Phase II Study of Adenovirus/PSA Vaccine in Men With Recurrent Prostate Cancer After Local Therapy APP21

NCT00583752 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 201705743200605706
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether vaccination with the Ad/PSA vaccine will induce an anti-PSA immunity that will result in the destruction of the remaining prostate cancer cells.

Conditions

Recurrent Prostate Cancer

Keywords

prostate cancer; vaccine; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Develop a Strong or Modest Anti-PSA Immune Response

  Anti-immunologic response is defined as an increase of \>200% above pre-immunization levels of anti-PSA T cells as measured by ELISPOT analysis

  18 months

Secondary Outcomes (2)

• Number of Participants With Stable, Decreased, or Increased PSA Doubling Times (PSADT)

  18 months

• Number of Participants Alive and Deceased Following Treatment

  Every 6 months, up to 14 years

Study Arms (2)

Androgen deprivation therapy (ADT) + Adenovirus/PSA Vaccine

EXPERIMENTAL

On Arm B, subjects will be started on androgen deprivation therapy (ADT) 14 days prior to beginning the vaccinations.

Biological: Adenovirus/PSA Vaccine

Adenovirus/PSA Vaccine

EXPERIMENTAL

On Arm A, subjects can begin the three vaccinations immediately.

Biological: Adenovirus/PSA Vaccine

Interventions

Adenovirus/PSA Vaccine BIOLOGICAL

1x10E8pfu in Gelfoam subcutaneously on day 0, 30, 60

Adenovirus/PSA Vaccine; Androgen deprivation therapy (ADT) + Adenovirus/PSA Vaccine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men with prostate cancer who have received prior local therapy (radical prostatectomy or definitive radiation therapy) and have biochemical (PSA) relapse without evidence of radiographic or clinical metastatic disease.
• For men who had prior prostatectomy, the surgery must have occurred at least 6 months prior to initiation of treatment.
• For men who had prior definitive radiation therapy, radiation must have been completed at least 1 year prior to initiation of treatment.
• Exhibit at least three separate rises in serum PSA, at least one month apart with differences \>/= 0.03 ng/ml and a total PSA of \>0.2 ng/ml.
• Have a PSA doubling time of \>/= 6 months if the baseline serum PSA was \>2 ng/ml.
• Negative bone scans.
• Negative CT scans of abdomen and pelvis (no evidence of soft tissue lesions \>/= 1 cm).
• Scans must be obtained within 6 weeks of entry into the trial (initiation of treatment).
• Written informed consent.
• Age \>/= 18 years.
• Required laboratory values \[obtained within 2 weeks of study entry (initiation of treatment)\].
• Serum creatinine \</= 2.0 mg/dL
• Adequate hematologic function: granulocytes \>/= 1800 per mm3, platelets \>/= 100,000 per mm3, WBC \>/= 3700, and lymphocytes \>/= 590.
• Adequate hepatocellular function: AST \<3x upper limit of normal and bilirubin \<1.5 mg/dl (unless bilirubin elevation is consistent with Gilbert's syndrome).
• PSA used as an eligibility criterion must be drawn within 42 days prior to injection number 1 and will be redrawn on Day 1 for use as a baseline value.

You may not qualify if:

• Candidates for salvage radiation therapy unless the patient refuses.
• Active or unresolved clinically significant infection.
• Parenteral antibiotics \<7 days prior to initiation of treatment.
• Evidence of prior or current CNS metastases. Specific imaging is not necessary in the absence of signs or symptoms.
• Co-morbid medical conditions which would result in a life expectancy (participation) of less than 1 year.
• Patients with compromised immune systems; congenital, acquired, or drug-induced (immunosuppressive agents) will be excluded from the study. Use of prednisone at doses higher than 10 mg daily (or equipotent steroid doses) for more than 7 days within the last 3 months is not allowed.
• No-pre-existing malignancies that required treatment within the past 5 years except for basal or squamous cell cancers of the skin.
• Prior systemic therapies for prostate cancer not allowed (hormonal therapy, including but not limited to LHRH agonists, antiandrogens, ketoconazole or chemotherapy - mitoxantrone/taxanes/estramustine, etc.) except when patients stopped hormone therapy two or more years prior to enrollment and currently have normal testosterone levels; patients in Arm B, undergoing androgen depletion therapy during the vaccination will be eligible.
• Prior participation in any vaccine studies for non-infectious diseases.
• The inability to understand the language and the clinical protocol.
• Allergy or religious objection to pork products; Gelfoam is produced from pork.

Sponsors & Collaborators

• David M Lubaroff: lead
• United States Department of Defense: collaborator

Study Sites (1)

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

• Elzey BD, Siemens DR, Ratliff TL, Lubaroff DM. Immunization with type 5 adenovirus recombinant for a tumor antigen in combination with recombinant canarypox virus (ALVAC) cytokine gene delivery induces destruction of established prostate tumors. Int J Cancer. 2001 Dec 15;94(6):842-9. doi: 10.1002/ijc.1556.

  PMID: 11745487 BACKGROUND

• Lubaroff DM, Konety B, Link BK, Ratliff TL, Madsen T, Shannon M, Ecklund D, Williams RD. Clinical protocol: phase I study of an adenovirus/prostate-specific antigen vaccine in men with metastatic prostate cancer. Hum Gene Ther. 2006 Feb;17(2):220-9. doi: 10.1089/hum.2006.17.220. No abstract available.

  PMID: 16454655 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: David Lubaroff, MD
• Organization: University of Iowa, Holden Comprehensive Cancer Center

david-lubaroff@uiowa.edu

3193561527

Study Officials

• David M Lubaroff, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: December 1, 2007
• Primary Completion: December 31, 2020
• Study Completion: January 31, 2023
• Last Updated: May 18, 2023
• Results First Posted: May 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)