High Dose Interleukin-2 (IL-2) Therapy In "Lymphodepleted Primed" Patients With Metastatic Melanoma
aldesleukin
+ sargramostim
+ cyclophosphamide
Mélanome+8
+ Néoplasmes germinaux et embryonnaires
+ Néoplasmes par type histologique
Étude thérapeutique
Résumé
Date de début de l'étude : 1 février 2004
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Determine the objective response rate in lymphodepleted patients with metastatic melanoma treated with cyclophosphamide, fludarabine, and high-dose interleukin-2. * Determine the feasibility of this regimen in these patients. Secondary * Determine the quality and quantity of lymphocyte recovery in these patients during and after treatment with this regimen. * Determine time to disease progression and survival in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive lymphodepleting therapy comprising cyclophosphamide IV over 1 hour on days 1 and 2 and fludarabine IV over 30 minutes on days 3-7. Patients then receive high-dose interleukin-2 IV every 8 hours (14 doses) on days 8-12 and 22-26. Patients also receive sargramostim (GM-CSF) subcutaneously beginning on day 8 and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.20 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: * Histologically confirmed melanoma * Metastatic disease * Measurable disease * No history of brain metastases * Over 18 * Karnofsky 60-100% * Life expectancy At least 12 weeks * Hematopoietic * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 75,000/mm\^3 * Hemoglobin ≥ 8.5 g/dL * aspartate aminotransferase ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * Bilirubin ≤ 2 times ULN (except for patients with Gilbert's syndrome) * Hepatitis B and C negative * Creatinine ≤ 2.0 times ULN * Creatinine clearance ≥ 50 mL/min * Cardiovascular * Ejection fraction ≥ 50% * No evidence of congestive heart failure * No symptoms of coronary artery disease * No serious cardiac arrhythmias * No myocardial infarction within the past 6 months * Cardiac stress test negative or of low probability for patients \> 40 years of age OR who have had prior myocardial infarction \> 6 months ago * Pulmonary Forced expiratory volume 1 ≥ 2.0 liters OR at least 75% of predicted for height and age * Diffusing capacity of lung for carbon monoxide ≥ 60% * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative Exclusion Criteria: * No uncontrolled diabetes * No history of autoimmune disease * No active infection * No other concurrent significant illness that would preclude study participation * No other malignancy within the past 5 years except nonmelanoma skin cancer or non-invasive cancer (e.g., carcinoma in situ of the cervix, superficial bladder cancer without local recurrence, or carcinoma in situ of the breast) * At least 4 weeks since prior immunotherapy and recovered * No other concurrent anticancer biologic agents * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered * No concurrent chemotherapy * At least 4 weeks since prior steroid therapy * No concurrent corticosteroids * At least 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy * At least 4 weeks since prior surgery and recovered * No concurrent immunosuppressive therapy
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site