Claims for Patent: 10,386,359

Summary for Patent: 10,386,359

Title:	Methods for determining whether a patient will achieve a response after radiation therapy
Abstract:	Disclosed are methods for determining whether a patient will achieve a response after radiation therapy, in particular a method for determining whether a patient suffering from a cancer will achieve a response after radiation therapy including the steps of i) determining the level of ceramide in a first blood sample obtained from the patient before radiation therapy, ii) determining the level of ceramide in a second blood sample obtained from the patient during or just after radiation therapy, iii) comparing the level determined at step i) with the level determined at step ii) and iv) concluding that the patient will achieve response when the level determined at step ii) is higher than the level determined at step i) or concluding that the patient will not achieve a response when the level determined at step ii) is lower than the level determined at step i).
Inventor(s):	Paris; Francois (Nantes, FR), Dubois; Nolwenn (Nantes, FR), Rio; Emmanuel (Nantes, FR), Ripoche; Natacha (Nantes, FR)
Assignee:	INSERM (INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE) (Paris, FR) UNIVERSITE DE NANTES (Nantes, FR) UNIVERSITE D\'ANGERS (Angers, FR) CENTRE NATIONAL DE LA RECHERCHE SCIENTLFIQUE (CNRS) (Paris, FR) INSTITUT DE CANCERLOGIE DE L\'OUEST--SITE RENE GAUDUCHEAU (Saint-Herblain, FR)
Application Number:	15/313,338
Patent Claims:	1. A method for treating a patient suffering from a cancer and identified as a radiotherapy responder comprising the steps of i) determining the level of ceramide in a first blood plasma or blood serum sample obtained from the patient before a first regimen of ionizing radiation, ii) treating the patient suffering from a cancer with a first and a second regimen of ionizing radiations, iii) determining the level of ceramide in a second blood plasma or blood serum sample obtained from the patient after the second regimen of ionizing radiation, iv) comparing the level determined at step i) with the level determined at step iii), thereby identifying the patient as a radiotherapy responder when the level of ceramide determined at step iii) is at least 10% higher than the level of ceramide determined at step i), and v) treating the patient suffering from a cancer and identified at step iv) as a radiotherapy responder with further regimens of ionizing radiation. 2. The method of claim 1 wherein the cancer to be treated is selected from the group consisting of primary tumors and metastatic tumors. 3. The method of claim 1 wherein the cancer is selected from the group consisting of cancer cells from the bladder, blood, bone, bone marrow, brain, breast, colon, esophagus, gastrointestine, gum, head, kidney, liver, lung, nasopharynx, neck, ovary, prostate, skin, stomach, testis, tongue, and uterus. 4. The method of claim 1 wherein the cancer is selected from the group consisting of neoplasm, malignant; carcinoma; carcinoma, undifferentiated; giant and spindle cell carcinoma; small cell carcinoma; papillary carcinoma; squamous cell carcinoma; lymphoepithelial carcinoma; basal cell carcinoma; pilomatrix carcinoma; transitional cell carcinoma; papillary transitional cell carcinoma; adenocarcinoma; gastrinoma, malignant; cholangiocarcinoma; hepatocellular carcinoma; combined hepatocellular carcinoma and cholangiocarcinoma; trabecular adenocarcinoma; adenoid cystic carcinoma; adenocarcinoma in adenomatous polyp; adenocarcinoma, familial polyposis coli; solid carcinoma; carcinoid tumor, malignant; branchiolo-alveolar adenocarcinoma; papillary adenocarcinoma; chromophobe carcinoma; acidophil carcinoma; oxyphilic adenocarcinoma; basophil carcinoma; clear cell adenocarcinoma; granular cell carcinoma; follicular adenocarcinoma; papillary and follicular adenocarcinoma; nonencapsulating sclerosing carcinoma; adrenal cortical carcinoma; endometroid carcinoma; skin appendage carcinoma; apocrine adenocarcinoma; sebaceous adenocarcinoma; ceruminous; adenocarcinoma; mucoepidermoid carcinoma; cystadenocarcinoma; papillary cystadenocarcinoma; papillary serous cystadenocarcinoma; mucinous cystadenocarcinoma; mucinous adenocarcinoma; signet ring cell carcinoma; infiltrating duct carcinoma; medullary carcinoma; lobular carcinoma; inflammatory carcinoma; paget's disease, mammary; acinar cell carcinoma; adenosquamous carcinoma; adenocarcinoma w/squamous metaplasia; thymoma, malignant; ovarian stromal tumor, malignant; thecoma, malignant; granulosa cell tumor, malignant; and roblastoma, malignant; Sertoli cell carcinoma; leydig cell tumor, malignant; lipid cell tumor, malignant; paraganglioma, malignant; extra-mammary paraganglioma, malignant; pheochromocytoma; glomangiosarcoma; malignant melanoma; amelanotic melanoma; superficial spreading melanoma; malig melanoma in giant pigmented nevus; epithelioid cell melanoma; blue nevus, malignant; sarcoma; fibrosarcoma; fibrous histiocytoma, malignant; myxosarcoma; liposarcoma; leiomyosarcoma; rhabdomyosarcoma; embryonal rhabdomyosarcoma; alveolar rhabdomyosarcoma; stromal sarcoma; mixed tumor, malignant; mullerian mixed tumor; nephroblastoma; hepatoblastoma; carcinosarcoma; mesenchymoma, malignant; brenner tumor, malignant; phyllodes tumor, malignant; synovial sarcoma; mesothelioma, malignant; dysgerminoma; embryonal carcinoma; teratoma, malignant; struma ovarii, malignant; choriocarcinoma; mesonephroma, malignant; hemangiosarcoma; hemangioendothelioma, malignant; kaposi's sarcoma; hemangiopericytoma, malignant; lymphangiosarcoma; osteosarcoma; juxtacortical osteosarcoma; chondrosarcoma; chondroblastoma, malignant; mesenchymal chondrosarcoma; giant cell tumor of bone; ewing's sarcoma; odontogenic tumor, malignant; ameloblastic odontosarcoma; ameloblastoma, malignant; ameloblastic fibrosarcoma; pinealoma, malignant; chordoma; glioma, malignant; ependymoma; astrocytoma; protoplasmic astrocytoma; fibrillary astrocytoma; astroblastoma; glioblastoma; oligodendroglioma; oligodendroblastoma; primitive neuroectodermal; cerebellar sarcoma; ganglioneuroblastoma; neuroblastoma; retinoblastoma; olfactory neurogenic tumor; meningioma, malignant; neurofibrosarcoma; neurilemmoma, malignant; granular cell tumor, malignant; malignant lymphoma; Hodgkin's disease; Hodgkin's lymphoma; paragranuloma; malignant lymphoma, small lymphocytic; malignant lymphoma, large cell, diffuse; malignant lymphoma, follicular; mycosis fungoides; other specified non-Hodgkin's lymphomas; malignant histiocytosis; multiple myeloma; mast cell sarcoma; immunoproliferative small intestinal disease; leukemia; lymphoid leukemia; plasma cell leukemia; erythroleukemia; lymphosarcoma cell leukemia; myeloid leukemia; basophilic leukemia; eosinophilic leukemia; monocytic leukemia; mast cell leukemia; megakaryoblastic leukemia; myeloid sarcoma; and hairy cell leukemia. 5. The method of claim 1 wherein the radiation therapy consists of a hypofractionated radiation therapy. 6. The method of claim 1 wherein the treatment course comprises 2, 3, 4 or 5 regimens of ionizing radiations. 7. The method of claim 1 wherein the regimen of ionizing radiations is combined with the administration of at least one chemotherapeutic agent. 8. The method of claim 7 wherein the chemotherapeutic agent is selected from the group consisting of aminoglutethimide, amsacrine, anastrozole, asparaginase, beg, bicalutamide, bleomycin, buserelin, busulfan, campothecin, capecitabine, carboplatin, carmustine, chlorambucil, cisplatin, cladribine, clodronate, colchicine, cyclophosphamide, cyproterone, cytarabine, dacarbazine, dactinomycin, daunorubicin, dienestrol, diethylstilbestrol, docetaxel, doxorubicin, epirubicin, estradiol, estramustine, etoposide, exemestane, filgrastim, fludarabine, fludrocortisone, fluorouracil, fluoxymesterone, flutamide, gemcitabine, genistein, goserelin, hydroxyurea, idarubicin, ifosfamide, imatinib, interferon, irinotecan, ironotecan, letrozole, leucovorin, leuprolide, levamisole, lomustine, mechlorethamine, medroxyprogesterone, megestrol, melphalan, mercaptopurine, mesna, methotrexate, mitomycin, mitotane, mitoxantrone, nilutamide, nocodazole, octreotide, oxaliplatin, paclitaxel, pamidronate, pentostatin, plicamycin, porfimer, procarbazine, raltitrexed, rituximab, streptozocin, suramin, tamoxifen, temozolomide, teniposide, testosterone, thioguanine, thiotepa, titanocene dichloride, topotecan, trastuzumab, tretinoin, vinblastine, vincristine, vindesine, and vinorelbine. 9. The method of claim 1 wherein the protocol of radiation therapy consists of 4 regimens of 10 Gy spread over 2 weeks at day 1, 3, 8 and 10 using combined with the administration of a dose of irinotecan injected 30 to 90 minutes before the first and third regimen of ionizing radiation. 10. The method of claim 9 wherein the second blood plasma or blood serum sample is obtained at day 3. 11. The method of claim 1 wherein the level of ceramide is determined by Ultra Performance Liquid Chromatography coupled to a mass spectrometer. 12. The method of claim 1 wherein the level of total ceramide is determined. 13. The method of claim 1 wherein the level of at least one ceramide subspecies is determined wherein the subspecies is selected from the group consisting of C16, C16:1, C18, C18:1, C20, C20:1, C22, C22:1, C24, and C24:1 ceramides. 14. The method of claim 1 wherein the level of C24 ceramides is determined. 15. The method of claim 1 wherein the level of C16, C22, C24 and C24:1 ceramide is determined.

Details for Patent 10,386,359

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
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