Vaccine Therapy in Treating Patients With Stage D0 Prostate Cancer

NCT00514072 | Unknown Phase 2

• 3 other identifiers: CDR0000559937NCI-07-C-0188ONYVAX-ONY-P1-07-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This randomized phase II trial is studying vaccine therapy to see how well it works compared with a placebo in treating patients with stage D0 prostate cancer.

Conditions

Prostate Cancer

Keywords

stage IV prostate cancer; recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• Time to PSA progression

Secondary Outcomes (4)

• Toxicity

• Immunologic response as assessed by ELISPOT assay

• PSA kinetics (doubling time/velocity) of treatment

• Time to testosterone recovery

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive ONY-P1 vaccine with BCG intradermally on days 1 and 15. Patients then receive ONY-P1 vaccine alone on day 29 and then every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.

Biological: BCG vaccine; Biological: prostate cancer vaccine ONY-P1

Arm II

PLACEBO COMPARATOR

Patients receive placebo vaccine intradermally on days 1, 15, and 29 and then every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.

Other: placebo

Interventions

BCG vaccine BIOLOGICAL

given intradermally

Arm I

prostate cancer vaccine ONY-P1 BIOLOGICAL

given intradermally

Arm I

placebo OTHER

given intradermally

Arm II

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histopathological documentation of prostate cancer * If no pathologic specimen is available, patients may enroll on study with a pathologist's report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease * Biochemical progression, as defined by the following: * A rise in PSA of ≥ 2 ng/mL above the nadir (for patients previously treated with definitive radiotherapy or cryotherapy) * Two consecutive rises in PSA \> 0.3 ng/mL (for patients previously treated with radical prostatectomy) * PSA ≤ 20 ng/mL * Testosterone ≥ lower limit of normal * Negative CT scan and bone scan for metastatic prostate cancer * No clinically active brain metastases PATIENT CHARACTERISTICS: * ECOG performance status of 0-1 * Life expectancy ≥ 6 months * Granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10 g/dL * Bilirubin ≤ 1.5 mg/dL OR total bilirubin ≤ 3.0 mg/dL (in patients with Gilbert's syndrome) * AST and ALT ≤ 2.5 times upper limit of normal * No other active malignancies within the past 60 months (with the exception of nonmelanoma skin cancer or carcinoma in situ of the bladder) * No life-threatening illnesses * No immunocompromised status due to any of the following: * HIV positivity * Active autoimmune diseases, such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjögren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome, or active Grave's disease * Patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function, including CNS, heart, lungs, kidneys, skin, or gastrointestinal tract, will be allowed * Other immunodeficiency diseases or iatrogenic immunodeficiency from drugs * No other serious medical illness that would interfere with the patient's ability to carry out the treatment program * No documented contraindication (allergy or severe reaction to BCG) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from all prior therapy, including surgery and radiotherapy (no toxicity ≥ grade 2) * No prior chemotherapy * No concurrent topical steroids (including steroid eye drops) or systemic steroids * Nasal or inhaled steroid use is permitted * No concurrent medications used for urinary symptoms, including 5-alpha reductase inhibitors (finasteride and dutasteride) * No concurrent alternative medications known to alter PSA (e.g., phytoestrogens or saw palmetto) * No other concurrent hormonal therapy * No other concurrent anticancer treatment, including chemotherapy, systemic glucocorticoids, radiotherapy, major surgical procedures for prostate cancer, or nonprotocol-related immunotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Kael-GemVax Co., Ltd.: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (2)

• Aragon-Ching JB, Williams KM, Gulley JL. Impact of androgen-deprivation therapy on the immune system: implications for combination therapy of prostate cancer. Front Biosci. 2007 Sep 1;12:4957-71. doi: 10.2741/2441.

  PMID: 17569623 BACKGROUND

• Huang J, Jochems C, Talaie T, Anderson A, Jales A, Tsang KY, Madan RA, Gulley JL, Schlom J. Elevated serum soluble CD40 ligand in cancer patients may play an immunosuppressive role. Blood. 2012 Oct 11;120(15):3030-8. doi: 10.1182/blood-2012-05-427799. Epub 2012 Aug 28.

  PMID: 22932804 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

BCG Vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• James L. Gulley, MD, PhD, FACP

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 9, 2007
• Study Start: March 1, 2007
• Primary Completion: September 1, 2012
• Last Updated: August 9, 2012

Record last verified: 2012-08

Locations

US (1)