- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00668382
Evaluate The Toxicity And Feasibility Of Intra-Tumoral Injection
Phase I Study To Evaluate The Toxicity And Feasibility Of Intra-Tumoral Injection Of Alpha-Gal Glycosphingolipids In Patients With Advanced Or Refractory Solid Tumors
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Massachusetts
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Worcester, Massachusetts, États-Unis, 01655-0108
- University of Massachusetts Medical School
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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:
- Patients with solid tumors who have failed standard therapies, or are not candidates for standard therapies.
- Patients must have at least one measurable lesion that is accessible and suitable for injection of the GSL alpha-GAL.
- Patients should not be undergoing any active treatment with chemotherapy, radiotherapy, or steroids (either because the patient or the treating physician have decided not to employ these therapies at this time, or because they had already been tried and failed). If they have been treated with these modalities, the treatments should have been completed at least two weeks prior to date of injection of GSL alpha-GAL.
- Patients should be judged by the investigator to be able to undergo safely the procedure needed to inject the tumor with GSL alpha-GAL.
- Age equal or over 18 years old.
- ECOG (Eastern Cooperative Oncology Group ) performance of less than 2. (International Normalized Ratio) INR less than 1.5 and a (Partial Thromboplastin Time) PTT no greater than normal limits within 1 week prior to intra-tumoral injection (For patients who requires invasive procedure for intra-tumoral injection).
Laboratory Criteria (completed equal or less 2 weeks before enrollment) Hematologic: (White Blood Cell Count) WBC equal or above 3500/millimeter-cubed or (Absolute Neutrophil Count) ANC equal or above 1500/millimeter-cubed and platelet count equal or above 100,000/ millimeter-cubed.
Hepatic: Total bilirubin equal or less 4.0 milligrams/deciliter. Renal: Creatinine equal or less 2.2 milligrams/deciliter.
- Patients must be negative for HIV (circulating antibody), Hepatitis B (circulating antigen), and Hepatitis C (circulating antibody).
- Patients should have an expected survival of more than 6 weeks and should not have other systemic anti-tumor treatments planned during this time frame.
Exclusion Criteria:
- Patients who are pregnant (as determined by a positive serum HCG (Human Chorionic Gonadotropin) in patients of childbearing potential) or nursing.
- Patients under the age of 18.
- Patients with severe infections or septicemia.
- Patients with a history of autoimmune disease.
- Patients in, or about to be in, active treatment with chemotherapy or steroids.
- Patients who refuse HIV/hepatitis testing and patients who do not sign an approved consent form.
- Patient has received other investigational drugs within 14 days before enrollment or is expected to participate in an experimental drug study during this study treatment.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Alpha-Gal Glycosphingolipid injection
Intervention: Intratumoral injection of a single dose of Alpha-Gal Glycosphingolipid (0.1 mg,1mg, 10mg)
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Intra-tumoral injection of Alpha-Gal Glycosphingolipid to evaluate toxicity
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Number of Subjects With Greater Than Grade 3 or 4 Toxicity
Délai: 1 month
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Grade 3/4 Toxicity occurring in a participant within a month of intratumoral injection
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1 month
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Giles Whalen, MD, University of Massachusetts, Worcester
Publications et liens utiles
Publications générales
- Lugade AA, Moran JP, Gerber SA, Rose RC, Frelinger JG, Lord EM. Local radiation therapy of B16 melanoma tumors increases the generation of tumor antigen-specific effector cells that traffic to the tumor. J Immunol. 2005 Jun 15;174(12):7516-23. doi: 10.4049/jimmunol.174.12.7516.
- Malmberg KJ. Effective immunotherapy against cancer: a question of overcoming immune suppression and immune escape? Cancer Immunol Immunother. 2004 Oct;53(10):879-92. doi: 10.1007/s00262-004-0577-x. Epub 2004 Jul 28.
- DiGiacomo A, North RJ. T cell suppressors of antitumor immunity. The production of Ly-1-,2+ suppressors of delayed sensitivity precedes the production of suppressors of protective immunity. J Exp Med. 1986 Oct 1;164(4):1179-92. doi: 10.1084/jem.164.4.1179. Erratum In: J Exp Med 1986 Dec 1;164(6):2131.
- Shimizu J, Yamazaki S, Sakaguchi S. Induction of tumor immunity by removing CD25+CD4+ T cells: a common basis between tumor immunity and autoimmunity. J Immunol. 1999 Nov 15;163(10):5211-8.
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
- UM200702
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Essais cliniques sur Alpha-Gal Glycosphingolipid
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University of Massachusetts, WorcesterComplété
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Assistance Publique - Hôpitaux de ParisShire International GmbHComplété
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University Health Network, TorontoOzmosis Research Inc.Complété
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University of North Carolina, Chapel HillRevivicor, IncRecrutementVomissement | Syndrome de l'intestin irritable | Douleur abdominale | Diarrhée | Syndrome Alpha-GalÉtats-Unis
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Immutep S.A.S.UmanisComplétéCarcinome à cellules rénales de stade IVFrance
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Immutep S.A.S.UmanisComplétéCancer du sein métastatiqueFrance
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Chang Gung Memorial HospitalRecrutement
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Immutep S.A.S.SGS Aster-Cephac (CRO)Complété
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Immutep S.A.S.SGS Aster-Cephac (CRO)Complété
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Aswan University HospitalRecrutementIschémie cérébraleEgypte