Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer

Metastatic Castration-Resistant Prostate Cancer (mCRPC) Clinical Trial

— OUSCCEXCITE  

Official title:

Pilot Trial to Investigate Immune Response to an Extended Course of Sipuleucel-T Immunotherapy in Patients With Metastatic Castration-resistant Prostate Cancer (OU-SCC-EXCITE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05806814
• Other study ID #: OU-SCC-EXCITE
• Status: Recruiting
• Phase: Phase 1
• Start date: November 12, 2023
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: University of Oklahoma
• Contact: Lead Onco Nurse
• Phone: 405-271-8777
• Email: SCCIITOffice[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men = 18 years of age

2. Prostate cancer with history of metastasis

3. Candidates for Sipuleucel-T treatment are defined as those with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

5. Life expectancy of = 6 months

Exclusion Criteria:

1. Previously received Sipuleucel-T (Provenge®)

2. Known malignancies other than prostate cancer likely to require treatment within 6 months following registration

3. A requirement for systemic immunosuppressive therapy (>10mg Prednisone daily or equivalent)

4. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or GM-CSF

5. Any infection requiring antibiotic therapy within 1 week prior to registration

Related Conditions & MeSH terms

• Metastatic Castration-Resistant Prostate Cancer (mCRPC)
• Prostatic Neoplasms

Intervention

Biological:
• Sipuleucel-T
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.

Locations

Country	Name	City	State
United States	Stephenson's Cancer Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Dendreon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 5 months
Primary	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.	up to 12 Months
Secondary	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.	up to 12 months
Secondary	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.	up to 12 Months