Results of a Phase II trial of gemcitabine, mitoxantrone, and rituximab in relapsed or refractory mantle cell lymphoma.


BACKGROUND:Gemcitabine (G) has shown activity in mantle cell lymphoma (MCL) as a single agent. The combination of mitoxantrone (M) and rituximab (R) is also active in MCL. The primary objective of this study was to determine the efficacy of G+M+R in relapsed or refractory MCL. PATIENTS AND METHODS:Sixteen patients were enrolled between April 2005 and January 2007, 88% had Stage IV MCL, Median patient age was 74 years. Patients received gemcitabine 900 mg/m(2) IV (30-60 min infusion) on Days 1 and 8, mitoxantrone 10 mg/m(2) IV (5-10 min infusion) on day 1, and rituximab 375 mg/m(2) IV on Day 1 (max 400 mg/hour) of the 21-day cycle. Patients received a median of 6 cycles (range, 1-8). RESULTS:Best responses were CR 20% (95%CI, 0, 40.2), PR 27% (95%CI, 4.3, 49.1), SD 40% (95%CI, 15.2, 64.8), and PD 13% (95%CI, 0, 30.5). Median survival and PFS have not been reached with a median follow-up of 10.7 months. The most common Grade 3-4 toxicities were neutropenia (100%), thrombocytopenia (67%), leukopenia (53%), and anemia (33%). The study was closed early due to slow accrual owing to an alternative treatment which became available at the time. CONCLUSION:The combination of G+M+R in MCL was well-tolerated with manageable toxicity using growth factors to minimize neutropenia; further studies are warranted.


Invest New Drugs


Garbo LE,Flynn PJ,MacRae MA,Rauch MA,Wang Y,Kolibaba KS




Has Abstract


2009-10-01 00:00:00












  • High dose chemotherapy with autologous marrow rescue in the treatment of resistant solid tumors.

    abstract::Toxicity in the form of marrow suppression has hampered the investigation of intensive chemotherapy as it applies to the treatment of solid tumors. The use of autologous marrow rescue to ameliorate protracted aplasia permits the application of high dose chemotherapy to the treatment of solid tumors. We review the theo...

    journal_title:Investigational new drugs

    pub_type: 杂志文章,评审


    authors: LeMaistre CF,Knight WA 3rd

    更新日期:1983-01-01 00:00:00

  • Recombinant gamma interferon in advanced breast cancer: a phase II trial.

    abstract::Fifteen patients with advanced carcinoma of the breast who had failed prior chemotherapy, were treated with recombinant gamma interferon at a dose of 2mg/m2 (1mg = 2.4 X 10(7) international units) intravenously for five consecutive days every other week. The median patient age was 51 and all patients had a performance...

    journal_title:Investigational new drugs

    pub_type: 杂志文章


    authors: Muss HB,Caponera M,Zekan PJ,Jackson DV Jr,Stuart JJ,Richards F,Cooper MR,Levin EA,Reich SD,Capizzi RL

    更新日期:1986-01-01 00:00:00

  • Cytotoxicity of withaferin A in glioblastomas involves induction of an oxidative stress-mediated heat shock response while altering Akt/mTOR and MAPK signaling pathways.

    abstract::Withaferin A (WA), a steroidal lactone derived from the plant Vassobia breviflora, has been reported to have anti-proliferative, pro-apoptotic, and anti-angiogenic properties against cancer growth. In this study, we identified several key underlying mechanisms of anticancer action of WA in glioblastoma cells. WA was f...

    journal_title:Investigational new drugs

    pub_type: 杂志文章


    authors: Grogan PT,Sleder KD,Samadi AK,Zhang H,Timmermann BN,Cohen MS

    更新日期:2013-06-01 00:00:00

  • Phase II evaluation of dianhydrogalactitol in the treatment of advanced non-squamous cervical carcinoma. A Gynecologic Oncology Group study.

    abstract::In an on-going Phase II evaluation, dianhydrogalactitol (NSC 132313) was administered intravenously to 28 patients with advanced or recurrent non-squamous cell carcinoma of the cervix. The initial dosage was 60 mg/m2/wk with escalation to 75 mg/m2/wk if there were no adverse effects. Twenty-seven patients were evaluab...

    journal_title:Investigational new drugs

    pub_type: 杂志文章


    authors: Stehman FB,Blessing JA,Homesley HD,Currie JL,Yordan EL

    更新日期:1984-01-01 00:00:00

  • Artemisinin reduces human melanoma cell migration by down-regulating alpha V beta 3 integrin and reducing metalloproteinase 2 production.

    abstract::Artemisinin and its derivatives are well known antimalarial drugs, particularly useful after resistance to traditional antimalarial pharmaceuticals has started to occur in Plasmodium falciparum. In recent years, anticancer activity of artemisinin has been reported both in vitro and in vivo. Artemisinin has inhibitory ...

    journal_title:Investigational new drugs

    pub_type: 杂志文章


    authors: Buommino E,Baroni A,Canozo N,Petrazzuolo M,Nicoletti R,Vozza A,Tufano MA

    更新日期:2009-10-01 00:00:00

  • Phase II trial of 5 day continuous intravenous infusion of 6-thioguanine in patients with recurrent and metastatic squamous cell carcinoma of the head and neck.

    abstract::Fifteen patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck received a 5 day continuous I.V. infusion of 6-thioguanine repeated every five weeks. Dose limiting toxicity was primarily hematological with grade III/IV leucopenia and thrombocytopenia seen in seven patients. Nausea and vo...

    journal_title:Investigational new drugs

    pub_type: 临床试验,杂志文章


    authors: Kruter F,Eisenberger M,Sinibaldi V,Engstrom C,Jacobs M,Abrams J,Belani C,Gray W,Krasnow S

    更新日期:1992-07-01 00:00:00

  • Biochemical modulation of 5-fluorouacil through dihydropyrimidine dehydrogenase inhibition: a Southwest Oncology Group phase II trial of eniluracil and 5-fluorouracil in advanced resistant colorectal cancer.

    abstract:PURPOSE:To investigate the hypothesis that a systemic agent designed to inhibit dihydropyrimidine dehydrogenase (DPD), the first enzyme in the fluoropyrimidine degradative pathway, could improve the effective amount of 5-fluorouracil (5-FU) delivered to a tumor resulting in enhanced response. PATIENTS AND METHODS:Elig...

    journal_title:Investigational new drugs

    pub_type: 临床试验,杂志文章,多中心研究


    authors: Leichman CG,Chansky K,Macdonald JS,Doukas MA,Budd GT,Giguere JK,Abbruzzese JL,Southwest Oncology Group.

    更新日期:2002-11-01 00:00:00

  • A phase I, dose-escalation study of PF-06650808, an anti-Notch3 antibody-drug conjugate, in patients with breast cancer and other advanced solid tumors.

    abstract::Background PF-06650808 is a novel anti-Notch3 antibody-drug conjugate (ADC) able to deliver an auristatin-based cytotoxic payload to target cells. In this first-in-human, dose-finding, phase I study (NCT02129205), we investigated safety, pharmacokinetics, immunogenicity, and preliminary antitumor activity of single-ag...

    journal_title:Investigational new drugs

    pub_type: 杂志文章,多中心研究,随机对照试验


    authors: Rosen LS,Wesolowski R,Baffa R,Liao KH,Hua SY,Gibson BL,Pirie-Shepherd S,Tolcher AW

    更新日期:2020-02-01 00:00:00

  • Prolonged infusion gemcitabine: a clinical phase I study at low- (300 mg/m2) and high-dose (875 mg/m2) levels.

    abstract::Gemcitabine (GEM) is a novel nucleoside analogue with a unique mechanism of action. Preliminary studies have shown a mild, schedule-dependent toxic profile with a broad range of MTDs and promising antitumor activity in various solid tumors. This phase I study describes the infusion length-effect relationships of low- ...

    journal_title:Investigational new drugs

    pub_type: 临床试验,杂志文章


    authors: Pollera CF,Ceribelli A,Crecco M,Oliva C,Calabresi F

    更新日期:1997-01-01 00:00:00

  • A pilot study for the early assessment of the effects of BMS-754807 plus gefitinib in an H292 tumor model by [(18)F]fluorothymidine-positron emission tomography.

    abstract::BMS-754807 is an inhibitor of insulin-like growth factor-1 receptor (IGF-1R) and insulin receptor that also represses aurora kinase. Cancers that express high levels of IGF-1/IGF-1R are sensitive to BMS-754807; however, it shows limited efficacy in non-small cell lung cancer (NSCLC) in which IGF-1R-driven signals may ...

    journal_title:Investigational new drugs

    pub_type: 杂志文章


    authors: Lee SJ,Kim EJ,Lee HJ,Kim SY,Oh SJ,Ryu JS,Moon DH,Ahn JH,Kim SW

    更新日期:2013-06-01 00:00:00

  • A phase I safety and pharmacokinetic study of ABT-263 in combination with carboplatin/paclitaxel in the treatment of patients with solid tumors.

    abstract::Bcl-2 family proteins are the key regulators of the intrinsic apoptotic pathway, controlling the point-of no-return and setting the threshold to engage the death machinery in response to chemical damage. Bcl-2 proteins have emerged as attractive targets for anti-cancer drug development. Navitoclax is a selective, pote...

    journal_title:Investigational new drugs

    pub_type: 杂志文章


    authors: Vlahovic G,Karantza V,Wang D,Cosgrove D,Rudersdorf N,Yang J,Xiong H,Busman T,Mabry M

    更新日期:2014-10-01 00:00:00

  • Phase I dose-finding and pharmacokinetic trial of orally administered indibulin (D-24851) to patients with solid tumors.

    abstract::Indibulin is a synthetic small molecule which antitumor activity is based upon destabilization of microtubules. The primary study objectives were to determine the impact of fasted and fed condition on pharmacokinetic parameters, as well as the maximum tolerated dose of the oral drinking solution of indibulin administe...

    journal_title:Investigational new drugs

    pub_type: 杂志文章,多中心研究,随机对照试验


    authors: Kuppens IE,Witteveen PO,Schot M,Schuessler VM,Daehling A,Beijnen JH,Voest EE,Schellens JH

    更新日期:2007-06-01 00:00:00

  • Enhanced oncolysis mediated by Coxsackievirus A21 in combination with doxorubicin hydrochloride.

    abstract::Virotherapy is an emerging strategy for the treatment of cancer that utilizes both replication-competent and genetically modified viruses to selectively kill tumor cells. We have previously shown that Coxsackievirus A21 (CVA21), a common-cold producing enterovirus, is an effective oncolytic agent against human melanom...

    journal_title:Investigational new drugs

    pub_type: 杂志文章


    authors: Skelding KA,Barry RD,Shafren DR

    更新日期:2012-04-01 00:00:00

  • VM-26 in colorectal carcinoma: a Southwest Oncology Group study.

    abstract::In this multi-institutional phase II study, VM-26 or Teniposide was administered to forty-two patients with advanced colorectal cancer. Patients were initially treated at 60 mg/M2 daily for 5 days with dose adjustments depending on toxicity. One complete response and one partial response were observed lasting six and ...

    journal_title:Investigational new drugs

    pub_type: 临床试验,杂志文章,多中心研究


    authors: Oishi N,Fleming TR,Laufman L,Ungerleider JS,Natale RB,Einstein AB Jr,Von Hoff DD,Macdonald JS

    更新日期:1990-02-01 00:00:00

  • Phase II trial of uracil/tegafur (UFT) plus leucovorin in patients with advanced hepatocellular carcinoma.

    abstract:UNLABELLED:Although UFT 300 mg/m2/day and leucovorin 90 mg/day administered orally in divided doses administered every 8 hours for 28 days repeated every 35 days could be administered safely to patients with advanced hepatomas and good performance status, this combination and schedule has limited activity in treating a...

    journal_title:Investigational new drugs

    pub_type: 临床试验,杂志文章


    authors: Mani S,Schiano T,Garcia JC,Ansari RH,Samuels B,Sciortino DF,Tembe S,Shulman KL,Baker A,Benner SE,Vokes EE

    更新日期:1998-01-01 00:00:00

  • Mononuclear cell polyamine content associated with myeloid maturation in patients with leukemia during administration of polyamine inhibitors.

    abstract::Fourteen patients with acute leukemia in relapse were treated with difluoromethylornithine (DFMO) alone or in combination with methylglyoxal-bis(guanylhydrazone) (MGBG) as part of Phase I studies. Five patients included in the trial exhibited morphologic evidence of cellular differentiation during the course of treatm...

    journal_title:Investigational new drugs

    pub_type: 杂志文章


    authors: Maddox AM,Keating MJ,Freireich EJ,Haddox MK

    更新日期:1989-07-01 00:00:00

  • Effects of the tumor vasculature targeting agent NGR-TNF on the tumor microenvironment in murine lymphomas.

    abstract::TNF-alpha may improve drug delivery to tumors by alteration of vascular permeability. However, toxicity precludes its systemic administration in patients. NGR-TNF comprises TNF coupled to the peptide CNGRC, which is a ligand for CD13. CD13 is expressed on tumor vasculature. Therefore, to assess the efficacy of NGR-TNF...

    journal_title:Investigational new drugs

    pub_type: 杂志文章


    authors: van Laarhoven HW,Gambarota G,Heerschap A,Lok J,Verhagen I,Corti A,Toma S,Gallo Stampino C,van der Kogel A,Punt CJ

    更新日期:2006-01-01 00:00:00

  • Preclinical antitumor activity of XK469 (NSC 656889).

    abstract::XK469 (NSC 656889) is a water-soluble member of the novel quinoxaline family of antitumor agents. In vitro, XK469 demonstrated selective cytotoxicity for several murine solid tumors including colorectal and mammary adenocarcinoma cell lines, when compared to both leukemia and normal epithelial cells. In vivo, XK469 wa...

    journal_title:Investigational new drugs

    pub_type: 杂志文章


    authors: LoRusso PM,Parchment R,Demchik L,Knight J,Polin L,Dzubow J,Behrens C,Harrison B,Trainor G,Corbett TH

    更新日期:1998-01-01 00:00:00

  • Feasibility of olanzapine, multi acting receptor targeted antipsychotic agent, for the prevention of emesis caused by continuous cisplatin- or ifosfamide-based chemotherapy.

    abstract::Background To determine the feasibility and efficacy of olanzapine, which is approved by the Pharmaceuticals and Medical Devices Agency as multi acting receptor targeted antipsychotic agent of the thienobenzodiazepine class, for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients undergoing conti...

    journal_title:Investigational new drugs

    pub_type: 临床试验,杂志文章


    authors: Bun S,Yonemori K,Akagi T,Noguchi E,Shimoi T,Shimomura A,Yunokawa M,Shimizu C,Fujiwara Y,Makino Y,Hayashi Y,Tamura K

    更新日期:2018-02-01 00:00:00

  • Phase I trial of Adozelesin using the treatment schedule of daily x5 every 3 weeks.

    abstract::CC-1065 is a unique alkylating agent that preferentially binds in the minor groove of double-stranded DNA at adenine-thymine-rich sites. Although it has broad antitumor activity in preclinical models its development was discontinued because of deaths observed during preclinical toxicology studies. Adozelesin is a pote...

    journal_title:Investigational new drugs

    pub_type: 临床试验,杂志文章


    authors: Foster BJ,LoRusso PM,Poplin E,Zalupski M,Valdivieso M,Wozniak A,Flaherty L,Kasunic DA,Earhart RH,Baker LH

    更新日期:1996-01-01 00:00:00

  • Inhibitory effect of tea polyphenols on hepatic preneoplastic foci in Wistar rats.

    abstract::Tea (Camellia sinensis) is one of the most widely used beverages worldwide and tea consumption has been shown to have an inverse correlation to the incidence of human cancers in epidemiological and experimental studies. In the present study, the protective effects of green tea polyphenols (GTP) and black tea polypheno...

    journal_title:Investigational new drugs

    pub_type: 杂志文章


    authors: Srivastava S,Singh M,Roy P,Prasad S,George J,Shukla Y

    更新日期:2009-12-01 00:00:00

  • First-line combination chemotherapy with mitoxantrone and cyclophosphamide in advanced breast cancer.

    abstract::In this study, 30 evaluable patients with advanced carcinoma of the breast were treated with cyclophosphamide 600 mg/m2 i.v. followed one day later with mitoxantrone (Novantrone; dihydroxyanthracenedione) 16 mg/m2 i.v. Drug treatment was repeated every 3-4 weeks, for a maximum of 12 cycles. The overall response rate w...

    journal_title:Investigational new drugs

    pub_type: 杂志文章


    authors: Periti P,della Cuna GR,Pannuti F,Mazzei T,Preti P,Martoni A,Mini E

    更新日期:1985-01-01 00:00:00

  • A study of a different dose-intense infusion schedule of phenylacetate in patients with recurrent primary brain tumors consortium report.

    abstract:PURPOSE:To compare two different infusion schedules of phenylacetate (PA) in patients with primary brain tumors and to assess the feasibility of the administration in a multi-institutional setting. PATIENTS AND METHODS:Adult patients with recurrent primary brain tumors were treated with PA on two different schedules. ...

    journal_title:Investigational new drugs

    pub_type: 杂志文章


    authors: Chang SM,Kuhn JG,Ian Robins H,Clifford Schold S,Spence AM,Berger MS,Mehta MP,Pollack I,Gilbert M,Prados MD

    更新日期:2003-11-01 00:00:00

  • Structure-activity relationships between the Aconitum C20-diterpenoid alkaloid derivatives and the growth suppressive activities of Non-Hodgkin's lymphoma Raji cells and human hematopoietic stem/progenitor cells.

    abstract::The anti-tumor properties of novel derivatives prepared from Aconitum C(20)-diterpenoid alkaloid, which show the least toxicity among the Aconitum alkaloids, were investigated in the Non-Hodgkin's lymphoma cell line Raji cells. Two novel Aconitum C(20)-diterpenoid alkaloid derivatives, 11-m-Trifluorometylbenzoyl (Mb)-...

    journal_title:Investigational new drugs

    pub_type: 杂志文章


    authors: Hazawa M,Takahashi K,Wada K,Mori T,Kawahara N,Kashiwakura I

    更新日期:2011-02-01 00:00:00

  • Phase Ia/Ib study of the pan-class I PI3K inhibitor pictilisib (GDC-0941) administered as a single agent in Japanese patients with solid tumors and in combination in Japanese patients with non-squamous non-small cell lung cancer.

    abstract::Pictilisib (GDC-0941) is an oral class I phosphatidylinositol-3-phosphate kinase inhibitor. This phase Ia/Ib study investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of pictilisib in monotherapy or in combination with carboplatin-paclitaxel and bevacizumab (CP + BEV) in Japanese patients wit...

    journal_title:Investigational new drugs

    pub_type: 杂志文章,多中心研究


    authors: Yamamoto N,Fujiwara Y,Tamura K,Kondo S,Iwasa S,Tanabe Y,Horiike A,Yanagitani N,Kitazono S,Inatani M,Tanaka J,Nishio M

    更新日期:2017-02-01 00:00:00

  • Recombinant human lactoferrin carrying humanized glycosylation exhibits antileukemia selective cytotoxicity, microfilament disruption, cell cycle arrest, and apoptosis activities.

    abstract::Lactoferrin has gained extensive attention due to its ample biological properties. In this study, recombinant human lactoferrin carrying humanized glycosylation (rhLf-h-glycan) expressed in the yeast Pichia pastoris SuperMan5, which is genetically glycoengineered to efficiently produce functional humanized glycoprotei...

    journal_title:Investigational new drugs

    pub_type: 杂志文章


    authors: Nakamura-Bencomo S,Gutierrez DA,Robles-Escajeda E,Iglesias-Figueroa B,Siqueiros-Cendón TS,Espinoza-Sánchez EA,Arévalo-Gallegos S,Aguilera RJ,Rascón-Cruz Q,Varela-Ramirez A

    更新日期:2020-10-16 00:00:00

  • Absolute and relative activities of platinum-complexes on human tumors as evaluated by an antimetabolic in vitro assay.

    abstract::An in vitro assay, which evaluates drug effect on 3H-thymidine incorporation, was used to investigate the absolute and relative activities of cisplatin (DDP), carboplatin (CBDCA) and iproplatin (CHIP) on 317 specimens from untreated tumors, including breast and ovarian cancers and malignant melanomas. Similar activiti...

    journal_title:Investigational new drugs

    pub_type: 杂志文章


    authors: Daidone MG,Silvestrini R,Zaffaroni N,Grignolio E,Landoni F

    更新日期:1987-01-01 00:00:00

  • Phase I/II study of erlotinib plus S-1 for patients with previously treated non-small cell lung cancer: Thoracic Oncology Research Group (TORG) 0808/0913.

    abstract::Introduction In preclinical data, the combination therapy with S-1 and epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) had a synergistic antitumor effect on non-small cell lung cancer (NSCLC), regardless of the EGFR mutation status. Patients and Methods Patients with previously treated NSCLC an...

    journal_title:Investigational new drugs

    pub_type: 杂志文章


    authors: Nakahara Y,Shimokawa T,Misumi Y,Nogami N,Shinkai T,Seki N,Hosomi Y,Hida N,Okamoto H

    更新日期:2020-08-15 00:00:00

  • Phase I study of TAS-102 and irinotecan combination therapy in Japanese patients with advanced colorectal cancer.

    abstract:BACKGROUND:TAS-102 is a nucleoside antitumor agent consisting of trifluridine (FTD) and tipiracil hydrochloride (TPI). We investigated the recommended dose (RD) of TAS-102 plus irinotecan for metastatic colorectal cancer refractory to 5-fluorouracil (5-FU) and oxaliplatin. METHODS:This study was used a escalated dose ...

    journal_title:Investigational new drugs

    pub_type: 杂志文章


    authors: Doi T,Yoshino T,Fuse N,Boku N,Yamazaki K,Koizumi W,Shimada K,Takinishi Y,Ohtsu A

    更新日期:2015-10-01 00:00:00

  • A phase I trial of the bombesin/gastrin-releasing peptide (BN/GRP) antagonist RC3095 in patients with advanced solid malignancies.

    abstract::Bombesin/gastrin-releasing peptides (BN/GRP) were shown to bind selectively to cell surface receptors, stimulating the growth of various types of malignancies in murine and human models. The novel BN/GRP synthetic receptor antagonist, RC-3095, was able to produce long-lasting tumor regressions in murine and human tumo...

    journal_title:Investigational new drugs

    pub_type: 杂志文章


    authors: Schwartsmann G,DiLeone LP,Horowitz M,Schunemann D,Cancella A,Pereira AS,Richter M,Souza F,da Rocha AB,Souza FH,Pohlmann P,De Nucci G

    更新日期:2006-09-01 00:00:00