Drugs / Lomustine
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Lomustine

also known as CCNU · CeeNU · BCNU · Gleostine · Lomustina · lomustine (CCNU) · NSC-79037

Small molecule

Developed for
glioblastoma · central nervous system neoplasm · lymphoma · malignant glioma · medulloblastoma · anaplastic astrocytoma · brain cancer · brain neoplasm
+30 more · gliosarcoma · acute myeloid leukemia · glioma · acute leukemia of ambiguous lineage · acute lymphoblastic leukemia · adult glioblastoma · anaplastic oligodendroglioma · brain glioma · brain oligodendroglioma · central nervous system cancer · cutaneous melanoma · diffuse intrinsic pontine glioma · diffuse large B-cell lymphoma · ependymoma · IDH-wildtype glioblastoma · large-cell immunoblastic lymphoma · leptomeningeal melanoma · lung cancer · melanoma · ocular melanoma · oligodendroglioma · plasma cell myeloma · precursor lymphoblastic lymphoma/leukemia · primary central nervous system lymphoma · refractory malignant neoplasm · small cell lung carcinoma · spinal cord neoplasm · urinary bladder cancer · urothelial carcinoma · central nervous system leukemia
Investigated by
National Cancer Institute (NCI) · Children's Oncology Group · Case Comprehensive Cancer Center · Philogen S.p.A. · Emory University · European Organisation for Research and Treatment of Cancer - EORTC
+89 more · M.D. Anderson Cancer Center · Memorial Sloan Kettering Cancer Center · Alliance for Clinical Trials in Oncology · Children's Cancer and Leukaemia Group · Eastern Cooperative Oncology Group · Eli Lilly and Company · NRG Oncology · North Central Cancer Treatment Group · Pfizer · Radiation Therapy Oncology Group · SWOG Cancer Research Network · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · University Hospital Heidelberg · University Hospital, Bonn · University Medical Center Hamburg-Eppendorf · AIDS Malignancy Consortium · Aadi Bioscience, Inc. · Aarhus University Hospital · Actuate Therapeutics Inc. · Annick Desjardins · AstraZeneca · Augusta University · Bart Neyns · Beijing Tiantan Hospital · Canadian Cancer Trials Group · Celgene Corporation · Children's Hospital of Philadelphia · Cordgenics, LLC · Deutsche Kinderkrebsstiftung · Duke University · European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma · French Innovative Leukemia Organisation · Gävle Hospital · Haukeland University Hospital · Hebei Yanda Hospital · Helse Stavanger HF · Hoffmann-La Roche · Incheon St.Mary's Hospital · Indiana University · Institute of Cancer Research, United Kingdom · Istari Oncology, Inc. · Kalmar County Hospital · Karolinska Institutet · Karyopharm Therapeutics Inc · Kepler University Hospital · Ludwig-Maximilians - University of Munich · Medical Research Council · Mundipharma Research GmbH & Co KG · NCIC Clinical Trials Group · National Cancer Center, Korea · Novartis Pharmaceuticals · OHSU Knight Cancer Institute · Oliver Jonas · Oslo University Hospital · Pediatric Oncology Group · Proximagen Limited · Region Örebro County · Riverside Haematology Group · Ruhr University of Bochum · Ryhov County Hospital · Sahlgrenska University Hospital · Saint John's Cancer Institute · Skane University Hospital · Sorlandet Hospital HF · St. Olavs Hospital · Stanford University · Sundsvalls Hospital · Tactical Therapeutics, Inc. · Telix Pharmaceuticals (Innovations) Pty Limited · The Emmes Company, LLC · The Matthew Larson Foundation for Pediatric Brain Tumors · The University of Texas Health Science Center at San Antonio · Theodore S. Johnson · University Hospital Cologne · all 95 on the full record

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) GLEOSTINE 1976-08-04 fda.gov

Trials 72 · started per year

today
US approved 1976
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 03 trials
Phase 0 NCT05017610 Oct 2021 → Oct 2022 gliosarcoma Emory University Withdrawn No outcome recorded
Phase 0 NCT04135807 Mar 2020 → Jan 2028 expected anaplastic astrocytoma, anaplastic oligodendroglioma, brain oligodendroglioma, glioblastoma Oliver Jonas Recruiting No outcome recorded
Phase 0 NCT02212574 Apr 2017 → Nov 2018 medulloblastoma Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Terminated No outcome recorded
Phase 110 trials
Phase 1 NCT07145112 Oct 2025 → Jul 2027 expected glioblastoma University of California, Davis Recruiting No outcome recorded
Phase 1 NCT05304663 Jun 2022 → Dec 2024 glioblastoma Philogen S.p.A. Withdrawn No outcome recorded
Phase 1 NCT03425292 Mar 2018 → Sep 2022 malignant glioma Saint John's Cancer Institute Completed No outcome recorded
Phase 1 NCT01989052 May 2014 → Mar 2015 malignant glioma Annick Desjardins Terminated No outcome recorded
Phase 1 NCT01934361 Feb 2014 → Jul 2016 glioblastoma Novartis Pharmaceuticals Completed No outcome recorded
Phase 1 NCT01563614 Mar 2012 → Nov 2015 leptomeningeal melanoma University Hospital, Bonn Terminated No outcome recorded
Phase 1 NCT00527657 Feb 2006 → Feb 2012 brain neoplasm, melanoma M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1 NCT01682187 Dec 2005 → May 2012 glioma Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT00006024 Nov 2000 → Jan 2005 brain glioma Children's Oncology Group Completed No outcome recorded
Phase 1 NCT00005796 Feb 2000 → Jun 2003 bone marrow disorder, central nervous system neoplasm, chemotherapy-induced toxicity Indiana University Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT04573192 Feb 2021 → Mar 2025 glioblastoma Philogen S.p.A. Unknown No outcome recorded
Phase 1/2 NCT04421378 Jun 2020 → Jul 2023 glioblastoma Karyopharm Therapeutics Inc Terminated No outcome recorded
Phase 1/2 NCT02765165 Apr 2016 → Jul 2020 glioblastoma Proximagen Limited Terminated No outcome recorded
Phase 230 trials
Phase 2 NCT07632209 Jun 2026 → Jun 2028 expected small cell lung carcinoma Yayi He Not yet recruiting No outcome recorded
Phase 2 NCT07120984 Jan 2026 → Jan 2029 expected glioma Philogen S.p.A. Not yet recruiting No outcome recorded
Phase 2 NCT06336291 May 2024 → Jun 2026 overdue glioblastoma Philogen S.p.A. Active not recruiting No outcome recorded
Phase 2 NCT04863950 May 2022 → Aug 2026 overdue glioblastoma The University of Texas Health Science Center at San Antonio Recruiting No outcome recorded
Phase 2 NCT04049669 Oct 2019 → Aug 2026 overdue diffuse intrinsic pontine glioma, ependymoma, glioblastoma, medulloblastoma Theodore S. Johnson Active not recruiting No outcome recorded
Phase 2 NCT03678883 Jan 2019 → Jun 2026 overdue T lymphoblastic leukemia/lymphoma, bone cancer, breast neoplasm, colorectal neoplasm +8 Actuate Therapeutics Inc. Active not recruiting No outcome recorded
Phase 2 NCT03463265 Aug 2018 → Aug 2022 glioblastoma Aadi Bioscience, Inc. Completed No outcome recorded
Phase 2 NCT02724579 Nov 2017 → Mar 2028 expected medulloblastoma Children's Oncology Group Active not recruiting No outcome recorded
Phase 2 NCT03022578 Nov 2017 → Feb 2021 anaplastic astrocytoma, glioblastoma M.D. Anderson Cancer Center Terminated No outcome recorded
Phase 2 NCT02986178 Jun 2017 → Sep 2022 malignant glioma Istari Oncology, Inc. Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT02066220 Jun 2014 → Dec 2026 expected brain cancer University Medical Center Hamburg-Eppendorf Active not recruiting No outcome recorded
Phase 2/3 NCT00003375 Oct 1998 → Aug 2005 central nervous system neoplasm Radiation Therapy Oncology Group Completed No outcome recorded
Phase 319 trials
Phase 3 NCT07100730 Nov 2025 → Jul 2027 expected adult glioblastoma Telix Pharmaceuticals (Innovations) Pty Limited Recruiting No outcome recorded
Phase 3 NCT06419946 Feb 2025 → Dec 2031 expected IDH-wildtype glioblastoma Vastra Gotaland Region Recruiting No outcome recorded
Phase 3 NCT05095376 Mar 2022 → Feb 2026 overdue gliosarcoma NRG Oncology Active not recruiting No outcome recorded
Phase 3 NCT05331521 Apr 2021 → Mar 2033 expected oligodendroglioma University Hospital Heidelberg Recruiting No outcome recorded
Phase 3 NCT03632135 May 2018 → Jun 2022 glioblastoma Cordgenics, LLC Completed No outcome recorded
Phase 3 NCT01290939 Oct 2011 → Oct 2015 cognitive disorder, glioblastoma European Organisation for Research and Treatment of Cancer - EORTC Completed No outcome recorded
Phase 3 NCT01149109 Oct 2010 → Apr 2017 glioblastoma University Hospital, Bonn Completed No outcome recorded
Phase 3 NCT00887146 Sep 2009 → Oct 2029 expected central nervous system neoplasm Alliance for Clinical Trials in Oncology Active not recruiting No outcome recorded
Phase 3 NCT00777153 Oct 2008 → Apr 2010 glioblastoma AstraZeneca Completed No outcome recorded
Phase 3 NCT00590837 Feb 2008 → Dec 2012 acute myeloid leukemia University Hospital, Bordeaux Completed No outcome recorded
Phase not applicable5 trials
NCT02551718 Sep 2015 → Jun 2020 acute leukemia of ambiguous lineage, acute lymphoblastic leukemia University of Washington Completed No outcome recorded
NCT02333513 Feb 2015 → Dec 2017 malignant glioma Hebei Yanda Hospital Unknown No outcome recorded
NCT00317408 Apr 2004 → Feb 2014 lymphoma European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma Unknown No outcome recorded
NCT00058370 Feb 2003 → Jun 2019 central nervous system neoplasm Memorial Sloan Kettering Cancer Center Completed No outcome recorded
NCT00303810 Jan 2001 → Dec 2013 central nervous system neoplasm University Medical Center Hamburg-Eppendorf Completed No outcome recorded
Also used as a comparator or background therapy in 41 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT07629089 Background Jun 2026 → Jun 2030 expected brain cancer Megan Mantica Not yet recruiting No outcome recorded
Phase 1 NCT00503204 Background Sep 2007 → Dec 2008 brain neoplasm, glioblastoma AstraZeneca Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT03382977 Comparator Dec 2017 → Jul 2025 glioblastoma VBI Vaccines Inc. Terminated No outcome recorded
Phase 1/2 NCT00948389 Comparator Oct 2009 → May 2011 glioblastoma Bristol-Myers Squibb Terminated No outcome recorded
Phase 212 trials
Phase 2 NCT06816134 Comparator Jan 2025 → Jan 2028 expected acute lymphoblastic leukemia, acute myeloid leukemia The First Affiliated Hospital of Soochow University Recruiting No outcome recorded
Phase 2 NCT06325683 Comparator Nov 2024 → Jul 2028 glioblastoma National Cancer Institute (NCI) Suspended No outcome recorded
Phase 2 NCT06177964 Comparator Jul 2024 → Feb 2029 expected glioblastoma Darell Bigner Recruiting No outcome recorded
Phase 2 NCT04402073 Background Nov 2022 → Jun 2025 medulloblastoma European Organisation for Research and Treatment of Cancer - EORTC Terminated No outcome recorded
Phase 2 NCT04933942 Background Sep → Dec 2022 high grade astrocytic tumor European Organisation for Research and Treatment of Cancer - EORTC Withdrawn No outcome recorded
Phase 2/35 trials
Phase 2/3 NCT03970447 Comparator Jul 2019 → Jun 2028 expected glioblastoma Global Coalition for Adaptive Research Recruiting No outcome recorded
Phase 2/3 NCT03758014 Comparator Nov 2018 → Oct 2020 glioblastoma Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd Unknown No outcome recorded
Phase 2/3 NCT03025893 Comparator Aug 2018 → Jan 2022 adult glioblastoma, brain glioma Amsterdam UMC, location VUmc Unknown No outcome recorded
Phase 2/3 NCT02678975 Background Jan 2017 → Jan 2021 glioblastoma Sahlgrenska University Hospital Completed No outcome recorded
Phase 2/3 NCT02414165 Comparator Nov 2015 → May 2019 anaplastic astrocytoma, glioblastoma Tocagen Inc. Terminated No outcome recorded
Phase 316 trials
Phase 3 NCT05904119 Background Mar 2024 → Sep 2027 expected glioblastoma European Organisation for Research and Treatment of Cancer - EORTC Recruiting No outcome recorded
Phase 3 NCT05902169 Comparator Jan 2024 → Jan 2028 expected glioblastoma CarThera Recruiting No outcome recorded
Phase 3 NCT05382338 Background Feb 2023 → Dec 2029 expected childhood medulloblastoma Children's Oncology Group Recruiting No outcome recorded
Phase 3 NCT05326464 Background Oct 2022 → Feb 2025 glioblastoma University of Texas Southwestern Medical Center Completed No outcome recorded
Phase 3 NCT04702581 Background Dec 2021 → Dec 2030 expected oligodendroglioma Hospices Civils de Lyon Recruiting No outcome recorded
Phase 41 trial
Phase 4 NCT05518383 Background May 2022 → May 2025 overdue Burkitt lymphoma, primary central nervous system lymphoma, primary mediastinal large B-cell lymphoma Federal Research Institute of Pediatric Hematology, Oncology and Immunology Recruiting No outcome recorded
Phase not applicable3 trials
NCT05410301 Background Apr 2023 → Aug 2026 glioblastoma Varun Monga, MD Withdrawn No outcome recorded
NCT05667402 Comparator Jan 2023 → Dec 2025 central nervous system leukemia, disease related to hematopoietic stem cell transplant First Affiliated Hospital Xi'an Jiaotong University Unknown No outcome recorded
NCT02076152 Background Feb 2014 → Apr 2019 glioblastoma Massachusetts General Hospital Completed No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 118 sources stand behind the page.

FieldValueCited text
Known as Lomustine “The microdevices will dwell in the tumor tissue for a time window of 2-4 hours to allow time for tissue effects of the drugs (Temozolomide, Lomustine, Irinotecan, Carboplatin,...” NCT04135807
100

“Cumulative doses of chemotherapy drugs: cisplatin 210 mg/m2, lomustine (CCNU) 225 mg/m2, vincristine 18 mg/m2, cyclophosphamide 6 g/m2.” NCT02066220

“Induction therapy included idarubicin 8 mg/m2 on days 1 to 5, cytarabine 100 mg/m2 on days 1 to 7, and lomustine 200 mg/m2 on day 1.” PMID 28129526 Oct 2016

“Regimen A: Patients receive oral lomustine and cisplatin on day 0 and vincristine on days 0, 7, and 14” NCT00031590

“Day 1: Lomustine (CCNU) at 110 mg/m2 body surface orally,” NCT05331521

lomustine (CCNU), PCV or temozolomide” NCT02678975

“and Dacarbazine, Lomustine, Cisplatin” NCT05898451

“Lapatinib Lomustine Melphalan” NCT02551718

“Lapatinib, Lomustine, Mechlor” NCT02788201

NCT00527657

NCT00003101

NCT01149109

NCT02212574

NCT00761280

NCT00303810

NCT00002944

NCT00003113

NCT07100730

NCT03425292

NCT05017610

NCT00072345

NCT05095376

NCT00003114

NCT01775475

NCT01682187

NCT00989352

NCT00085735

NCT03463265

NCT00049439

NCT04402073

NCT05326464

NCT00068952

NCT00074191

NCT07145112

NCT00278278

NCT02926222

NCT00590837

NCT04573192

NCT00295815

NCT01562197

NCT07632209

NCT03149575

NCT00002840

NCT04863950

NCT00052455

NCT00005796

NCT03022578

NCT01563614

NCT01067469

NCT00317408

NCT03758014

NCT07629089

NCT02986178

NCT01290939

NCT05382338

NCT05904119

NCT00002806

NCT00100802

NCT00504660

NCT03970447

NCT06325683

NCT04049669

NCT02796261

NCT02724579

NCT00480064

NCT00006024

NCT01582269

NCT06419946

NCT00053872

NCT00274911

NCT02343406

NCT03382977

NCT01934361

NCT00276666

NCT05304663

NCT00003603

NCT06336291

NCT02765165

NCT04762069

NCT02414165

NCT00503204

NCT01989052

NCT04421378

NCT00948389

NCT02333513

NCT03025893

NCT01737346

NCT04933942

NCT03678883

NCT00003788

NCT00002875

NCT05902169

NCT06177964

NCT00777153

NCT00293280

NCT01860638

NCT00058370

NCT00003375

NCT00003929

NCT00002569

NCT05410301

Known as BCNU “Cyclophosphamide , Cytarabine, Dexamethasone, Doxorubicin hydrochloride, Etoposide, Ifosfamide, Methotrexate, Vincristine, Сarboplatine, CCNU/ BCNU, Melphalan, Idarubicin” NCT05518383
Known as CCNU “Control chemotherapy treatment will be chosen from any of the following standard-of-care chemotherapy drugs or combinations: * Carboplatin; * Irinotecan; * Etoposide; *...” NCT03632135
25

“A Phase 1/2 Dose-escalation of USL311 as Single Agent and in Combination With Lomustine (CCNU) in Subjects With Advanced Solid Tumors, With Subsequent Single Agent and...” NCT02765165

“mBuCy conditioning regimen(CCNU 250mg/m2/d -9d, Ara-C 2g/m2/d -8d; CDA 5 mg/m2/d -8d; Busulfan 3.2 mg/kg/d from -7 to -5 days; Cyclophosphamide 1.8 mg/m2/d from -4 to -3 days)” NCT06816134

“The impact of combined procarbazine, CCNU (lomustine), and vincristine (PCV) chemotherapy after radiotherapy (RT) compared with RT alone” PMID 18089866 Dec 2007

“patients received lomustine (CCNU) plus BEV (CCNU + BEV) or CCNU plus placebo (CCNU + placebo) until further disease progression (PD2).” PMID 30266892 Sep 2018

“The subjects receive modified BuCY2 conditioning regimen (Busulfan, Cytarabine, ATG, Cyclophosphamide, CCNU) before allo-HSCT.” NCT05667402

“temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle; PCV (procarbazine, CCNU, vincristine): standard regimen” NCT00431561

“The product label for lomustine (CeeNu; lomustine; CCNU) provides the following dosing information.” NCT03149575

“procarbazine, lomustine (CCNU), and vincristine (PCV) is active in patients with recurrent LGO/LGOA” PMID 12525516 Jan 2003

“Arm A, Cohort 4: nab-sirolimus + lomustine (CCNU) in patients with recurrent high grade glioma” NCT03463265

“procarbazine, lomustine (also called CCNU), and vincristine” PMID 27050206 Apr 2016

“Day 1: Lomustine (CCNU) at 110 mg/m2 body surface orally,” NCT05331521

“reinduction course including CCNU (40 mg orally on day 1)” NCT00925873

“every-six-week lomustine (CCNU) using a Bayesian model.” NCT01934361

“lomustine (CCNU), 200 mg/m2 orally at day 1” NCT00590837

“same drugs plus lomustine (CCNU), 200mg” NCT00480064

“lomustine (CCNU), PCV or temozolomide” NCT02678975

“Day 1: CCNU 110 mg/m2 orally;” NCT04702581

“Day 1: CCNU 110 mg/m2 orally” NCT02444000

“Drug: Lomustine (CCNU)” NCT04421378

“Lomustine (CCNU)” NCT00068952

NCT05518383

NCT00004259

NCT07120984

NCT00887146

NCT02076152

Known as CeeNU “Lomustine (INN), abbreviated as CCNU (original brand name (formerly available) is CeeNU, now marketed as Gleostine), is an alkylating nitrosourea compound used in chemotherapy.” NCT03758014
1

“The product label for lomustine (CeeNu; lomustine; CCNU) provides the following dosing information.” NCT03149575

Known as Gleostine “Lomustine (INN), abbreviated as CCNU (original brand name (formerly available) is CeeNU, now marketed as Gleostine), is an alkylating nitrosourea compound used in chemotherapy.” NCT03758014
Known as Lomustina ChEMBL registry synonym — accepted as the source's own label CHEMBL514
Known as lomustine (CCNU) lomustine (CCNU)NCT03463265
Known as NSC-79037 ChEMBL registry synonym — accepted as the source's own label CHEMBL514
Modality Small molecule “Lomustine is an approved oral chemotherapy that belongs to the class of drugs called alkylating agents.” NCT00777153
Route Oral oral lomustine on day 1” NCT00002569