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Pilot Trial of Sipuleucel-T, With or Without pTVG-HP DNA Booster Vaccine, in Patients With Castrate-Resistant, Metastatic Prostate Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

Pilot Trial of Sipuleucel-T, With or Without pTVG-HP DNA Booster Vaccine, in Patients With Castrate-Resistant, Metastatic Prostate Cancer


Inclusion Criteria:



- Diagnosis of Prostate Cancer

- Castrate Resistant Disease

- Progressive disease despite androgen deprivation therapy as defined by rising PSA
levels or progressive soft tissue or bony disease

- Normal organ function per laboratory tests

- Life expectancy of at least 6 months

Exclusion Criteria:

- History of life-threatening autoimmune disease

- Small cell or other variant prostate cancer histology

- Serum testosterone at screening < 50 ng/dL

- Prior cytotoxic chemotherapy within 6 months of registration

- Patients who have undergone splenectomy

- Radiation therapy within 4 weeks of registration is prohibited, or anticipated need
for radiation therapy (e.g. imminent pathological fracture or spinal cord
compression) within 3 months of registration.

- Another malignancy other than non-melanoma skin cancer or carcinoma in situ of the
bladder. Subjects with a history of other curatively treated cancers are eligible.

- Known brain metastases

- Any antibiotic therapy or evidence of infection within 1 week of registration

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Measure immune responses following treatment with sipuleucel-T

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Douglas McNeel, M.D., PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Food and Drug Administration

Study ID:

CO11816

NCT ID:

NCT01706458

Start Date:

February 2013

Completion Date:

June 2015

Related Keywords:

  • Prostate Cancer
  • Vaccine
  • pTVG-HP
  • Prostate Cancer
  • Castrate Resistant
  • Prostatic Neoplasms

Name

Location

University of Wisconsin Carbone Cancer Center Madison, Wisconsin  53792-5669