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Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer

NCT01420965 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2019-07-10

Study results available
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Summary

Background:

\- Sipuleucel-T is a new treatment for advanced stage prostate cancer. It takes cells from a person with prostate cancer and treats them in the laboratory. Then it returns the cells to the person to help the immune system fight the cancer. Sipuleucel-T may be combined with the drug CT-011 to boost its ability to kill cancer cells. The chemotherapy drug cyclophosphamide will also be given, either before or after the cells are collected at the start of the treatment.

Objectives:

\- To test the effectiveness of Sipuleucel-T, CT-011, and cyclophosphamide for prostate cancer.

Eligibility:

\- Men at least 18 years of age who have advanced prostate cancer.

Design:

* Participants will be screened with a medical history, physical exam, blood and urine tests, and imaging studies.
* This study has two parts, with different participants in each part. All participants will be monitored with frequent blood tests and imaging studies.
* Part I:
* Participants will provide cells for the Sipuleucel-T treatment three times. The first time will be 3 days before the chemotherapy. The second time will be 10 days after chemotherapy. The third time will be 24 days after chemotherapy.
* Participants will have one dose of cyclophosphamide the day before the first dose of Sipuleucel-T.
* Participants will have Sipuleucel-T about 3 days after each cell donation.
* Part II:
* Participants will be in three groups: Sipuleucel-T given alone, given with CT-011, or given with both cyclophosphamide and CT-011.
* Participants will provide cells for the Sipuleucel-T treatment three times, as in Part I.
* Participants will have Sipuleucel-T about 3 days after each cell donation, and will receive treatment with the other drugs as directed by the study doctors.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

CT-011 (Anti-PD1 Antibody)

Immune Enhancer

OTHER

Sipuleucel-T (Provenge)

Vaccine

DRUG

Cyclophosphamide

Low dose- Immune Enhancer

Sponsors & Collaborators

  • Augusta University

    lead OTHER

Principal Investigators

  • Samir N. Khleif, MD · Augusta University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2016-12-31
Completion
2016-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01420965 on ClinicalTrials.gov