This study is NOT currently recruiting participants.
Number
11-C-0247
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male Min Age: 18 Max Age: 100
Referral Letter Required
No
Population Exclusion(s)
Female;Children
Keywords
Androgen Deprivation Therapy; Vaccine; MUC-1-specific; Endorectal MRI; Immunologic Response
Recruitment Keyword(s)
Prostate Cancer
Condition(s)
Prostate Cancer; Neoplasms, Prostate; Neoplasms, Prostatic; Prostate Neoplasms
Investigational Drug(s)
Tecemotide
Investigational Device(s)
None
Intervention(s)
Biological/Vaccine: Tecemotide Drug: Cyclophosphamide Drug: Goserline Acetate Radiation: Radiation therapy
Supporting Site
National Cancer Institute
- Standard treatment for high-risk prostate cancer is hormone therapy and radiation therapy. The hormone therapy, called ADT, is an injection given once every 3 months. The radiation therapy uses high-energy radiation to kill the cancer cells and shrink the tumor. It is given 5 days a week for several weeks. Studies suggest that this treatment may be improved by adding a vaccine.
- The vaccine, tecemotide, may help the immune system fight the tumor. Tecemotide has been given to people with lung cancer and prostate cancer, and appears to have some benefits. More research is needed to determine if tecemotide can improve standard treatments for high-risk prostate cancer.
Objectives:
- To test the tecemotide vaccine combined with standard hormone and radiation therapy for high-risk prostate cancer.
Eligibility:
- Men at least 18 years of age who have high-risk prostate cancer and have not yet received treatment.
- The cancer must not have tumors outside the area of the prostate.
Design:
- Participants will be screened with a physical exam and medical history. They will also have blood tests and imaging studies.
- Participants will be in either the standard care group or the standard care plus tecemotide group.
- All participants will receive standard hormone and radiation therapy.
- Those who receive tecemotide will have chemotherapy 3 days before the first vaccine. The tecemotide vaccine will be given in four separate injections. Participants will be monitored for allergic reactions. The vaccine will be repeated every 2 weeks for five doses. Maintenance doses will follow every 6 weeks for four doses.
- Participants will have regular physical exams, blood tests, and imaging studies. Optional tumor biopsies will be done before study treatment begins, just before radiation therapy (after 2 months), and after about 10 months.
--Back to Top--
INCLUSION CRITERIA: - Histopathological documentation of prostate cancer confirmed at the institution of study enrollment prior to starting this study. - Must have either newly diagnosed or previously untreated prostate cancer with intermediate risk or high risk features defined as: -- Gleason 8 and higher OR -- PSA > 20 at the time of diagnosis OR -- Seminal vesicle involvement OR -- Extra-capsular extension (T3 disease) OR -- N1 (regional) lymph nodes Intermediate Risk Features Suggesting benefit from adjuvant ADT: Gleason score 7 OR, PSA >10 but <=20 ng/mL, OR Clnical tumor category 2b or 2c. - No evidence of metastatic disease on CT/MRI or bone scans - ECOG performance status of 0-1 - No systemic steroid use within 2 weeks prior to initiation of experimental therapy. Limited doses of systemic steroids to prevent IV contrast, allergic reaction or anaphylaxis (in patients who have known contrast allergies) are allowed. - Patients must be HLA-A2 or A3 positive for immunologic monitoring. - Hematological eligibility parameters -- Granulocyte count greater than or equal to1,500/mm(3) -- Platelet count greater than or equal to 150,000/mm(3) -- Hemoglobin greater than or equal to 9 g/dL - Biochemical eligibility parameters (within 16 days of starting therapy) - Baseline renal function: a) Serum creatinine less than or equal to 1.5 times the upper limit of normal OR creatinine clearance on a 24-h urine collection of greater than or equal to 60 mL/min. - Hepatic function: a) Total bilirubin less than or equal to 1.5 mg/dl, in patients with Gilberts syndrome, a total bilirubin less than or equal to 3.0 mg/dL b) AST and ALT less than or equal to 3 times upper limit of normal - No other active malignancies within the past 3 years (with the exception of non-melanoma skin cancers or carcinoma in situ of the bladder). - Willing to travel to the study centerfor follow-up visits - Age greater than or equal to 18 years old Able to understand and sign informed consent. - Must agree to use effective birth control (such as a condom) or abstinence during and for a period of 4 months after the last vaccination therapy. EXCLUSION CRITERIA: - Patients should have no evidence of being immunocompromised as listed below: -- Human immunodeficiency virus positivity due to the potential for decreased tolerance and may be at risk for severe side effects -- A medical condition requiring systemic steroids. (Nasal, topical, or inhaled steroid use is permitted.) Limited doses of systemic steroids to prevent IV contrast, allergic reaction, or anaphylaxis (in patients who have known contrast allergies) are allowed. -- A medical condition requiring immunosuppressive therapy, including allogeneic peripheral stem cell transplantation or solid organ transplantation -- Splenectomy - Patients who test positive for active Hepatitis B or Hepatitis C infection - Patients should have no autoimmune diseases that have required treatment such as: Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematous, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome and active Grave's disease. - History of immunodeficiency diseases (cellular immunodeficiencies, hypogammaglobulinaemia, dysgammaglobulinaemia) and in patients who have either hereditary or congenital immunodeficiencies. - 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, liver disease, inflammatory bowel disease, Crohn's disease, ulcerative colitis, active diverticulitis or ongoing or active infection. - Clinically significant cardiac disease, e.g. New York Heart Association (NYHA) classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months as confirmed by an electrocardiogram (ECG). -Patients who have received any prior therapy for prostate cancer (surgery, radiation, androgen deprivation therapy (GnRH agonist/antagonist) and/or chemotherapy); previous treatment with an androgen receptor antagonist is allowed; patients who have undergone orchiectomy are not eligible for this protocol. - Patients who have known brain metastasis, or with a history of seizures, encephalitis, or multiple sclerosis. -Patients receiving any other investigational agents or herbal medication -Contraindication to biopsy: -- Bleeding disorders -- PT/PTT greater than or equal to 1.5 times the upper limit of normal -- Artificial heart valve - Contraindication to MRI: -- Patients weighing >136 kilograms (weight limit for the scanner tables) -- Allergy to MR contrast agent -- Patients with pacemakers, cerebral aneurysm clips, shrapnel injury orimplantable electronic devices - Contraindication to radiation therapy: -- Pre-existing and active prostatitis or proctitis -- Inflammatory bowel disease or known genetic sensitivity to ionizing radiationsuch as ataxia telangiectasia. -- History of prior radiation to the pelvis - Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy.
- Histopathological documentation of prostate cancer confirmed at the institution of study enrollment prior to starting this study.
- Must have either newly diagnosed or previously untreated prostate cancer with intermediate risk or high risk features defined as:
-- Gleason 8 and higher OR
-- PSA > 20 at the time of diagnosis OR
-- Seminal vesicle involvement OR
-- Extra-capsular extension (T3 disease) OR
-- N1 (regional) lymph nodes
Intermediate Risk Features Suggesting benefit from adjuvant ADT: Gleason score 7 OR, PSA >10 but <=20 ng/mL, OR Clnical tumor category 2b or 2c.
- No evidence of metastatic disease on CT/MRI or bone scans
- ECOG performance status of 0-1
- No systemic steroid use within 2 weeks prior to initiation of experimental therapy. Limited doses of systemic steroids to prevent IV contrast, allergic reaction or anaphylaxis (in patients who have known contrast allergies) are allowed.
- Patients must be HLA-A2 or A3 positive for immunologic monitoring.
- Hematological eligibility parameters
-- Granulocyte count greater than or equal to1,500/mm(3)
-- Platelet count greater than or equal to 150,000/mm(3)
-- Hemoglobin greater than or equal to 9 g/dL
- Biochemical eligibility parameters (within 16 days of starting therapy)
- Baseline renal function:
a) Serum creatinine less than or equal to 1.5 times the upper limit of normal OR creatinine clearance on a 24-h urine collection of greater than or equal to 60 mL/min.
- Hepatic function:
a) Total bilirubin less than or equal to 1.5 mg/dl, in patients with Gilberts syndrome, a total bilirubin less than or equal to 3.0 mg/dL
b) AST and ALT less than or equal to 3 times upper limit of normal
- No other active malignancies within the past 3 years (with the exception of non-melanoma skin cancers or carcinoma in situ of the bladder).
- Willing to travel to the study centerfor follow-up visits
- Age greater than or equal to 18 years old Able to understand and sign informed consent.
- Must agree to use effective birth control (such as a condom) or abstinence during and for a period of 4 months after the last vaccination therapy.
EXCLUSION CRITERIA:
- Patients should have no evidence of being immunocompromised as listed below:
-- Human immunodeficiency virus positivity due to the potential for decreased tolerance and may be at risk for severe side effects
-- A medical condition requiring systemic steroids. (Nasal, topical, or inhaled steroid use is permitted.) Limited doses of systemic steroids to prevent IV contrast, allergic reaction, or anaphylaxis (in patients who have known contrast allergies) are allowed.
-- A medical condition requiring immunosuppressive therapy, including allogeneic peripheral stem cell transplantation or solid organ transplantation
-- Splenectomy
- Patients who test positive for active Hepatitis B or Hepatitis C infection
- Patients should have no autoimmune diseases that have required treatment such as: Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematous, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome and active Grave's disease.
- History of immunodeficiency diseases (cellular immunodeficiencies, hypogammaglobulinaemia, dysgammaglobulinaemia) and in patients who have either hereditary or congenital immunodeficiencies.
- 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, liver disease, inflammatory bowel disease, Crohn's disease, ulcerative colitis, active diverticulitis or ongoing or active infection.
- Clinically significant cardiac disease, e.g. New York Heart Association (NYHA) classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months as confirmed by an electrocardiogram (ECG).
-Patients who have received any prior therapy for prostate cancer (surgery, radiation, androgen deprivation therapy (GnRH agonist/antagonist) and/or chemotherapy); previous treatment with an androgen receptor antagonist is allowed; patients who have undergone orchiectomy are not eligible for this protocol.
- Patients who have known brain metastasis, or with a history of seizures, encephalitis, or multiple sclerosis.
-Patients receiving any other investigational agents or herbal medication
-Contraindication to biopsy:
-- Bleeding disorders
-- PT/PTT greater than or equal to 1.5 times the upper limit of normal
-- Artificial heart valve
- Contraindication to MRI:
-- Patients weighing >136 kilograms (weight limit for the scanner tables)
-- Allergy to MR contrast agent
-- Patients with pacemakers, cerebral aneurysm clips, shrapnel injury orimplantable electronic devices
- Contraindication to radiation therapy:
-- Pre-existing and active prostatitis or proctitis
-- Inflammatory bowel disease or known genetic sensitivity to ionizing radiationsuch as ataxia telangiectasia.
-- History of prior radiation to the pelvis
- Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy.
Principal Investigator
Referral Contact
For more information: