BSD-2000 Published Clinical Studies

Phase I, II & III Clinical Studies that used the BSD-2000

Authors: Westermann AM, Jones EL, Schem BC, van der Steen-Banasik EM, Koper P, Mella O, Uitterhoeve AL, de Wit R, van der Velden J, Burger C, van der Wilt CL, Dahl O, Prosnitz LR, van der Zee J.
Publication: Cancer. 2005 Aug 15;104(4):763-70.

BACKGROUND:
Patients with advanced cervical carcinoma are treated routinely with radiotherapy and cisplatin-containing chemotherapy. It has been shown that hyperthermia can improve the results of both radiotherapy and cisplatin. In the current study, the feasibility and efficacy of the combination of all three modalities was studied in previously untreated patients with cervical carcinoma.

Authors: Wessalowski R, Kruck H, Pape H, Kahn T, Willers R, Göbel U.
Publication: Cancer. 1998 Feb 15;82(4):793-800.

PURPOSE:
Extracranial nontesticular germ cell tumors (GCTs) are rare malignancies in children and adolescents. Cisplatin-containing regimens and complete tumor resection are important determinants for a favorable outcome; however, patients with recurrent tumors that cannot be eradicated by surgical procedures and chemotherapy have a poor prognosis. Noninvasive electromagnetic technologies for superficial and regional deep hyperthermia (RHT) are under investigation to enhance local tumor control in various malignancies. The objectives of this Phase I/II study were to examine 1) whether RHT can be used in combination with platinum-based chemotherapy with acceptable toxicity in children and adolescents and 2) whether this combined regimen can induce objective tumor response in patients with malignant nontesticular GCT that persisted or recurred locoregionally after validated, intensive, cisplatin-based chemotherapy +/- surgery as unsuccessful first-line treatment.

Authors: Wessalowski R, Blohm M, Calaminus G, Engert J, Harms D, Krause I, Kruck H, Grüttner HP, Pape H, Göbel U.
Publication: Klin Padiatr. 1997 Jul-Aug;209(4):250-6.

PURPOSE:
In this study treatment results in children and adolescents (n = 32) suffering from loco-regional abdominal relapses of germ cell tumors (GCT) (7 embryonal carcinoma, 17 Yolk sac tumors, 8 immature teratomas) aged from 1;0 to 23;3 years (mean = 10;11 years) were evaluated.

Authors:  Wendtner C, Abdel-Rahman S, Baumert J, Falk MH, Krych M, Santl M, Hiddemann W, Issels RD
Publication: Eur J Cancer. 2001 Sep;37(13):1609-16.

PURPOSE:
The efficacy of thermochemotherapy in adult patients with primary, recurrent or inadequately resected non-metastatic high-risk soft-tissue sarcomas (STS) was assessed.

Authors: Tilly W, Gellermann J, Graf R, Hildebrandt B, Weissbach L, Budach V, Felix R, Wust P.
Publication: Strahlenther Onkol. 2005 Jan;181(1):35-41.

PURPOSE:
Since long-term results of the standard treatment of locally advanced or recurrent prostatic carcinoma are unsatisfactory, the role for additional regional hyperthermia was evaluated in a phase I/II study.

Authors: Tilly W, Wust P, Rau B, Harder C, Gellermann J, Schlag P, Budach V, Felix R.
Publication: Int J Hyperthermia. 2001 Mar-Apr;17(2):172-88.

PURPOSE:
The system BSD 2000 has been in clinical use for regional hyperthermia for more than 10 years. Several technical details of this hyperthermia system, as well as the results of clinical studies employing this system have been investigated. The intention of this paper is to investigate the correlation between technical efficiency or feasibility of hyperthermia with the BSD 2000, in terms of power densities and temperatures depending upon parameters such as tumour histology, tumour location, patient age, patient sex, and patient cross section.

Authors: Sreenivasa G, Hildebrandt B, Kümmel S, Jungnickel K, Cho CH, Tilly W, Böhmer D, Budach V, Felix R, Wust P.
Publication: Int J Radiat Oncol Biol Phys. 2006 Nov 15;66(4):1159-67. Epub 2006 Sep 18.

PURPOSE:
To evaluate preoperative radiochemotherapy combined with regional pelvic hyperthermia in patients with nonresectable cervical cancer >/= International Federation of Gynecology and Obstetrics (FIGO) IIB "bulky" in a Phase II study.