PSA-Based Vaccine and Radiotherapy to Treat Localized Prostate Cancer
Completed · Phase 2
Conditions studied: Prostate Cancer, Prostate Neoplasm
In brief
This study will test the ability of an experimental vaccine to increase the number of tumor-fighting immune cells (lymphocytes) in patients with localized prostate cancer and prevent the disease from recurring following radiation therapy. The vaccine is intended to stimulate lymphocytes to target and attack cells containing a protein called prostate specific antigen, or PSA. It is composed of the following parts: * rV-PSA: Vaccinia virus plus human DNA that produces PSA (prostate specific antigen) * rV-B7.1: Vaccinia virus plus human DNA that produces B7.1 (a protein that helps guide immune cells to their targets) * rF-PSA: Fowlpox virus plus human DNA that produces PSA * GM-CSF: Drug that boosts the immune system. * IL-2: Drug that boosts the immune system. Patients 18 years of age and older with prostate cancer confined to the prostate who have received a smallpox vaccine sometime in the past and who do not have a history of allergy to eggs may be eligible for this study. Candidates are screened with a complete medical history and physical examination, blood tests, and skin tests (similar to those for allergies or tuberculosis) to assess immune function. Participants are randomly assigned to receive one of the following three treatments: Group 1 - standard radiation therapy plus the experimental vaccine; Group 2 - standard radiation therapy without the vaccine; Group 3 - standard radiation therapy with the vaccine, but with a different dose of IL-2 from Group 1. Patients in the vaccine groups receive injections in the arm or thigh in 28-day treatment cycles, as follows: * GM-CSF: Days 1 through 4 of the first week * IL-2 5: for Group 1, 5 days in the second week of each cycle; for Group 3, 14 days beginning in the second week of each cycle * rV-PSA and rV-B7.1: Day 2 of the first cycle only * rF-PSA (booster shots): Every 28 days, beginning day 2 of the second cycle (i.e., days 30, 58, 86, etc.) Treatment continues for eight cycles unless serious side effects develop, PSA levels rise significantly, or the doctors feel there is no reason to continue therapy. All patients undergo radiation therapy and possibly hormone therapy, if indicated. Blood samples are drawn once a week for the first month and then once every 4 weeks to monitor safety. After treatment ends, patients are followed with examinations and blood tests every 3 months for the first 2 years and then every 6 months until the doctors determine follow-up is no longer needed or the cancer returns. All patients have HLA tissue typing at the beginning of the study. Those who are type HLA-A2 are asked to have additional procedures for studying the immune response that can be done only with this tissue type. This involves collecting blood samples before treatment begins, every 4 weeks during treatment, once after cycle 2, and once 4 months after the eighth vaccine. They also undergo four leukapheresis procedures for collecting white blood cells. For leukapheresis, blood is collected through a needle in an arm vein, similar to donating a unit of blood. The blood flows through a machine that separates it into its components. The white cells are removed, and the red cells, platelets and plasma are returned to the body, either through the same needle or through a needle in the other arm.
Key facts
- Study ID
- NCT00005916
- Run by
- National Cancer Institute (NCI)
- People needed
- 48
- Starts
- 2000-06-13
- Expected to finish
- 2005-12-22
- Last updated by the study team
- 2017-07-02
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may not qualify if…
- Patients should have no evidence of being immunocompromised as listed below:
- They should have no reactive HIV testing;
- They should not have any other diagnosis of altered immune function, autoimmune disease (autoimmune neutropenia, thrombocytopenia, or hemolytic anemia; systemic lupus erythematosus, Sjogren syndrome, or scleroderma; myasthenia gravis; Goodpasture syndrome; Addison's disease, Hashimoto's thyroiditis, or active Graves' disease).
- They should not have prior radiation therapy greater than 50% of nodal groups;
- They should not have had a prior splenectomy;
- They should not be using glucocorticoids (including glucocorticoids for brachytherapy).
- The recombinant vaccinia vaccine should not be administered if the following apply to either recipients or, for at least two 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 wound) 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.
- Other serious intercurrent illness. Patients with active infections requiring antibiotic treatment (including chronic suppressive therapy) are not eligible until the infection has cleared and the antibiotics have been stopped for at least three days.
- History of other malignant process (excluding squamous cell or basal cell carcinoma of the skin), unless that previous tumor was treated with curative intent and the patient has been in remission for at least three years.
- Patients with a history of seizures, encephalitis, or multiple sclerosis are not eligible.
- Patients with known allergy to eggs are not eligible.
- Patients should not have any cardiac disease, pulmonary disease, autoimmune disease, renal disease or hepatic dysfunction that may be exacerbated by IL-2.
Where it is running
- National Cancer Institute (NCI), 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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