- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00406939
Vector Delivery of the IL-12 Gene in Men With Prostate Cancer
Phase I Study of Adenoviral Vector Delivery of The IL-12 Gene in Men With Recurrence or Persistent Cancer of the Prostate After Primary Therapy With or Without Metastatic Disease (SPORE)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The development of a clinical trial for gene therapy in prostate cancer will be coordinated with our collaborators at Baylor involved in similar studies in order to facilitate the approval process. We have submitted a proposal to the NIH Recombinant DNA Advisory Committee (RAC) committee for accelerated review. A detailed clinical protocol and informed consent for a Phase I clinical trial of gene therapy for prostate cancer has been approved by the Baylor Affiliates Review Board and the FDA.
Human subjects included in this project will be limited to men who have biopsy-proven local recurrence or persistence of cancer in the prostate gland with or without metastatic disease after hormone therapy, cryosurgery and/or definitive irradiation therapy. Patients with biopsy-proven prostate cancer, clinical stages T1-T3, Nx-N1 or M0-M1 are eligible. Biologically active local recurrence of tumor will be defined as biopsy-proven cancer in the prostate, at least one year after the completion of radiation therapy, in a patient who has a rising serum PSA level on at least 3 separate occasions at least 2 weeks apart.
Patients will also be carefully followed to document toxicity, using standard CTEP toxicity criteria. Responses will be categorized as follows: progressive disease, stable disease, partial objective response, and complete objective response. Progressive disease will be defined as a rise in the serum PSA level by 25% in the first 3 months and thereafter, a positive biopsy in conjunction with an enlarging nodule on digital rectal exam or an enlarging hypoechoic lesion on ultrasound, or the development of new symptoms clearly related to the cancer in the presence of a positive biopsy, or the presence on biopsy of cancer of higher grade or cancer that is more extensive. A complete response will be defined as a serum PSA level that decreases to less than 1 ng/ml, in combination with a negative biopsy of the prostate and the absence of symptoms referable to cancer. A partial objective response would be a PSA level that decreases by at least 50% compared to baseline in association with a biopsy result that shows clearly diminished or minimum but persistent cancer cells.
This Phase I study is designed to evaluate the safety of Adv/IL-12 gene therapy with an intent to offer a potential therapeutic advantage. The potential risks associated with the use of gene therapy in this group would appear reasonable in so far as evaluations will be frequent and progression (should it occur) will be found early and allow rapid movement of the patient to other possible therapies. Effectiveness will be monitored by serum PSA, transrectal ultrasound of the prostate, prostate biopsy and comparison of survival times to historical survival times for patients with radiation recurrent prostate tumors. Additional research laboratory analyses will be performed to evaluate the immune response engendered by this gene therapy protocol. This will consist of analysis of serum and/or plasma and urine for systemic cytokine production using standard ELISA methodologies that we have performed in previous studies. In addition we will collect whole blood for the analysis of T cells by flow cytometry. We have established protocols for this analysis that can detect total CD4 and CD8 cells as well as those that express markers of activation such as HLA/DR.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Texas
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Houston, Texas, États-Unis, 77030
- Baylor College of Medicine Scott Department of Urology
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Men who have biopsy-proven local recurrence or persistence of cancer in the prostate gland with or without metastatic disease after the hormone therapy, cryosurgery, and/or the completion of definitive radiation therapy for at least one year.
- Patients must have evidence of biologically active local recurrence of tumor as demonstrated by a rising serum PSA level on at least 3 separate occasions at least 2 weeks apart, and that the serum PSA be below 50 ng/ml.
- The patient will possess the ability to give informed consent and express a willingness to meet all the expected requirements of the protocol for the duration of the study. (Informed Consent Document).
Patients must have adequate baseline organ function as assessed by the following laboratory values before initiating the protocol.
- Adequate renal function with serum creatinine less than 1.5 mg/dl or creatinine clearance greater than 45 ml/min/m2.
- Platelet count greater than 100,000 platelets/mm3.
- Absolute neutrophil count greater than 1000/mm3.
- Hemoglobin greater than 8.5 mg/dl
- Normal partial thromboplastin time (PTT) and Pro-Thrombin Time (PT).
- Bilirubin less than 2.5 mg/dl, SGOT and SGPT less than 2.0x normal.
Exclusion Criteria:
- Acute infection: Acute infection is defined as any viral, bacterial or fungal infection, which requires specific therapy.
- Symptomatic metastasis.
- Metastatic lesions in the CNS/spinal cord or organs that could become life or function threatening within 3 months.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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To determine whether the treatment is associated with significant toxicity.
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Mesures de résultats secondaires
Mesure des résultats |
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Collection of data on tumor responses produced by the study treatment.
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Collection data on immune responses induced by the study treatment.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Brian J. Miles, M.D., Baylor College of Medicine
Publications et liens utiles
Publications générales
- Shalev M, Kadmon D, Teh BS, Butler EB, Aguilar-Cordova E, Thompson TC, Herman JR, Adler HL, Scardino PT, Miles BJ. Suicide gene therapy toxicity after multiple and repeat injections in patients with localized prostate cancer. J Urol. 2000 Jun;163(6):1747-50.
- Fujita T, Timme TL, Tabata K, Naruishi K, Kusaka N, Watanabe M, Abdelfattah E, Zhu JX, Ren C, Ren C, Yang G, Goltsov A, Wang H, Vlachaki MT, Teh BS, Butler EB, Thompson TC. Cooperative effects of adenoviral vector-mediated interleukin 12 gene therapy with radiotherapy in a preclinical model of metastatic prostate cancer. Gene Ther. 2007 Feb;14(3):227-36. doi: 10.1038/sj.gt.3302788. Epub 2006 Oct 5.
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- #H-6836
- P50CA058204 (Subvention/contrat des NIH des États-Unis)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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 .
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