Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Vaccine Therapy in Treating Patients With Stage IV Melanoma

11 mai 2011 mis à jour par: Mannkind Corporation

A Phase I/II Pilot Study Of Intranodal Delivery Of A Plasmid DNA (Synchrovax SEM Vaccine) In Stage IV Melanoma Patients

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Infusing the vaccine directly into a lymph node may cause a stronger immune response and kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma.

Aperçu de l'étude

Description détaillée

OBJECTIVES:

  • Determine the maximum tolerated dose of intranodal Synchrovax SEM plasmid DNA vaccine in patients with stage IV melanoma.
  • Determine the safety and tolerability of this drug in these patients.
  • Determine the immunological response, as measured by changes in frequency of T cells specific against vaccine-encoded epitopes before and after treatment, in patients treated with this drug.
  • Determine the clinical response, as measured by lactic dehydrogenase levels and radiologic assessment of lesions, in patients treated with this drug.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive Synchrovax SEM plasmid DNA vaccine by continuous intranodal infusion on days 1-4. Treatment repeats every 14 days for up to 4 courses in the absence of unacceptable toxicity. Patients with evidence of stable or responding disease are eligible for 4 additional courses of treatment.

Cohorts of 6 patients receive escalating doses of Synchrovax SEM plasmid DNA vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 10 days after the last dose of study drug.

PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for this study.

Type d'étude

Interventionnel

Inscription (Réel)

19

Phase

  • Phase 2
  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Arizona
      • Tucson, Arizona, États-Unis, 85724
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • California
      • Los Angeles, California, États-Unis, 90089
        • USC/Norris Comprehensive Cancer Center and Hospital
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02118
        • Cancer Research Center at Boston Medical Center
    • Minnesota
      • Rochester, Minnesota, États-Unis, 55905
        • Mayo Clinic Cancer Center
    • Oregon
      • Portland, Oregon, États-Unis, 97213-2967
        • Earle A. Chiles Research Institute at Providence Portland Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IV melanoma
  • Must have tumor tissue available for determining antigen expression

    • At least 10% of tumor cells must stain positive for Melan-A/Mart-1 by immunohistochemistry
  • HLA-A2 positive
  • No brain metastases unless completely resected or without evidence of disease after treatment

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • More than 3 months

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm3
  • WBC at least 3,000/mm3
  • Platelet count at least 75,000/mm3
  • Hemoglobin at least 9 g/dL

Hepatic:

  • SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN
  • Bilirubin no greater than 1.5 times ULN
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative

Renal:

  • Creatinine no greater than 1.5 times ULN
  • Urea no greater than 2.6 times ULN

Other:

  • Not pregnant, nursing, or planning to become pregnant within 6 months of treatment completion
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No medical, sociological, or psychological impediments that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy
  • At least 4 weeks since prior immunomodulatory drugs
  • No other concurrent immunotherapy
  • No concurrent immunomodulatory drugs

Chemotherapy:

  • At least 4 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior systemic corticosteroids
  • No concurrent systemic corticosteroids

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • At least 4 weeks since prior investigational drugs
  • No other concurrent investigational drugs

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Cohort 1
The first cohort of 6 patients received 500 ug of Synchrovax SEM plasmid DNA vaccine. All patients were to be monitored for dose limiting toxicities DLTs) for a minimum of 2 weeks after their second infusion of vaccine on Day 15 before allowing patients to enroll at the next dose group. The decision to progress to the next dose group was to be based on occurrence of DLTs observed in 1 or fewer (<33%) patients of a 6 patient cohort.
Cancer Vaccine, Immunotherapy, 500 ug
Cancer Vaccine, Immunotherapy, 1000 ug
Cancer Vaccine, Immunotherapy, 1500 ug
Expérimental: Cohort 2
The second cohort of 6 patients received 1000 ug of Synchrovax SEM plasmid DNA vaccine. All patients were to be monitored for dose limiting toxicities DLTs) for a minimum of 2 weeks after their second infusion of vaccine on Day 15 before allowing patients to enroll at the next dose group. The decision to progress to the next dose group was to be based on occurrence of DLTs observed in 1 or fewer (<33%) patients of a 6 patient cohort.
Cancer Vaccine, Immunotherapy, 500 ug
Cancer Vaccine, Immunotherapy, 1000 ug
Cancer Vaccine, Immunotherapy, 1500 ug
Expérimental: Cohort 3
The third cohort of 6 patients received 1500 ug of Synchrovax SEM plasmid DNA vaccine. The maximum tolerated dose (MTD) was to be determined by the observation of DLT at each dose group.
Cancer Vaccine, Immunotherapy, 500 ug
Cancer Vaccine, Immunotherapy, 1000 ug
Cancer Vaccine, Immunotherapy, 1500 ug

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
The primary objective of the study was to evaluate the safety and tolerability of Synchrovax® pSEM Vaccine measured by the adverse event and severe adverse event profile.

Mesures de résultats secondaires

Mesure des résultats
The secondary objective of the study was to determine the immunological response of patients as measured by tetramer assay and to assess clinical response by LDH levels and radiological assessment of lesions.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chaise d'étude: Chief Scientific Officer, Mannkind Corporation

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2002

Achèvement primaire (Réel)

1 mars 2003

Achèvement de l'étude (Réel)

1 avril 2003

Dates d'inscription aux études

Première soumission

9 avril 2002

Première soumission répondant aux critères de contrôle qualité

26 janvier 2003

Première publication (Estimation)

27 janvier 2003

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

12 mai 2011

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 mai 2011

Dernière vérification

1 mai 2011

Plus d'information

Termes liés à cette étude

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 Mélanome (Peau)

Essais cliniques sur MKC1106-MT

3
S'abonner