- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00001382
A Phase I Study of Recombinant Vaccinia Virus That Expresses Prostate Specific Antigen in Adult Patients With Adenocarcinoma of the Prostate
Aperçu de l'étude
Description détaillée
Type d'étude
Inscription
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Maryland
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Bethesda, Maryland, États-Unis, 20892
- National Cancer Institute (NCI)
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate as follows: Unresectable and/or incurable tumor AND Tumor progression after at least 1 prior hormonal manipulation (i.e., LHRH agonist/flutamide or orchiectomy). LHRH agonist may by continued concurrently with protocol therapy.
New bone or soft tissue lesions OR Serum PSA that has risen on 3 successive evaluations at least 1 week apart during and/or after hormonal therapy. If PSA is below 4 ng/mL, measurable disease with positive immunohistochemical stain for PSA is required.
No history of allergy to eggs.
No history of or active CNS metastases.
Symptomatic spinal or other bony metastasis should be irradiated prior to entry.
Bi-dimensionally measurable disease not required.
PRIOR/CONCURRENT THERAPY:
Biologic Therapy:
No concurrent Biologic Therapy.
Must fully recover from prior Biologic Therapy.
Chemotherapy:
At least 4 weeks since prior chemotherapy and fully recovered.
No more than 1 prior chemotherapy regimen.
No concurrent chemotherapy.
Endocrine Therapy:
See Disease Characteristics.
At least 4 weeks since prior hormonal therapy and fully recovered.
No concurrent steroids.
Radiotherapy:
At least 4 weeks since prior radiation therapy and fully recovered.
No prior radiotherapy to more than 50% of nodal groups.
No concurrent radiotherapy.
Surgery:
At least 4 weeks since prior surgery, with surgical scar healed.
No prior splenectomy.
PATIENT CHARACTERISTICS:
Age: Over 18.
Performance status: Zubrod (ECOG) 0-2.
Hematopoietic:
Absolute granulocyte count greater than 2,000/mm(3);
Platelet count greater than 100,000/mm(3);
Hemoglobin greater than 8.0 g/dL.
Hepatic:
Bilirubin less than 1.6 mg/dL;
AST and ALT less than 4 times normal.
Renal: Creatinine less than 1.6 mg/dL.
Immunologic:
Prior vaccinia (for smallpox immunization) required, with proof of vaccination as follows: Detectable anti-vaccinia antibodies, Physician certification of prior vaccination, Patient recollection or appropriate vaccination-site scar sufficient in patients over age 25, Delayed-type hypersensitivity skin testing (to mumps, Candida, and Trichophyton antigens) normal Quantitative immunoglobulins normal.
No evidence of immunocompromise, i.e.:
No HIV antibody;
No eczema or atopic dermatitis;
No autoimmune neutropenia, thrombocytopenia, or hemolytic anemia;
No systemic lupus erythematosus, Sjogren syndrome, or scleroderma;
No myasthenia gravis;
No Goodpasture syndrome;
No Addison's disease, Hashimoto's thyroiditis, or active Graves' disease;
No other autoimmune disease or diagnosis of altered immune function.
OTHER:
No active case or history of extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns, or other traumatic or pruritic skin condition.
No active infection requiring antibiotics (including chronic suppressive therapy). At least 3 days since antibiotic therapy.
No history of seizures, encephalitis, or multiple sclerosis.
No other serious intercurrent illness.
Able to avoid close contact with the following individuals for at least 2 weeks after vaccination (i.e., no such individuals as household members and no care-giving responsibilities for such individuals): Children under age 3, Pregnant women, Individuals with eczema or skin conditions defined above, Leukemia or lymphoma patients, HIV-positive individuals, Patients receiving immunosuppressive therapy, Any other immunosuppressed individuals.
No prior malignancy unless curatively treated and patient has been in remission for at least 2 years (excluding squamous cell or basal cell carcinoma of the skin or carcinoma in situ of the cervix).
Able and willing to travel to the NIH, NCI-NMOB, or the Lombardi Cancer Center at Georgetown University for treatment and follow-up.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies virales
- Infections
- Tumeurs par type histologique
- Tumeurs
- Tumeurs urogénitales
- Tumeurs par site
- Carcinome
- Tumeurs, glandulaires et épithéliales
- Tumeurs génitales, homme
- Maladies de la prostate
- Infections par le virus de l'ADN
- Infections à Poxviridae
- Tumeurs prostatiques
- Adénocarcinome
- Vaccine
Autres numéros d'identification d'étude
- 940118
- 94-C-0118
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur PROSTVAC
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National Cancer Institute (NCI)ComplétéCancer de la prostateÉtats-Unis
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National Cancer Institute (NCI)Complété
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National Cancer Institute (NCI)Actif, ne recrute pasCancer de la prostateÉtats-Unis
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National Cancer Institute (NCI)Actif, ne recrute pasCancer de la prostate | Tumeurs de la prostate | Tumeurs prostatiquesÉtats-Unis
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National Cancer Institute (NCI)ComplétéTumeurs prostatiques | Cancer de la prostate | Tumeurs, ProstateÉtats-Unis
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Bavarian NordicComplétéCancer de la prostate métastatiqueÉtats-Unis, Espagne, Allemagne, Pays-Bas, Belgique, Royaume-Uni, Australie, Danemark, France, Canada, Israël, Fédération Russe, Porto Rico, Estonie, Pologne, Islande
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Medical University of South CarolinaBavarian NordicComplétéTumeurs prostatiquesÉtats-Unis
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University of UtahGenentech, Inc.; Bavarian NordicRetiréAdénocarcinome de la prostateÉtats-Unis
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National Cancer Institute (NCI)ComplétéCancer de la prostateÉtats-Unis
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Bavarian NordicNational Cancer Institute (NCI); Therion Biologics CorporationComplétéCancer de la prostateÉtats-Unis