Status:
WITHDRAWN
Human Telomerase Reverse Transcriptase Messenger RNA (hTERT mRNA) Transfected Dendritic Cell Vaccines
Lead Sponsor:
University of Florida
Conditions:
Metastatic Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this research is to develop a new and powerful type of immune therapy for prostate cancer patients. This therapy involves vaccinations with special stimulator cells found in the human b...
Detailed Description
Primary objectives of trial include to evaluate the safety and biologic efficacy of hTERT mRNA transfected dendritic cells (DC), applied in a prime-boost format, to stimulate hTERT-specific CD4+ and C...
Eligibility Criteria
Inclusion
- Subjects must have histologically or clinically confirmed adenocarcinoma of the prostate with either:
- metastatic prostate adenocarcinoma, Stage (T1-4, N+, M0) or (T1-4, N0-3, M+) OR
- two documented rising PSA levels while maintained on LHRH analogues.
- Subjects who are receiving nonsteroidal antiandrogen therapy must discontinue therapy for 4 weeks prior to study entry.
- Karnofsky Performance Status (KPS) greater than or equal to 80%
- Age ≥ 18 years
- Adequate hematologic function with:
- WBC ≥ 3000 mm3
- hemoglobin ≥ 9 mg/dl
- platelets ≥ 100,000/mm3
- • Adequate renal and hepatic function with:
- serum creatinine \< 2.5 mg/dl
- bilirubin \< 2.0 mg/dl
- • Adequate coagulation parameters with:
- Prothrombin Time \< 1.5 x control
- Partial thromboplastin time \< 1.5 x control • Ability to understand and provide signed inform consent that fulfills Institutional Review Board guidelines.
Exclusion
- Subjects who have received radiation therapy within 4 weeks of pretreatment evaluation. (There must be at least 12 weeks if prior therapy included 89-Strontium between any prior therapy and study entry.)
- Subjects who have received chemotherapy or biologic regimens within 4 weeks of pretreatment evaluation.
- Subjects who have received immunotherapy within 4 weeks of pretreatment evaluation.
- Subjects who have not recovered from radiation, chemotherapy, or immunotherapy toxicities.
- Subjects with either previously irradiated or new CNS (central nervous system) metastases. (Pre-enrollment head CT is not required.)
- Subjects with a history of autoimmune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
- Subjects with serious intercurrent chronic or acute illness such as pulmonary (asthma or COPD) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the P.I. to constitute an unwarranted high risk for investigational drug treatment.
- Medical or psychological impediment to probable compliance with the protocol.
- Concurrent second malignancy other than non-melanoma skin cancer, or controlled superficial bladder cancer. In the event of prior malignancies treated surgically, the subject must be considered NED (no evidence of disease) for a minimum of 3 years prior to enrollment.
- Presence of an active acute or chronic infection, including symptomatic urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot) or viral hepatitis (as determined by HBsAg and Hepatitis C serology).
- Subjects on steroid therapy (or other immunosuppressive agents such as azathioprine or cyclosporine A) are excluded on the basis of potential immune suppression. Subjects must have had 4 weeks of discontinuation of any steroid therapy prior to enrollment.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01153113
Start Date
January 1 2008
End Date
December 1 2010
Last Update
December 2 2011
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