Terminé

Phase II Study of Abraxane Plus Ipilimumab in Patients With Metastatic Melanoma

0 critères remplis à partir de votre profilVoyez en un coup d'œil comment votre profil répond à chaque critère d'éligibilité.
Ce qui est testé

ABI-007

+ Ipilimumab

+ Phone Call

MédicamentComportemental
Qui peut participer

Néoplasmes+9

+ Néoplasmes par type histologique

+ Néoplasmes par site

De 12 à 70 ans
+15 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Phase 2
Interventionnel
Date de début : avril 2013
Voir le détail du protocole

Résumé

Sponsor principalM.D. Anderson Cancer Center
Dernière mise à jour : 8 février 2022
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 25 avril 2013

Date à laquelle le premier participant a commencé l'étude.

Study Drug Administration: If you are found to be eligible to take part in this study, you will receive ABI-007 by vein over about 30 minutes on Days 1, 8, and 15 of each 28-day cycle. During the first 3 months that you receive abraxane, you will also receive ipilimumab. You will receive ipilimumab by vein over about 90 minutes. You will receive it 4 times, each time about 3 weeks apart. You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks. Study Tests: Every week, blood (about 1 teaspoon) will be drawn for routine tests. Before each cycle of abraxane: Your performance status will be recorded. You will have a physical exam, including measurement of your weight and vital signs. Blood (about 1 teaspoon) will be drawn for routine tests. Blood (about 1 teaspoon) will be drawn for tests of the immune system (first 3 cycles only). You will be asked about any other drugs you may be taking and about any side effects you may be having. If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test. Every 8 weeks (+/- 7 days), you will have a chest x-ray and CT scans or MRI scans performed to check the status of the disease. Length of Study: You may receive ipilimumab for up to 3 months. You may continue taking abraxane for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse or intolerable side effects occur. If you stop receiving the study drugs for any reason, you will have an End-of-Treatment Visit. End-of-Treatment Visit: Within 14 days after you stop study treatment, you will come into the clinic for the End-of-Treatment Visit. At this visit, the following tests will be performed: You will have a physical exam, including measurement of your vital signs and weight. You will be asked about any other drugs you may be taking and any side effects you may be having. Blood (about 2 tablespoons) will be drawn for routine tests. If the study doctor thinks it is in your best interest, you will have a CT scan or MRI scan to check for side effects. Every 2 months for 6 months, then every 3 months for up to 2 years, you will also be contacted by telephone or during a routine clinic visit to see how you are doing. If you are called, each call should last about 5 minutes. This is an investigational study. Ipilimumab is FDA approved and commercially available for the treatment of metastatic melanoma. abraxane is FDA approved and commercially available for the treatment of metastatic breast cancer. It is investigational to use abraxane, either alone or in combination with ipilimumab, for the treatment of metastatic melanoma. Up to 64 patients will take part in this study. All will be enrolled at MD Anderson.

NCT01827111
Sponsor principalM.D. Anderson Cancer Center
Dernière mise à jour : 8 février 2022
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

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.
Détails du design

21 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 12 à 70 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

NéoplasmesNéoplasmes par type histologiqueNéoplasmes par siteNéoplasmes germinaux et embryonnairesNéoplasmes du tissu nerveuxMaladies de la peauNéoplasmes cutanésMaladies de la peau et des tissus conjonctifsTumeurs neuroectodermiquesNævus et MélanomesTumeurs neuroendocrinesMélanome

Critères

6 critères d'inclusion nécessaires pour participer
Patients between 12 years of age and 70 years of age with an ECOG performance status of 0 or 1 will be eligible
Patients should not have been previously treated with cytotoxic drugs and immunotherapeutic agents for unresectable Stage III or Stage IV disease. Prior Ipilimumab in metastatic setting is not allowed. Prior therapy may include one line of targeted therapy for metastatic disease ie BRAF or MEK inhibitor. At least 3 weeks should have passed since the last dose of prior adjuvant interferon therapy and prior targeted therapies, and all previous therapy related toxicities should have resolved before starting study treatment. Prior adjuvant interferon is permitted. Prior cytotoxic therapy in adjuvant or metastatic setting is not allowed. Prior Ipilimumab in adjuvant setting is not allowed. Prior adjuvant therapy with targeted therapy including but not limited to B-RAF, MEK inhibitors etc. is allowed. Prior palliative radiation therapy for metastatic melanoma is permitted provided the patient has unirradiated metastatic sites for response evaluation and has fully recovered from its toxicity
Patients with histologically documented diagnosis of advanced stage IV or unresectable stage III mucosal or cutaneous melanoma are eligible
They must have recurrent melanoma with measurable or evaluable sites of disease, 1.0 cm or larger, in order to assess the response to treatment by the immune-related response criteria (irRC)
Voir plus de critères
9 critères d'exclusion empêchent la participation
Patients who are unable to return for follow-up visits as required by this study. Patients with a history of second malignant tumor, other than the common skin cancers - basal and squamous carcinomas, within the past 3 years and uncertainty about the histological nature of the metastatic lesions. Cases with other types of malignancies should be reviewed and decided by the PI of the study
Patients who have had major surgery or radiation therapy within 21 days of starting treatment
Patients with >= grade 2 sensory neuropathy at baseline
Patients with bone metastases only
Voir plus de critères

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

Un seul groupe d'intervention est désigné dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. Ipilimumab 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses. Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes.

Objectifs de l'étude

Objectifs principaux

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

University of Texas MD Anderson Cancer Center

Houston, United StatesOuvrir University of Texas MD Anderson Cancer Center dans Google Maps
Terminé1 Centres d'Étude