scholarly journals High-Dose Radioimmunotherapy Combined with Fixed, Low-Dose Paclitaxel in Metastatic Prostate and Breast Cancer by Using a MUC-1 Monoclonal Antibody, m170, Linked to Indium-111/Yttrium-90 via a Cathepsin Cleavable Linker with Cyclosporine to Prevent Human Anti-mouse Antibody

2005 ◽  
Vol 11 (16) ◽  
pp. 5920-5927 ◽  
Author(s):  
Carol M. Richman ◽  
Sally J. DeNardo ◽  
Robert T. O'Donnell ◽  
Aina Yuan ◽  
Sui Shen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Monoclonal Antibody ◽  
Low Dose ◽  
High Dose ◽  
Indium 111 ◽  
Mouse Antibody ◽  
Yttrium 90 ◽  
Human Anti Mouse Antibody

Cisplatin and VP16 in Metastatic Breast Carcinoma as a Third-Line Chemotherapy: A Randomized Study Comparing Low versus High Doses of Cisplatin

1995 ◽  
Vol 81 (4) ◽  
pp. 241-244 ◽  
Author(s):  
Guido Ceci ◽  
Giancarlo Bisagni ◽  
Giorgio Cocconi ◽  
Carmelina Rodinò ◽  
Virginio Belsanti ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Low Dose ◽  
Objective Response ◽  
Metastatic Breast ◽  
Advanced Breast ◽  
High Dose ◽  
Severe Toxicity ◽  
Third Line ◽  
Line Chemotherapy

Aims and background The study was designed to define the activity of the combination of cisplatin and etoposide as third-line chemotherapy for advanced breast cancer and to investigate the role of the dosage of cisplatin on the effectiveness of the combination. Methods Ninety-five eligible patients with advanced breast cancer who had failed or relapsed on two previous lines of chemotherapy were randomized to receive cisplatin at a high dose (100 mg/m2 i.v. day 1, arm A) or a low dose (60 mg/m2 day 1, arm B), combined with etoposide (100 mg/m2 i.v. days 4, 6 and 8). Cycles were repeated every 3 weeks. Results Of the 78 patients evaluable for response (39 in arm A and 39 in arm B), 9 (12%) showed complete or partial response, 5 (13%) in the high-dose arm and 4 (10%) in the low-dose arm. One complete response was seen in the high-dose arm and none in the low-dose arm. The only 2 patients with brain involvement showed an objective response (one CR in arm A and one PR in arm B). Median time to progression was 14 weeks in arm A and 10 weeks in arm B, median duration of remission 28 and 34 weeks, and survival 36 and 35 weeks, respectively. The differences were not significant. As expected, the patients in the high-dose arm experienced more severe toxicity. One toxic death was observed in each arm due to sepsis in agranulocytosis. The difference was statistically significant regarding nausea and vomiting. Neurotoxicity and ototoxicity were not relevant problems in this patient setting. Conclusions Considering the very poor prognostic factors presented by these patients, the combination showed a certain activity, and further evaluation in earlier stages of disease is warranted. A particular responsiveness on brain metastases is suggested. The dose of cisplatin was not proven to be of significant importance.

Treatment of Steroid-Refractory Acute Graft Versus Host Disease with Low Dose Combination Monoclonal Antibody Therapy: A Pilot Study.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 1255-1255
Author(s):  
John J. Moore ◽  
Amanda Johnston ◽  
Ma D.F. David ◽  
Milliken Sam ◽  
Fay Keith ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Low Dose ◽  
Antibody Therapy ◽  
Infectious Complications ◽  
High Dose ◽  
Monoclonal Antibody Therapy ◽  
Graft Versus Host ◽  
Dose Combination ◽  
Steroid Refractory ◽  
Acute Graft

Abstract Severe (Grade III–IV) acute graft versus host disease (aGVHD) is a serious complication of allogeneic haemopoietic stem cell transplantation. Patients not responding to high dose corticosteroids have a very poor prognosis (60–90% mortality). Previous second line agents, such as anti-thymocyte globulin, have had limited success in controlling steroid-refractory aGVHD. Recently monoclonal antibodies that target cytokines (TNF and IL-2) have been trialled, with several case series reporting responses to high dose infliximab (10mg/kg, x1-9 doses) and daclizumab (1mg/kg, x5-8 doses), alone or in combination. Here we report the results of a pilot study using reduced-dose infliximab and daclizumab, along with strict antimicrobial prophylaxis, for refractory aGVHD. The aim was to maintain the efficacy of monoclonal antibody therapy whilst reducing the infectious complications seen in previous series. Since May 2003 we have treated 10 allogeneic transplant patients with one or both of the monoclonal antibodies. All had failed a minimum of 3 days methylprednisolone 2mg/kg/day, started a median of 35 days post-transplant. The first four patients received infliximab 10mg/kg, x2-3 doses. Two of four had a complete response with one patient alive 15 months after antibody treatment. The remaining three died of opportunistic infections. Following this study, a second cohort of patients (n=6) were given low dose, combination therapy (infliximab 5mg/kg, x2 doses and daclizumab 1mg/kg, x4 doses). 5/6 patients had complete resolution of aGVHD and 5/6 are alive at a median of 130 days post-treatment. One patient died of MRSA pneumonia despite resolution of GVHD. The remaining 5 patients have had minimal and manageable infectious complications whilst on strict prophylactic regimens. In conclusion, low dose combination monoclonal antibody therapy appears to be a promising and safe treatment for refractory aGVHD.

Phase I Trial of Yttrium-90—Labeled Anti—Prostate-Specific Membrane Antigen Monoclonal Antibody J591 for Androgen-Independent Prostate Cancer

2004 ◽  
Vol 22 (13) ◽  
pp. 2522-2531 ◽  
Author(s):  
Matthew I. Milowsky ◽  
David M. Nanus ◽  
Lale Kostakoglu ◽  
Shankar Vallabhajosula ◽  
Stanley J. Goldsmith ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Monoclonal Antibody ◽  
Specific Antigen ◽  
Maximum Tolerated Dose ◽  
Prostate Specific Membrane Antigen ◽  
Life Threatening ◽  
Indium 111 ◽  
Specific Membrane ◽  
Yttrium 90 ◽  
Androgen Independent

Purpose To determine the maximum-tolerated dose (MTD), toxicity, human antihuman antibody (HAHA) response, pharmacokinetics, organ dosimetry, targeting, and preliminary efficacy of yttrium-90–labeled anti–prostate-specific membrane antigen monoclonal antibody J591 (90Y-J591) in patients with androgen-independent prostate cancer (PC). Patients and Methods Patients with androgen-independent PC and evidence of disease progression received indium-111–J591 for pharmacokinetic and biodistribution determinations followed 1 week later by 90Y-J591 at five dose levels: 5, 10, 15, 17.5, and 20 mCi/m2. Patients were eligible for up to three re-treatments if platelet and neutrophil recovery was satisfactory. Results Twenty-nine patients with androgen-independent PC received 90Y-J591, four of whom were re-treated. Dose limiting toxicity (DLT) was seen at 20 mCi/m2, with two patients experiencing thrombocytopenia with non–life-threatening bleeding episodes requiring platelet transfusions. The 17.5-mCi/m2 dose level was determined to be the MTD. No re-treated patients experienced DLT. Nonhematologic toxicity was not dose limiting. Targeting of known sites of bone and soft tissue metastases was seen in the majority of patients. No HAHA response was seen. Antitumor activity was seen, with two patients experiencing 85% and 70% declines in prostate-specific antigen (PSA) levels lasting 8 and 8.6 months, respectively, before returning to baseline. Both patients had objective measurable disease responses. An additional six patients (21%) experienced PSA stabilization. Conclusion The recommended dose for 90Y-J591 is 17.5 mCi/m2. Acceptable toxicity, excellent targeting of known sites of PC metastases, and biologic activity in patients with androgen-independent PC warrant further investigation of 90Y-J591 in the treatment of patients with PC.

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