Status:
COMPLETED
Safety and Effectiveness of a Vaccine for Prostate Cancer That Uses Each Patients' Own Immune Cells.
Lead Sponsor:
Rockefeller University
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to assess the safety and activity of a type of vaccine as immune therapy for prostate cancer. This vaccine will be made for each participant's own immune cells (called den...
Detailed Description
This is a Phase I/II dendritic cell vaccine study for patients with prostate cancer. Our laboratory has demonstrated that effective tumor immunity in humans is associated with, and likely mediated at ...
Eligibility Criteria
Inclusion
- Disease Characteristics
- Histologically confirmed prostate carcinoma
- Progressive, disease required, i.e.: elevated PSA documented to be rising on 3 occasions, either despite castrate testosterone levels (below 50 ng/dl), or after definitive local therapy (prostatectomy or radiation).
- Prior/Concurrent Therapy
- Biologic therapy:
- Recovered from toxicity of any prior therapy
- Chemotherapy:
- At least 4 weeks since chemotherapy -Endocrine evaluation/therapy
- 3 rising PSA values at least 2 weeks apart
- At least 2 weeks since concurrent corticosteroids (other than for replacement therapy for adrenal insufficiency)
- Medical hormonal therapy to maintain castrate testosterone levels permitted
- Radiotherapy:
- At least 4 weeks since radiotherapy
- Surgery:
- Prior surgery allowed
- Patient Characteristics
- Age: 18 and over, able to give written informed consent. Individuals unable to provide informed consent must have consent provided by the legal guardian, or person designated by the subject to give consent on his behalf.
- Performance status: Karnofsky 70-100%
- Life expectancy: At least 1 year
- Hematopoietic: obtained twice, once within 45 days prior to study entry, and again within 72 hours of study entry.
- WBC greater than 3,800
- Absolute neutrophils greater than 1,500
- Absolute lymphocytes greater than 500
- Platelets greater than 120,000
- Hb at least 10 g/dl
- Hepatic:
- -Bilirubin less than 2.0 mg/dl OR
- -SGOT less than 2 x ULN
- Renal:
- Creatinine no greater than 2.0 mg/dl OR
- Creatinine clearance at least 40 ml/min
- Rheumatologic:
- -ANA no greater than upper limit of normal, or ANA abnormal in absence of clinical signs of autoimmunity.
- Rheumatoid factor (RF) no greater than upper limit of normal, or RF abnormal in absence of clinical signs of autoimmunity.
- Anti-ds DNA no greater than upper limit of normal, or anti ds DNA abnormal in absence of clinical signs of autoimmunity.
- Immunologic:
- Influenza serology (assessment made at time of screening).
- Assessment of DTH response to a standard anergy panel (to include candida, trichophyton and tetanus) or to a Multitest CMI (a disposable kit for DTH testing with standardized preloaded antigens).
- Endocrine:
- -TSH, T3, and T4 no greater than upper limit of normal
- Radiographic:
- Baseline bone scan
- Baseline CT or MRI of abdomen and pelvis
Exclusion
- Disease Characteristics -No active CNS metastases
- Prior/Concurrent Therapy
- Biologic therapy:
- No prior autologous or allogeneic tumor vaccines
- No concurrent other immunotherapy
- Chemotherapy
- -Not previously treated with more than 2 chemotherapy regimens
- No concurrent chemotherapy
- Radiotherapy --No concurrent radiotherapy
- Patient Characteristics -Cardiovascular: No NYHA class III/IV status No active angina, clinically significant cardiac arrythmia, recent (6 months) myocardial infarction
- Pulmonary:
- -No severe debilitating pulmonary disease
- Other:
- No active infection requiring antibiotics
- No active pain requiring chronic opioid analgesics.
- Not HIV, hepatitis B or hepatitis C virus positive; anti-HIV, HbsAg and Hep C antibody negative
- No history of hypersensitivity to vaccine components
- No serious uncontrolled medical illness
- No currently active second malignancy other than non-melanoma skin cancer (note: a patient is NOT considered to have currently active malignancy if they have completed therapy and are now considered by their physician to be at less than 30% risk for relapse)
- No history of total lymph node irradiation
- No history of vasculitis, including but not limited to systemic necrotizing vasculitides (polyarteritis nodosa group), hypersensitivity vasculitis, Wegener's granulomatosis.
- No history of autoimmune disease.
- No use of hydroxyurea within 45 days of study entry
- No receipt of immune modulators or suppressors within 30 days prior to study entry, including but not limited to interferons and thalidomide. No active requirement for corticosteroids; prior use is acceptable.
- No psychiatric illness or social condition that, in the opinion of the investigator, would interfere with adherence to study requirements.
- No alcohol or drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00289341
Start Date
March 1 2002
End Date
November 1 2008
Last Update
January 18 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rockefeller University Hospital
New York, New York, United States, 10021