Phase II Study of Adenovirus/PSA Vaccine in Men With Hormone - Refractory Prostate Cancer

NCT00583024 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 201705744PC061667/2200605710
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This investigational study involves treatment with an Ad/PSA vaccine for men with prostate cancer who present with evidence of hormone refractory metastatic disease.

Conditions

Hormone Refractory Prostate Cancer

Keywords

prostate cancer; vaccine; immunotherapy

Outcome Measures

Primary Outcomes (2)

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

  To evaluate the increase, decrease, or stable response rates (PSA responses and changes in PSADT) of the Ad/PSA vaccine using a prime-boost immunization strategy. PSADT will be calculated based on the MSKCC online calculator.

  18 months

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

  Strong or modest antibody responses to PSA measured by the binding to PSA-secreting cell lines

  18 months

Secondary Outcomes (1)

• Number of Participants Alive and Deceased Following Treatment

  Every 6 months, up to 14 years

Study Arms (1)

Adenovirus/PSA Vaccine

EXPERIMENTAL

Participants will receive three injections of 0.16 ml. (0.125 ml. vaccine + 0.035 ml. Gelfoam) of the Ad/PSA subcutaneously

Biological: ADENOVIRUS/PSA VACCINE

Interventions

ADENOVIRUS/PSA VACCINE BIOLOGICAL

1x10E8 pfu in Gelfoam subcutaneously on days 0, 30, 60

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 present with evidence of hormone refractory disease (D3).
• Men with a positive bone scan or a positive CT scan (with obvious soft tissue metastasis or lymph nodes \>1 cm), a PSA doubling time of \>/= 6 months, and a total PSA of \<10 ng/ml, and asymptomatic OR men with a negative bone scan and a negative CT scan with any PSA doubling time and asymptomatic.
• Scans must be obtained within 6 weeks of initiation of treatment.
• Written informed consent.
• Age \>/= 18 years.
• Required laboratory values (obtained within 2 weeks of 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 total bilirubin \<1.5 mg/dl (unless bilirubin elevation is consistent with Gilbert's syndrome).
• Castrate levels of testosterone of \</= 50 ng/ml.
• PSA can be used as an eligibility criterion must be drawn within 28 days prior to injection number 1 and will be drawn on Day 1 for use as a baseline value.

You may not qualify if:

• 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 3 months of initiation of treatment is not allowed.
• Pre-existing malignancies that required treatment within the past 5 years except for basal or squamous cell cancers of the skin.
• Prior participation in any vaccine studies for non-infectious diseases.
• Prior chemotherapy, defined as prior cytotoxic chemotherapy for prostate cancer (or any cancer unless more than 5 years have elapsed). Examples of cytotoxic chemotherapy are mitoxantrone/prednisone and taxanes. Drugs such as Casodex or ketoconazole treatment must have been completed at least 6 weeks prior to initiation of treatment.
• 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 (3)

• 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

• Cavacini LA, Duval M, Eder JP, Posner MR. Evidence of determinant spreading in the antibody responses to prostate cell surface antigens in patients immunized with prostate-specific antigen. Clin Cancer Res. 2002 Feb;8(2):368-73.

  PMID: 11839651 RESULT

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, PhD
• Organization: University of Iowa/Holden Comprehensive Cancer Center

david-lubaroff@uiowa.edu

(319) 335-8423

Study Officials

• David M Lubaroff, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• 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: April 28, 2023
• Results First Posted: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)