NIH Clinical Research Studies

Protocol Number: 07-C-0188

Active Accrual, Protocols Recruiting New Patients

Title:
A Double-Blind Randomized Phase 2.5 Trial of ONY-P1 Vaccine Versus Placebo in Men with D0 Prostate Cancer Following Limited Androgen Ablation
Number:
07-C-0188
Summary:
Background:

-New treatment options are needed for patients with prostate cancer whose prostate-specific antigen (PSA) levels rise after surgery or radiation therapy.

-Onyvax is an experimental vaccine designed to help the immune system recognize and attack cancer cells.

-Hormonal therapy with the drug goserelin stops testosterone production in the body. This treatment can kill prostate tumor cells and lower PSA levels, and may help increase immune responses to Onyvax vaccine.

Objectives:

-To determine the safety and effectiveness of Onyvax vaccine therapy following hormonal therapy in patients with prostate cancer.

-To determine if treatment with Onyvax vaccine following hormonal therapy can delay a rise in PSA.

Eligibility:

-Men with a rising PSA level following localized surgery or radiation therapy for prostate cancer.

-Normal testosterone level.

-No evidence of disease on CT or bone scan.

Design:

-Patients are treated with hormone therapy (goserelin) for 3 months. Following hormonal therapy, patients are randomly assigned to receive either Onyvax vaccine or placebo vaccine. Vaccines are given as an injection on days 1, 15, and 29, and then every 4 weeks for up to 52 weeks.

-Before treatment begins, patients have a medical history and physical examination, blood and urine tests, a bone scan, and a CT scan of the pelvis and abdomen. Physical examination and blood and urine tests are repeated before each injection and at the end of the study.

-Patients who have the HLA-A2 tissue type undergo apheresis, a process for obtaining white cells. Whole blood is collected through a tube (similar to donating blood) and flows through a cell-separator machine. The white cells are extracted for immune studies and the rest of the blood (platelets, red cells, and plasma) is returned to the body.

Sponsoring Institute:
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male
Referral Letter Required: No
Population Exclusion(s): Children

Female

Eligibility Criteria:
INCLUSION CRITERIA:

A. Histopathological documentation of prostate cancer confirmed in the Laboratory of Pathology at the National Institutes of Health (NIH) Clinical Center, the National Naval Medical Center, or Walter Reed Army Medical Center prior to enrollment. If no pathologic specimen is available, patients may enroll with a pathologist's report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease.

B. Biochemical progression defined as follows:

-For patients following definitive radiation therapy or cryotherapy: a rise in PSA of greater than or equal to 2 ng/mL above the nadir (per RTOG-ASTRO consensus criteria).

-For patients following radical prostatectomy: 2 consecutive rises in PSA greater than 0.3 ng/mL (per NCCN guidelines).

-Patients will be eligible to participate following definitive therapy when they meet the criteria for biochemical progression described in Section 2.1.1B. On average, this will be 2-3 years after definitive therapy.

C. Life expectancy greater than or equal to 6 months.

D. ECOG performance status of 0-1.

E. Recovery from acute toxicity related to prior therapy, including surgery and radiation, or no toxicity greater than or equal to grade 2.

F. Hematological eligibility parameters (within 16 days of starting therapy):

-Granulocyte count greater than or equal to 1500/mm(3)

-Platelet count greater than or equal to 100 000/mm(3)

-Hgb greater than or equal to 10 g/dL

G. Biochemical eligibility parameters (within 16 days of starting therapy):

-Hepatic function: bilirubin less than or equal to 1.5 mg/dL (OR in patients with Gilbert's syndrome, a total bilirubin less than or equal to 3.0), AST and ALT less than or equal to 2.5 times upper limit of normal.

H. No other active malignancies within the past 60 months (with the exception of nonmelanoma skin cancers or carcinoma in situ of the bladder) or life-threatening illnesses.

I. Willing to travel to the NIH for follow-up visits.

J. 18 years of age or older.

K. Able to understand and sign informed consent.

L. Baseline testosterone greater than or equal to lower limit of normal.

M. PSA less than or equal to 20 ng/mL.

N. Negative CT scan and bone scan for metastatic prostate cancer.

EXCLUSION CRITERIA:

A. Immunocompromised status due to:

-Human immunodeficiency virus (HIV) positivity.

-Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren 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, and GI tract will be allowed.

-Other immunodeficiency diseases or iatrogenic immunodeficiency from drugs.

-Concurrent use of topical steroids (including steroid eye drops) or systemic steroids. Nasal or inhaled steroid use is permitted.

B. Serious intercurrent medical illness that would interfere with patient's ability to carry out the treatment program.

C. Prior chemotherapy.

D. Clinically active brain metastasis.

E. Documented contraindication (allergy or severe reaction to BCG).

F. Other active autoimmune diseases such as, Addison's disease, Hashimoto's thyroiditis, or systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome active Grave's disease.

G. Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (eg phytoestrogens and saw palmetto).

Special Instructions:
Currently Not Provided
Keywords:
Biochemical Failure
Combination Therapy
Immunotherapy
PSA Progression
Whole Tumor Cell Vaccine
Recruitment Keyword(s):
Prostate Cancer
Condition(s):
Prostate Cancer
Investigational Drug(s):
ONY-PI Whole Tumor Cell Vaccine
Investigational Device(s):
None
Intervention(s):
Drug: ONY-PI Whole Tumor Cell Vaccine
Supporting Site:
National Cancer Institute

Contact(s):
NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):
Jemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ. Cancer statistics, 2006.CA Cancer J Clin. 2006 Mar-Apr;56(2):106-30.

Dillioglugil O, Leibman BD, Kattan MW, Seale-Hawkins C, Wheeler TM, Scardino PT. Hazard rates for progression after radical prostatectomy for clinically localized prostate cancer. Urology. 1997 Jul;50(1):93-9.

Stamey TA, Yemoto CM, McNeal JE, Sigal BM, Johnstone IM. Prostate cancer is highly predictable: a prognostic equation based on all morphological variables in radical prostatectomy specimens. J Urol. 2000 Apr;163(4):1155-60.

Active Accrual, Protocols Recruiting New Patients

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