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|Ref Type||Journal Article|
|Authors||Mohrbacher AM, Yang AS, Groshen S, Kummar S, Gutierrez ME, Kang MH, Tsao-Wei D, Reynolds CP, Newman EM, Maurer BJ|
|Title||Phase I Study of Fenretinide Delivered Intravenously in Patients with Relapsed or Refractory Hematologic Malignancies: A California Cancer Consortium Trial.|
|Journal||Clinical cancer research : an official journal of the American Association for Cancer Research|
|Date||2017 Aug 15|
|Abstract Text||Purpose: A phase I study was conducted to determine the MTD, dose-limiting toxicities (DLT), and pharmacokinetics of fenretinide delivered as an intravenous emulsion in relapsed/refractory hematologic malignancies.Experimental Design: Fenretinide (80-1,810 mg/m2/day) was administered by continuous infusion on days 1 to 5, in 21-day cycles, using an accelerated titration design.Results: Twenty-nine patients, treated with a median of three prior regimens (range, 1-7), were enrolled and received the test drug. Ninety-seven courses were completed. An MTD was reached at 1,280 mg/m2/day for 5 days. Course 1 DLTs included 6 patients with hypertriglyceridemia, 4 of whom were asymptomatic; 2 patients experienced DLT thrombocytopenia (asymptomatic). Of 11 patients with response-evaluable peripheral T-cell lymphomas, two had complete responses [CR, progression-free survival (PFS) 68+ months; unconfirmed CR, PFS 14+ months], two had unconfirmed partial responses (unconfirmed PR, PFS 5 months; unconfirmed PR, PFS 6 months), and five had stable disease (2-12 cycles). One patient with mature B-cell lymphoma had an unconfirmed PR sustained for two cycles. Steady-state plasma levels were approximately 10 mcg/mL (mid-20s μmol/L) at 640 mg/m2/day, approximately 14 mcg/mL (mid-30s μmol/L) at 905 mg/m2/day, and approximately 22 mcg/mL (mid-50s μmol/L) at 1,280 mg/m2/day.Conclusions: Intravenous fenretinide obtained significantly higher plasma levels than a previous capsule formulation, had acceptable toxicities, and evidenced antitumor activity in peripheral T-cell lymphomas. A recommended phase II dosing is 600 mg/m2 on day 1, followed by 1,200 mg/m2 on days 2 to 5, every 21 days. A registration-enabling phase II study in relapsed/refractory PTCL (ClinicalTrials.gov identifier: NCT02495415) is ongoing. Clin Cancer Res; 23(16); 4550-5. ©2017 AACR.|
|Molecular Profile||Treatment Approach|
|Gene Name||Source||Synonyms||Protein Domains||Gene Description||Gene Role|
|Therapy Name||Drugs||Efficacy Evidence||Clinical Trials|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Gene||Variant||Impact||Protein Effect||Variant Description||Associated with drug Resistance|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||hairy cell leukemia||not applicable||Fenretinide||Phase I||Actionable||In a Phase I trial, Fenretinide treatment resulted in stable disease in a patient with hairy cell leukemia (PMID: 28420721).||28420721|
|Unknown unknown||B-cell lymphoma||not applicable||Fenretinide||Phase I||Actionable||In a Phase I trial, Fenretinide treatment resulted in stable disease in a patient with B-cell lymphoma (PMID: 28420721).||28420721|
|Unknown unknown||diffuse large B-cell lymphoma||not applicable||Fenretinide||Phase I||Actionable||In a Phase I trial, Fenretinide treatment resulted in partial response in a patient with diffuse large B-cell lymphoma (PMID: 28420721).||28420721|
|Unknown unknown||peripheral T-cell lymphoma||not applicable||Fenretinide||Phase I||Actionable||In a Phase I trial, Fenretinide treatment resulted in complete response in 17% (2/11), partial response in 17% (2/11), and stable disease in 42% (5/11) of patients with peripheral T-cell lymphoma (PMID: 28420721).||28420721|
|Unknown unknown||hematologic cancer||not applicable||Fenretinide||Phase I||Actionable||In a Phase I trial, Fenretinide treatment resulted in objective response in 19% (5/26) and stable disease in 27% (7/26) of patients with hematologic cancer (PMID: 28420721).||28420721|