary objective is to evaluate the feasibility and immune response of an extended course of Sipuleucel-T immunotherapy given at week 0, 2, and 12-14 in patients with metastatic castration-resistant prostate cancer.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Extended course of Sipuleucel-T treatment
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Sipuleucel-T
Other Intervention Name(s)
PROVENGE
Intervention Description
Three doses of Sipuleucel-T, each containing a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, given at week 0, 2, and 12-14.
Primary Outcome Measure Information:
Title
Proportion of patients completing 3 doses of Sipuleucel-T immunotherapy.
Description
Patients will be treated with Sipuleucel-T immunotherapy and the treatment regimen will be considered feasible if 85% of enrolled patients complete all three infusions of Sipuleucel-T treatment given at week 0, 2 and 12-14.
Time Frame
up to 5 months
Title
Proportion of subjects who have detectable elevated IgG level and/or T-cell proliferation from baseline to the follow-up of extended course of Sipuleucel-T immunotherapy.
Description
For patients undergoing Sipuleucel-T treatment on weeks 0, 2 and 12-14, the changes in immune response will be measured based on the detectable elevated levels of IgG and/or T-cell proliferation against various types of prostate cancer associated antigens at baseline, and at Sipuleucel-T infusion doses given at week 0, 2 and 12-14 weeks.
Time Frame
up to 12 Months
Secondary Outcome Measure Information:
Title
Evaluate the mean difference in immune response to Sipuleucel-T treatment among different racial groups.
Description
Potential difference of immune response to Sipuleucel-T immunotherapy given at weeks 0, 2 and 12-14 will be compared in patients with mCRPC of different racial groups using the one-way ANOVA or the Kruskal-Wallis test.
Time Frame
up to 12 months
Title
Evaluate the potential tumor response based on the changes in serum PSA at baseline and within 30 days of last dose.
Description
For patients undergoing Sipuleucel-T treatment on weeks 0, 2 and 12-14, the preliminary tumor response will be measure through the comparison of serum PSA level between baseline and within 30 days of last dose.
Time Frame
up to 12 Months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
The study is focused on a prostate cancer-specific group.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men ≥ 18 years of age Prostate cancer with history of metastasis Candidates for Sipuleucel-T treatment are defined as those with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Life expectancy of ≥ 6 months Exclusion Criteria: Previously received Sipuleucel-T (Provenge®) Known malignancies other than prostate cancer likely to require treatment within 6 months following registration A requirement for systemic immunosuppressive therapy (>10mg Prednisone daily or equivalent) A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or GM-CSF Any infection requiring antibiotic therapy within 1 week prior to registration
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lead onco nurse, RN
Phone
405-271-8777
Email
SCCIITOffice@ouhsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Stratton, MD
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stephenson's Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73114
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Stratton, MD
Phone
405-271-6900
Email
Kelly-Stratton@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Kelly Stratton, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer

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