Vaccine Therapy in Treating Patients With Advanced Adenocarcinoma of the Prostate (Prostate Cancer)
Stopped early · Phase 2
Conditions studied: Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer
In brief
Randomized phase II trial to determine the effectiveness of vaccine therapy in treating patients who have advanced adenocarcinoma of the prostate (prostate cancer). Vaccines made from a person's prostate cancer cells may make the body build an immune response to kill tumor cells
Key facts
- Study ID
- NCT00005039
- Run by
- National Cancer Institute (NCI)
- People needed
- 86
- Starts
- 2000-01-01
- Last updated by the study team
- 2013-01-24
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Histologically proven adenocarcinoma of the prostate with evidence of metastatic disease including any of the following:
- Lymph node positive and prostate-specific antigen (PSA) at least 10 ng/mL
- Bone scan positive and PSA at least 10 ng/mL
- Prior radical prostatectomy with rising PSA and PSA at least 2 ng/mL
- Prior radiotherapy and PSA at least 10 ng/mL
- Prior cryosurgery and PSA at least 10 ng/mL
- PSA criteria does not apply to patients who are assigned to group B of this study and were previously treated on vaccine trial DFCI-96079
- No symptomatic metastatic disease (no bony pain)
- Complete HLA typing required
- Performance status - ECOG 0 or 1
- WBC greater than 2,000/mm\^3
- Platelet count greater than 100,000/mm\^3
- Bilirubin less than 2.0 mg/dL
- SGPT less than 4 times upper limit of normal
- Creatinine less than 4.0 mg/dL
- No altered immune function such as eczema
- No autoimmune diseases such as the following:
- Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia
- Systemic lupus erythematosus, Sjögren's syndrome, or scleroderma
- Myasthenia gravis
- Goodpasture's syndrome
- Addison's disease, Hashimoto's thyroiditis, or active Graves' disease
- HIV negative
- No allergy or untoward reaction to prior vaccinia (smallpox) vaccination
- No hypersensitivity to eggs
Where it is running
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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