- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00045149
Biological Therapy in Treating Patients With Metastatic Melanoma
Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen Specific T Cell Clones Targeting Cancer Testis Antigens for Patients With Metastatic Melanoma
RATIONALE: Biological therapies such as cellular adoptive immunotherapy use different ways to stimulate the immune system and stop cancer cells from growing. Treating a person's white blood cells in the laboratory and then reinfusing them may cause a stronger immune response and kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES:
Primary
- Determine the safety and toxicity of cellular adoptive immunotherapy comprising autologous CD8+ cytotoxic T-lymphocyte clones targeting cancer-testis antigens in patients with metastatic melanoma.
- Determine the duration of in vivo persistence of this therapy in these patients.
Secondary
- Evaluate the antitumor effects of this therapy in these patients.
OUTLINE: Patients undergo leukapheresis to obtain peripheral blood mononuclear cells and then CD8+ cytotoxic T-lymphocyte (CTL) clones are generated ex vivo. Patients receive cellular adoptive immunotherapy comprising autologous CD8+ CTL clones targeting cancer testis antigens IV over 30 minutes on day 1. Patients also receive interleukin-2 subcutaneously every 12 hours on days 1-14 of courses 2-4. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who demonstrate a clinical response after completion of the fourth course are eligible to receive additional T-cell infusions.
Patients are followed for 9 months.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 3 years.
Type d'étude
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Washington
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Seattle, Washington, États-Unis, 98109-1024
- Fred Hutchinson Cancer Research Center
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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
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic melanoma
- Stage IV disease
- HLA-A1, -A2, and -A3 positive
- MAGE-1 or -3 positive by histology
- Bidimensionally measurable disease by palpation on clinical examination, x-ray, or CT scan
- No CNS metastases
PATIENT CHARACTERISTICS:
Age
- 18 to 75
Performance status
- Karnofsky 80-100%
Life expectancy
- More than 6 months
Hematopoietic
- Not specified
Hepatic
- Bilirubin ≤ 1.6 mg/dL
- SGOT ≤ 3 times upper limit of normal
- PT ≤ 1.5 times control
Renal
- Creatinine ≤ 2.0 mg/dL
- Calcium ≤ 12 mg/dL
Cardiovascular
- No congestive heart failure
- No clinically significant hypotension
- No symptoms of coronary artery disease
- No cardiac arrhythmias on electrocardiogram requiring drug therapy
- Patients with prior cardiovascular disease or the presence of any of the above abnormalities undergo a cardiac evaluation, which may include a stress test and/or echocardiogram
Pulmonary
- No clinically significant pulmonary dysfunction by medical history or physical examination
- FEV_1 ≥ 60% of normal
- DLCO ≥ 55% (corrected for hemoglobin)
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No retinitis or choroiditis
- No active infections or oral temperature greater than 38.2 degrees Celsius within the past 72 hours
- No systemic infection requiring chronic maintenance or suppressive therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No other concurrent immunotherapy (e.g., other interleukins, interferons, melanoma vaccines, intravenous immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer cell therapy)
Chemotherapy
- At least 3 weeks since prior standard or experimental chemotherapy
- 1-2 courses of prior cytoreductive chemotherapy for bulky disease allowed
Endocrine therapy
- No concurrent systemic steroids (except for toxicity management)
Radiotherapy
- At least 3 weeks since prior radiotherapy
Surgery
- Not specified
Other
- At least 3 weeks since prior immunosuppressive therapy
- No concurrent pentoxifylline
- No other concurrent investigational agents
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Masquage: Aucun (étiquette ouverte)
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs par type histologique
- Tumeurs
- Tumeurs neuroectodermiques
- Tumeurs, cellules germinales et embryonnaires
- Tumeurs, tissu nerveux
- Tumeurs neuroendocrines
- Nevi et mélanomes
- Mélanome
- Agents anti-infectieux
- Agents antiviraux
- Agents anti-VIH
- Agents antirétroviraux
- Agents antinéoplasiques
- Aldesleukine
Autres numéros d'identification d'étude
- 1588.00
- FHCRC-1588.00
- NCI-H02-0091
- CDR0000256451 (Identificateur de registre: PDQ)
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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