153Sm-EDTMP With or Without a PSA/TRICOM Vaccine To Treat Men With Androgen-Insensitive Prostate Cancer

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

Background: * No treatment is known to improve survival for prostate cancer patients who have not been helped by previous treatments with hormones and chemotherapy. * An experimental vaccine called prostate specific antigen (PSA)/TRICOM contains genes for a protein produced by prostate cancer cells called prostate-specific antigen (PSA). The vaccine can trigger the immune system to make cells that may be able to recognize and attack the cancer cells that make PSA. * Granulocyte macrophage colony stimulating factor (GM-CSF) is an approved drug that is usually given to increase a patient's white blood cell count or to stimulate the immune system. * 1Samarium-153-ethylene diamine tetramethylene phosphonate (53Sm-EDTMP) is a radioactive drug that has been approved for many years to treat advanced prostate cancer. It is given through a vein and can be targeted directly to tumors in the bone where it can relieve pain caused by bone lesions. Radiation also increases the level of certain proteins inside the tumor, making it easier for the immune system to find and kill the tumor cells. * When laboratory mice were given just vaccine, just radiation, or a combination of both, the combination was most effective in treating tumors. Objectives: -To determine if combined treatment with PSA/TRICOM vaccine and 153Sm-EDTMP radiation can delay progression of prostate cancer better than radiation alone. Eligibility: -Patients who have advanced prostate cancer that has worsened despite treatments with hormones, have two or more bone lesions related to their prostate cancer, and have had prior treatment with docetaxel chemotherapy. Design: * Patients are randomly assigned to receive radiation alone (Arm A) or radiation with vaccine and sargramostim (Arm B). * Arm A receives 153Sm-EDTMP radiation starting on study day 8 and repeated every 12 weeks. * Arm B receives a priming vaccine on study day 1 and radiation on day 8. Radiation therapy is repeated every 12 weeks. Boosting vaccines are given on days 15 and 29 and then monthly. GM-CSF is given with each vaccination (on the day of the vaccination and for the next 3 days) to enhance the immune response. Vaccinations and GM-CSF are given as injections under the skin, usually in the thigh. Radiation therapy is given through a vein. * Patients are monitored regularly with physical examinations, blood and urine tests, and scans to evaluate safety and treatment response. * Patients who are human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2)-positive undergo apheresis, a procedure similar to donating blood, for obtaining immune cells called lymphocytes to measure the immune response to the vaccine.

Key facts

Study ID

NCT00450619

Run by

National Cancer Institute (NCI)

People needed

44

Starts

2007-02-01

Expected to finish

2012-11-01

Last updated by the study team

2017-01-04

Who can join

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

You may not qualify if…

• A. Patients should have no evidence, as listed below, of being immunocompromised:
• Human immunodeficiency virus (HIV) positivity due to the potential for decreased tolerance and risk for severe side effects.
• Hepatitis B or C positivity.
• Concurrent use of topical steroids (including steroid eye drops) or systemic steroids. This is to avoid immunosuppression which may lead to potential complications with vaccinia (priming vaccination). Nasal or inhaled steroid use is permitted.
• B. Patients should have no autoimmune diseases that have required treatment, such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren's syndrome, scleroderma, myasthenia gravis, Goodpasture's 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 central nervous system (CNS), heart, lungs, kidneys, skin, and gastrointestinal tract (GI) tract, will be allowed.
• C. History of allergy or untoward reaction to prior vaccination with vaccinia virus or to any component of the vaccinia vaccine regimen. Note: prior vaccination with vaccinia is not required.
• D. Do not administer the recombinant vaccinia vaccine if the recipient or, for at least 3 weeks after vaccination, their close household contacts (close household contacts are those who share housing or have close physical contact), are 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 3 years of age and under; and immunodeficient or immunosuppressed persons (by disease or therapy), including HIV infection.
• E. Serious intercurrent medical illness (e.g., one that requires treatment) which would interfere with the ability of the patient to carry out the treatment program, including, but not limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis.
• F. Patients with a history of cardiomyopathy or symptomatic congestive heart failure (unless stable on treatment), symptomatic arrhythmia not controlled by medication. Unstable atherosclerotic heart disease (e.g. unstable angina) who require active intervention and history of myocardial infarction or embolic stroke within the past 6 months.
• G. Patients with cardiac disease who have fatigue, palpitation, dyspnea or angina with ordinary physical activity (New York Heart Association class 2 or greater) are not eligible.
• H. Patients with a history of congestive heart failure or who have objective evidence of congestive heart failure by physical exam or imaging are not eligible, unless the underlying cause has been treated and patient has documented normal ejection fraction.
• I. Patients with pulmonary disease who have fatigue or dyspnea with ordinary physical activity are not eligible.
• J. Concurrent chemotherapy.
• K. No brain metastasis or history of seizures, encephalitis, or multiple sclerosis.
• L. Serious hypersensitivity reaction to egg products.
• M. Prior splenectomy.
• N. Contraindicated in patients who have known hypersensitivity to EDTMP or similar phosphonate compounds.
• O. Patients with symptomatic soft tissue disease or parenchymal disease will be excluded.
• P. Radiation therapy to bone within 4 weeks of study entry.
• Q. Patients previously treated with (153)Sm-EDTMP will be excluded.
• R. Patients requiring urgent local radiotherapy or orthopedic stabilization.

Where it is running

• University of Chicago — Chicago, Illinois, United States
• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
• Cancer Institute of New Jersey — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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