NCT0. 17. 11. 55. Clinical Trial - National Cancer Institute. Basic Trial Information. Phase. Type. Status. Age. Trial IDs. Phase IBiomarker/Laboratory analysis, Treatment. Active. 21 and under. NANT N2. 01. 1- 0. NCI- 2. 01. 2- 0. CDR0. 00. 07. 41. N2. 01. 1- 0. 4, NANT 1. ![]() Improving Outcome for Children with High-Risk Neuroblastoma. The trial’s main objective was to determine. PNANT N2. 01. 1- 0. Drugs used in chemotherapy, such as lenalidomide and isotretinoin, work in different wants to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone. Solid Tumor Studies- Addison Jo Blair Cancer Care. ANBL0032 is a clinical trial seeking to determine the effectiveness of chemotherapy with or without. University of Miami Health System offers healthcare services from South Florida's premier doctors and hospitals by combining patient care, research and education. Monoclonal antibodies, such as dinutuximab, may interfere with the ability of tumor cells to grow and spread. Giving more than one drug (combination chemotherapy) together with dinutuximab therapy may kill more tumor cells. Further Study Information. PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2. D) of lenalidomide in combination with fixed doses of ch. II. To define the toxicities of lenalidomide administered in combination with ch. III. To describe the differences in immune function modulation between . To determine the pharmacokinetics of lenalidomide given in this combination regimen. II. To determine the steady state pharmacokinetics of isotretinoin (day 2. III. To measure peak and trough levels of ch. IL- 2) and granulocyte- macrophage colony- stimulating factor (GM- CSF). IV. To describe the immunological effects of lenalidomide (T cells, natural killer . To define the incidence and titers of human anti- chimeric antibody (HACA) on this regimen. VI. To describe, within the context of a phase I study, the response rate to lenalidomide combined with ch. VII. To summarize, within the context of a phase I study, the event- free survival of patients with recurrent/refractory neuroblastoma or in complete response (CR) after progressing, and who are treated with lenalidomide combined with ch. VIII. To determine, within the context of a phase I study, if killer- cell immunoglobulin- like receptor (KIR) receptor- ligand mismatch or specific Fc gamma receptor (Fc gamma R) alleles are associated with anti- tumor response. IX. To quantify neuroblastoma tumor cell . To compare the toxicities of this regimen with the historical toxicity data from the Children's Oncology Group (COG) ANBL0. ANBL0. 93. 1 studies of ch. IL- 2, GM- CSF and isotretinoin. XI. To describe the tolerability and ability to give full doses of ch. Treatment repeats every 2. After completion of study treatment, patients are followed up periodically. Eligibility Criteria. Inclusion Criteria: Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines. Patients must have high- risk neuroblastoma. Patients must have at least ONE of the following: Recurrent/progressive disease at any time prior to enrollment - regardless of response to frontline therapy. Refractory disease: persistent sites of disease (after less than a partial response to frontline therapy, following a minimum of 4 cycles of induction therapy) AND patient has never had a relapse/progression. Persistent disease: persistent disease after achieving at least a partial response to frontline therapy after a minimum of 4 cycles of induction therapy and patient has never had a relapse/progression. Patients must have at least ONE of the following (lesions may have received prior radiation therapy as long as they meet the other criteria listed below): Bone disease. At least one metaiodobenzylguanidine (MIBG) avid bone site or diffuse MIBG uptake*** For recurrent/progressive or refractory disease a biopsy is not required regardless of number of MIBG avid lesions*** For persistent disease, if patient has only 1 or 2 MIBG avid lesions OR a Curie score of 1- 2, then biopsy confirmation of neuroblastoma and/or ganglioneuroblastoma in at least one site present at the time of enrollment (bone marrow, bone, or soft tissue) is required to be obtained at any time point prior to enrollment and two weeks subsequent to most recent prior therapy; if a patient has 3 or more MIBG avid lesions OR a Curie score of > = 3 then no biopsy is required for eligibility. If a tumor is known to be MIBG non- avid, then a patient must have at least one fludeoxyglucose (FDG)- positron emission tomography (PET) avid bone site present at the time of enrollment with biopsy confirmation of neuroblastoma and/or ganglioneuroblastoma obtained at any time prior to enrollment and two weeks subsequent to most recent prior therapy. Any amount of neuroblastoma tumor cells in the bone marrow based on routine morphology (with or without immunocytochemistry) in at least one sample from bilateral aspirates and biopsies. At least one soft tissue lesion that meets the criteria for a TARGET lesion as defined by: SIZE: Lesion can be accurately measured in at least one dimension with a longest diameter > = 1. In addition to size, a lesion needs to meet ONE of the following criteria: *** MIBG avid; for patients with persistent disease only: if a patient has only 1 or 2 MIBG avid lesions OR a Curie score of 1- 2, then biopsy confirmation of neuroblastoma and/or ganglioneuroblastoma in at least one site present at time of enrollment (either bone marrow, bone and/or soft tissue) is required to be obtained at any time point prior to enrollment and at least two weeks subsequent to most recent prior therapy; if a patient has 3 or more MIBG avid lesions OR a Curie score of > = 3 then no biopsy is required for eligibility*** FDG- PET avid (only if tumor is known to be MIBG non- avid); these patients must have had a biopsy confirming neuroblastoma and/or ganglioneuroblastoma in at least one FDG- PET avid site present at the time of enrollment done prior to enrollment and at least two weeks subsequent to the most recent prior therapy*** Non- avid lesion (both MIBG and FDG- PET non- avid); these patients must have had a biopsy confirming neuroblastoma and/or ganglioneuroblastoma in at least one non- avid lesion present at the time of enrollment done prior to enrollment and at least two weeks subsequent to the most recent prior therapy. Patients with prior progressive disease who do not meet criteria above, are eligible as long as they have not been off treatment for > 3 months prior to enrollment on NANT 2. Patients must have a life expectancy of at least 6 weeks. Lansky (=< 1. 6 years) or Karnofsky (> 1. Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study enrollment. Patients must not have received the therapies indicated below for the specified time period prior to the first day of administration of protocol therapy on this study. Myelosuppressive chemotherapy: must have received last dose at least 2 weeks prior to protocol therapy; this includes cytotoxic agents given on a low dose metronomic regimen. Biologic (anti- neoplastic agent) (includes retinoids): must have received last dose at least 7 days prior to protocol therapy. Monoclonal antibodies: must have received last dose at least 7 days or 3 half- lives, whichever is longer, prior to protocol therapy. Radiation: Patients must not have received radiation (small port) for a minimum of two weeks prior to protocol therapy. Except for patients with a history of progressive disease, patients whose only site(s) of disease have been radiated are eligible if at least one lesion meets at least one of the criteria listed in sites of disease above. A minimum of 1. 2 weeks prior to start of protocol therapy is required following large field radiation therapy (i. Accutane, Sotret) but are eligible if they can take an alternate preparation without paraben; (applicable only for entry onto dose levels receiving isotretinoin)Patients with a history of venous or arterial thrombosis personally before the age of 4. Patients with a history of prior central nervous system (CNS) metastases or skull lesions with intracranial extension will be required to have a head computed tomography (CT) or magnetic resonance imaging (MRI) at study entry demonstrating no active CNS metastases; patients with skull metastases with associated intracranial soft tissue masses will remain eligible. Inability to swallow lenalidomide capsules whole; capsules of 1. Patient declines participation in NANT 2. NANT 2. 00. 4- 0. NANT Operations Center. Trial Lead Organizations / Sponsors / Collaborators. National Cancer Institute. National Cancer Institute. Araz Marachelian, Principal Investigator. Trial Sites. U. S. A. California. Los Angeles Children's Hospital Los Angeles. Araz Marachelian. Ph: 3. 23- 3. 61- 8. Email: amarachelian@chla. Araz Marachelian. Principal Investigator. Palo Alto Lucile Packard Children's Hospital Stanford University. Neyssa Maria Marina. Ph: 6. 50- 7. 23- 5. Email: nmarina@stanford. Neyssa Maria Marina. Principal Investigator. San Francisco UCSF Medical Center- Parnassus. Katherine Kurshan Matthay. Ph: 4. 15- 4. 76- 0. Email: matthayk@peds. Katherine Kurshan Matthay. Principal Investigator. Georgia. Atlanta Children's Healthcare of Atlanta - Egleston. Kelly C. Goldsmith. Ph: 4. 04- 7. 27- 2. Email: kgoldsm@emory. Kelly C. Goldsmith. Principal Investigator. Illinois. Chicago University of Chicago Comer Children's Hospital. Susan Lerner Cohn. Ph: 7. 73- 7. 02- 2. Email: scohn@peds. Susan Lerner Cohn. Principal Investigator. Michigan. Ann Arbor C S Mott Children's Hospital. Gregory A. Yanik. Ph: 7. 34- 7. 46- 3. Email: gyanik@umich. Gregory A. Yanik. Principal Investigator. New York. New York Memorial Sloan- Kettering Cancer Center. Stephen S. Roberts. Ph: 2. 12- 6. 39- 4. Email: robertss@mskcc. Stephen S. Roberts. Neuroblastoma Myeloablative Therapy & Autologous Stem Cell Rescue. Clinical Trial. Offered by: Nemours. Locations: Jacksonville, FL, Pensacola, FL.
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March 2018
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