Sequential Vaccinations in Prostate Cancer Patients

Completed · Phase 1/Phase 2

Conditions studied: Prostatic Neoplasms

In brief

Background: " Adenocarcinoma of the prostate is the most common cancer diagnosis in American males and follows lung cancer as the leading cause of cancer death. " Vaccine strategies represent a novel therapeutic approach in the treatment for prostate cancer. One potential target for a prostate cancer vaccine is prostatic specific antigen (PSA), due to its restricted expression on prostate cancer and normal prostatic epithelial cells. Objectives: " The primary objective is to determine the impact of granulocyte-macrophage colony stimulating factor (GM-CSF) and recombinant fowlpox granulocyte-macrophage colony stimulating factor (rF-GM-CSF) on the immunologic response in patients treated with these vaccines. " Secondary - to determine the change in prostatic specific antigen (PSA)-specific T cells in patients treated with these vaccines using enzyme linked immunosorbent spot (ELISPOT) assay analysis. " To document any objective anti-tumor responses that may occur. Eligibility: " Patients must have androgen insensitive metastatic prostate cancer. " All patients will have received and progressed on hormonal therapy. " Must have objective evidence of metastasis or relapsing local disease. Therefore, must have a rising PSA and at least one of the following: positive bone scan, palpable disease, or positive imaging studies. " Must have a life expectancy of more than 6 months and Eastern Cooperative Oncology Group (ECOG) status of 0 to 2. "Patients must be human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2+). " Granulocyte count greater than or equal to 1,500/mm\^3, Platelet greater than or equal to 100,000/mm\^3, hemoglobin (Hgb) greater than or equal to 10Gm/dL, Lymphocyte count greater than or equal to 500/mm\^3 ;Bilirubin less than 1.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5x upper limit of normal (ULN),Creatinine Clearance greater than or equal to 60 " No significant cardiac disease, no significant pulmonary disease, no serious inter-current medical illness. Design: " Cohorts three, four and five will provide safety data combining cohort two with rGM-CSF as well as two doses of rFGM-CSF respectively. "This study will be conducted as a small, randomized pilot study to compare the immunologic effects of the above vaccine strategy alone, with recombinant granulocyte-macrophage colony stimulating factor (GM-CSF), or with either of 2 doses of fowlpox-GM-CSF. "This study will consist of 4 randomized arms of 8 patients each, all of whom are HLA-A2+. The maximum accrual to the trial should be 62.

Key facts

Study ID: NCT00060528
Run by: National Cancer Institute (NCI)
People needed: 32
Starts: 2003-05-22
Expected to finish: 2009-06-08
Last updated by the study team: 2017-10-26

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histopathological documentation of prostate cancer confirmed in the Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI), or National Naval Medical Center (NNMC) prior to starting this study. If no pathologic specimen is available to the NCI or NNMC, patients may enroll with a pathologist's report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease.
All patients will have received and progressed on hormonal therapy for metastatic prostate carcinoma.
All subjects must have objective evidence of metastasis or relapsing local disease to be eligible; therefore, they must have a rising PSA and at least one of the following: positive bone scan, palpable disease, or positive imaging studies, as defined below.
i. Two consecutively rising PSA levels, separated by at least 1 week, with at least one measurement that is 50% above the
nadir reached after the last therapeutic maneuver (as long as the last measurement is 5 ng/ml or greater), and
ii. At least one lesion consistent with metastatic cancer on Technetium (Tc)-99 whole body scintigraphy, and/or
iii. Soft-tissue metastases as measured by appropriate modalities (i.e., imaging, palpation).
Patients must have a life expectancy of more than 6 months.
Patients must have a performance status of 0 to 2 according to the ECOG criteria.
Patients must have recovered from any acute toxicity related to prior therapy, including surgery, and radiation (treatment must have been completed at least 4 weeks prior to being eligible for the study).
Hematological eligibility parameters (within 16 days of starting therapy):
Granulocyte count greater than or equal to 1,500/mm\^3
Platelet count greater than or equal to 100,000/mm\^3
Lymphocyte count greater than or equal to 500/mm\^3
Hgb greater than or equal to 10 Gm/dL
Biochemical eligibility parameters (within 16 days of starting therapy):
A 24-hour urine collection for baseline to measure creatinine clearance (CrCl), protein and electrolytes.
CrCl greater than 60
proteinuria less than 1000 milligrams per 24 hours, less than or equal to Grade 1 (NCI-Common Toxicity Criteria (CTC) version 2.0) proteinuria, Grade 0 hematuria, and no abnormal sediment.
Grade 0 creatinine.
Patients must have serum creatinine within normal limits.
Any abnormalities in the sediment or the presence of hematuria without a likely underlying cause should prompt the investigator to consider an evaluation by a nephrologist for evidence of underlying renal pathology. Patients may be eligible if the underlying cause of the abnormality is determined to be non-renal.
Hepatic function: Bilirubin less than 1.5 mg/dl,
AST and ALT less than 2.5 times upper limit of normal.
Patients must test negative for HIV, Hepatitis B and C.

You may not qualify if…

Prior splenectomy.
Concurrent steroid use, except topical steroids or inhaled steroid use.
The recombinant vaccinia vaccine should not be administered if the following apply to either recipients or, for at least 3 weeks after vaccination, their close household contacts:
persons with active or a history of eczema or other eczematoid skin disorders; those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne or other open rashes or wounds) until condition resolves; pregnant or nursing women; children under 5 years of age; and immunodeficient or immunosuppressed persons (by disease or therapy), including HIV infection.
Close household contacts are those who share housing or have close physical contact.
Patients with known allergy to eggs.
Other serious intercurrent illness.
Patients with brain metastases.
Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment) or New York Heart Association class II-IV congestive heart failure.
Patients on antiandrogen therapy must undergo antiandrogen withdrawal for at least 4 weeks and still show evidence of a rising PSA.
Following treatment with bicalutamide, patients must undergo withdrawal for at least 6 weeks and still show evidence of a rising PSA.
Prior treatments with vaccine expressing PSA are NOT eligible.
Patients with significant autoimmune disease that is active or potentially life threatening if activated.
Patients with clinically significant cardiomyopathy requiring treatment should be excluded from protocol eligibility at this time.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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