Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Biological: pTVG-HP; Biological: rhGM-CSF

Study type: Interventional

Funder types: Other

Identifiers

NCT01341652

Protocol Version 10/7/2015 (Other Identifier)

CO08801

NCI-2011-00965 (Registry Identifier)

SMPH/MEDICINE/MEDICINE*H (Other Identifier)

A534260 (Other Identifier)

2013-1679 (Other Identifier)

Details and patient eligibility

About

The investigators are trying to find new methods to treat prostate cancer. The approach the investigators are taking is to try to enhance patients' own immune response against the cancer. In this study the investigators will be testing the effectiveness of a vaccine that may be able to help the body fight prostate cancer.

Enrollment: 99 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic diagnosis of adenocarcinoma of the prostate
• Completion of local therapy by surgery and/or ablative radiation therapy at least 3 months prior to entry, with removal or ablation of all visible disease, including seminal vesical and/or local lymph node involvement
• Rising prostate specific antigen (PSA) levels without scan evidence of metastatic disease
• Asymptomatic or mildly symptomatic and life expectancy of at least 4 months

Exclusion criteria

• Small cell or other variant prostate cancer histology
• Evidence of immunosuppression
• Prior treatment with androgen deprivation except if given neoadjuvantly or adjuvantly with radiation therapy or at time of prostatectomy. In this situation, no more than 24 months of androgen deprivation must have been given and treatment must not have been within 12 months prior to screening for this study.
• Serum testosterone at screening < 50 ng/dL
• Known bone metastases or lymph node involvement as determined by bone scan or computed tomography (CT) scan of the abdomen and pelvis within 4 weeks of study entry
• Prior vaccine therapy for prostate cancer
• Known allergic reactions to granulocyte-macrophage colony-stimulating factor (GM-CSF)
• Severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the Medical Monitor, excess risk associated with study participation or study agent administration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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99 participants in 2 patient groups

pTVG-HP vaccine with GM-CSF

Experimental group

Description:

pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period

Treatment:

Biological: pTVG-HP

GM-CSF alone

Active Comparator group

Description:

rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period

Treatment:

Biological: rhGM-CSF