- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Texas
-
Houston, Texas, Forente stater, 77030
- Baylor College of Medicine Scott Department of Urology
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
---|
To determine whether the treatment is associated with significant toxicity.
|
Sekundære resultatmål
Resultatmål |
---|
Collection of data on tumor responses produced by the study treatment.
|
Collection data on immune responses induced by the study treatment.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Brian J. Miles, M.D., Baylor College of Medicine
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- #H-6836
- P50CA058204 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Prostatiske neoplasmer
-
Guangzhou First People's HospitalFullført
-
Rabin Medical CenterFullførtDesmoid fibromatose | Desmoid | Desmoid fibromatose i huden | Desmoid Neoplasm of Chest Wall | Desmoid-svulst forårsaket av somatisk mutasjon | Aggressive fibromatoser | Fibromatose DesmoidIsrael
Kliniske studier på IL-12 gene
-
Neumedicines Inc.Department of Health and Human ServicesFullførtHematopoietisk syndrom på grunn av akutt strålingssyndromForente stater
-
Neumedicines Inc.Department of Health and Human ServicesFullførtHematopoietisk syndrom på grunn av akutt strålingssyndromForente stater
-
University Health Network, TorontoOzmosis Research Inc.RekrutteringAkutt myeloid leukemiCanada
-
National Cancer Institute (NCI)FullførtEpiteliale svulster, ondartede | Epiteliale neoplasmer, ondartede | Ondartet mesenkymal svulstForente stater
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)FullførtTilbakevendende egglederkarsinom | Tilbakevendende ovariekarsinom | Tilbakevendende primært peritonealt karsinom | Klarcellet ovariecystadenokarsinom | Endometrioid adenokarsinom på eggstokkene | Ovarialt seromucinøst karsinom | Serøst cystadenokarsinom på eggstokkene | Ovarialt udifferensiert karsinomForente stater
-
National Institute of Allergy and Infectious Diseases...AvsluttetHIV-infeksjoner | Kryptosporidiose
-
University of PennsylvaniaDrexel UniversityFullførtHIV-infeksjonForente stater
-
National Institute of Allergy and Infectious Diseases...Fullført
-
OncoSec Medical IncorporatedAvsluttetMycosis Fungoides (MF) | Kutane T-celle lymfomer (CTCL)Forente stater
-
OncoSec Medical IncorporatedNational Cancer Institute (NCI)FullførtMerkel cellekarsinomForente stater