Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer
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Purpose
RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill prostate tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: therapeutic autologous dendritic cells |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Safety and Feasibility Study of Active Immunotherapy in Patients With Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed With Antigen Encoded in Amplified Autologous Tumor RNA |
| Enrollment: | 3 |
| Study Start Date: | November 2000 |
| Study Completion Date: | March 2003 |
OBJECTIVES:
- Determine the safety and feasibility of autologous dendritic cells transfected with autologous total tumor RNA in patients with metastatic prostate cancer.
- Determine the presence, frequency, and activation status of tumor specific and prostate specific antigen (PSA) specific cellular immune responses in patients treated with this regimen.
- Determine delayed-type hypersensitivity reactions to PSA protein and other recall antigens in patients before and after being treated with this regimen.
- Determine clinical responses based on clinical and biochemical (PSA) response criteria in patients treated with this regimen.
- Determine a platform for immunological treatment using dendritic-cell based tumor vaccines in these patients.
OUTLINE: This is a dose escalation study.
Tumor tissue and peripheral blood stem cells are collected from patients and cultured in vitro with sargramostim (GM-CSF) and interleukin-4 for 7 days to produce dendritic cells (DC). Patients receive autologous DC transfected with autologous prostate carcinoma RNA intradermally once weekly on weeks 0-3 for a total of 4 doses.
Cohorts of 3-6 patients receive escalating doses of DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at weeks 6, 8, 10, and 12; every 3 months for 9 months; and then annually for 2 years.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study within 20 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic adenocarcinoma of the prostate
- Stage D1-3
- Regional lymph node, bone, visceral, or soft tissue metastases
- No transitional cell or small cell carcinoma
- Testosterone less than 50 mg/L if prior treatment with luteinizing hormone releasing hormone (LHRH) analogues or estrogens
- Evidence of androgen refractory disease after surgical castration and discontinuation of LHRH analogue therapy
- No previously irradiated or new CNS metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- More than 6 months
Hematopoietic:
- WBC at least 3,000/mm^3
- Hemoglobin at least 9 g/dL
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than 2.0 mg/dL
- PT at least 11.3 seconds but no greater than 13.3 seconds
- PTT at least 20.1 seconds but no greater than 32.9 seconds
- No hepatic disease
- No viral hepatitis
Renal:
- Creatinine less than 2.5 mg/dL
Cardiovascular:
- No New York Heart Association class III or IV heart disease
Pulmonary:
- No asthma
- No chronic obstructive pulmonary disease
- No severe lung disease
Other:
- No other medical illness or psychological impediment that would preclude study
- No other concurrent malignancy except nonmelanoma skin cancer or controlled superficial bladder cancer
- No active acute or chronic infection including symptomatic urinary tract infection
- No autoimmune disease (e.g., inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis)
- HIV negative
- Adequate peripheral vein access
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Prior biologic therapy allowed
- No other concurrent immunotherapy
Chemotherapy:
- Prior chemotherapy allowed
- No concurrent chemotherapy
Endocrine therapy:
- See Disease Characteristics
- At least 4 weeks since prior non-steroidal hormonal therapy if increase in PSA while receiving non-steroidal hormonal therapy
- At least 6 weeks since prior steroids
- Concurrent LHRH analogues for gonadal androgen suppression allowed
- No concurrent steroid therapy
- No concurrent corticosteroids
Radiotherapy:
- See Disease Characteristics
- Prior palliative radiotherapy for bone metastases allowed
- Prior prostatic radiotherapy allowed
- At least 4 weeks since prior radiotherapy
- At least 12 weeks since prior strontium chloride Sr 89
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
Other:
- Recovered from prior therapy
- No concurrent immunosuppressive agents (e.g., azathioprine or cyclosporine)
Contacts and Locations| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Study Chair: | Johannes Vieweg, MD | Duke Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00010127 History of Changes |
| Other Study ID Numbers: | 0759, DUMC-000759-00-4R1, DUMC-DORIS-99043, NCI-G00-1910, CDR0000068447 |
| Study First Received: | February 2, 2001 |
| Last Updated: | March 19, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Duke University:
|
adenocarcinoma of the prostate stage IV prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013