- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00289341
Safety and Effectiveness of a Vaccine for Prostate Cancer That Uses Each Patients' Own Immune Cells.
A Phase I/II Study of Autologous Dendritic Cells Pulsed With Apoptotic Tumor Cells (DC/LNCaP) Administered Subcutaneously to Prostate Cancer Patients.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10021
- Rockefeller University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
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 Criteria:
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: Placebo
12 patients in the placebo Arm for 8 weeks followed by DC/LNCAP, DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks.
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Subcutaneous injection of vaccine vehicle only (5% DMSO in normal saline), followed by cross-over to Arm 1 design.
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Experimental: DC/LNCaP
12 patients, receiving DC/LNCaP, DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks
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Subcutaneous injection of DC/LNCaP, DC/LNCaP-M1, DC/KLH
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Adverse Event
Periodo de tiempo: End of blinded phase (wk 9)
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Occurrence of adverse events (AE) was compared between the placebo and vaccine groups during the blinded phase (the 1st 9 weeks).
At the end of this phase, all were unblinded, and those who received placebo crossed over to now receive vaccine.
All serious AEs and any other AEs that occurred 5 times or more are reported.
The exact binomial test was used to compare the occurrence of each AE between groups.
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End of blinded phase (wk 9)
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Immunogenicity of the DC/LNCaP Vaccine. Pre- vs Post-vaccination Bulk T Cell Proliferation (3H Thymidine Incorporation) by Type of Antigen. The "Number" Indicated is the Median Difference of Post-Pre, of Each Antigen Group.
Periodo de tiempo: pre- vs post-vaccination. Pre-vaccination T cells were collected at Wk 0 and post-vaccination T cells were collected at Wk 13
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The difference between post minus pre-vaccination bulk T cell proliferation was calculated for each antigen.
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pre- vs post-vaccination. Pre-vaccination T cells were collected at Wk 0 and post-vaccination T cells were collected at Wk 13
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in PSA Slope, Pre- vs Post-vaccination.
Periodo de tiempo: pre- vs post- vaccination PSA slopes.
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To model the evolution of PSA (in log-scale) during the three study phases (pre-vaccine, vaccine, and post-vaccine phases), a mixed linear spline model was used.
Two knots (one at the start of the vaccine phase and the other at the start of the post-vaccine phase) were used to directly quantify the differences in slopes between each phase.
To account for the heterogeneous treatment effect and the repeated measures structure, random effects are incorporated into the model.
For the general model, random effects for the intercept, slope and the first knot were considered.
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pre- vs post- vaccination PSA slopes.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Robert B. Darnell, MD, PHD, Rockefeller University
Publicaciones y enlaces útiles
Publicaciones Generales
- Frank MO, Kaufman J, Parveen S, Blachere NE, Orange DE, Darnell RB. Dendritic cell vaccines containing lymphocytes produce improved immunogenicity in patients with cancer. J Transl Med. 2014 Dec 5;12:338. doi: 10.1186/s12967-014-0338-3.
- Frank MO, Kaufman J, Tian S, Suarez-Farinas M, Parveen S, Blachere NE, Morris MJ, Slovin S, Scher HI, Albert ML, Darnell RB. Harnessing naturally occurring tumor immunity: a clinical vaccine trial in prostate cancer. PLoS One. 2010 Sep 1;5(9):e12367. doi: 10.1371/journal.pone.0012367.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RDA 0466
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