High-dose VP-16-213 monotherapy for refractory germinal malignancies: a phase II study.

1984 ◽  
Vol 2 (4) ◽  
pp. 271-274 ◽  
Author(s):  
S N Wolff ◽  
D H Johnson ◽  
J D Hainsworth ◽  
F A Greco
Keyword(s):  
Germ Cell ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Standard Dose ◽  
Autologous Bone Marrow Transplantation ◽  
Germ Cell Tumors ◽  
Autologous Bone Marrow ◽  
High Dose ◽  
Hematopoietic Reconstitution ◽  
Previous Phase

VP-16-213 at standard dose is one of the more active agents for the treatment of germ cell tumors. In previous phase I studies, VP-16-213 has been investigated in suprastandard dose when hematopoietic reconstitution was assured by autologous bone marrow transplantation (ABMT). This phase II study was performed to explore the possibility that an augmented dose of VP-16-213 may be more active than standard dose against germ cell tumors. Eleven patients with progressive refractory germ cell tumors were treated with high-dose VP-16-213: 2,400 mg/m2 with ABMT every three to four weeks followed by 1,200 mg/m2 without ABMT. Seven patients had received VP-16-213 at standard dose prior to high-dose VP-16-213. Toxicity to high-dose VP-16-213 included severe myelosuppression, nausea, vomiting, alopecia, mucositis, and hepatitis. Of 10 evaluable patients, two complete responses and four partial responses, all of short duration, were obtained. However, some patients unresponsive to standard-dose VP-16-213 exhibited responses to the augmented-dose VP-16-213. Therefore, although more myelosuppressive, VP-16-213 may have increased activity against germ cell tumors when administered at augmented dose. High-dose VP-16-213 may be considered in designing new approaches for initial management of patients with germ cell tumors not expected to be cured with standard chemotherapy.

High-dose busulfan and cyclophosphamide with autologous bone marrow transplantation support in advanced malignancies in children: a phase II study.

1986 ◽  
Vol 4 (12) ◽  
pp. 1804-1810 ◽  
Author(s):  
O Hartmann ◽  
E Benhamou ◽  
F Beaujean ◽  
J L Pico ◽  
C Kalifa ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Bone Marrow Transplantation ◽  
Phase Ii ◽  
Marrow Transplantation ◽  
Residual Disease ◽  
Phase Ii Study ◽  
Autologous Bone Marrow Transplantation ◽  
Autologous Bone Marrow ◽  
Terminal State ◽  
High Dose

Twenty children with advanced, nonleukemic malignancies entered a phase II study of high-dose busulfan-cyclophosphamide followed by bone marrow transplantation (BMT). All had disease refractory to conventional and/or high-dose chemotherapy (HDC). There were ten neuroblastoma patients, six non-Hodgkin's lymphoma, three Ewing's sarcoma, and one rhabdomyosarcoma. Eight had primarily resistant disease, ten were in second progressive relapse, and two in third progressive relapse. One patient was not evaluable for response. Among the 19 evaluable patients the responses observed were complete response (CR), seven; partial response (PR), three; objective effect, five; and failure, four. However, survival was poor: 15 patients died, two are alive with disease, and three are alive with no evidence of disease (NED) at 8+, 11+, 14+ months post-BMT. Toxicity was high but considered as acceptable, taking into account the terminal state of these patients. Seven treatment-related deaths were observed. This combination therapy proved to be highly effective, with a response rate of 50%, and its value for eradication of residual disease in less advanced patients should be investigated.

A Phase II Study of High-Dose Cisplatin, Vinblastine, Bleomycin, and Etoposide (PVeBV Regimen) in Malignant Nondysgerminomatous Germ-Cell Tumors of the Ovary

1994 ◽  
Vol 54 (1) ◽  
pp. 47-53 ◽  
Author(s):  
Stéphane Culine ◽  
Joseph Kattan ◽  
Catherine Lhomme ◽  
Pierre Duvillard ◽  
Guy Michel ◽  
...  
Keyword(s):  
Germ Cell ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Germ Cell Tumors ◽  
High Dose

Surgical salvage of chemorefractory germ cell tumors.

1993 ◽  
Vol 11 (2) ◽  
pp. 324-329 ◽  
Author(s):  
B R Murphy ◽  
E S Breeden ◽  
J P Donohue ◽  
J Messemer ◽  
W Walsh ◽  
...  
Keyword(s):  
Germ Cell ◽  
Salvage Surgery ◽  
Autologous Bone Marrow Transplantation ◽  
Elevated Serum ◽  
Germ Cell Tumors ◽  
Autologous Bone Marrow ◽  
Postoperative Treatment ◽  
High Dose ◽  
Repeat Surgery ◽  
Disease Free

PURPOSE Patients with disseminated germ cell tumors who relapse after salvage chemotherapy, or who progress during cisplatin-based therapy, have chemorefractory disease and a very poor prognosis. A subset of these patients will have chemorefractory but resectable disease. We have therefore evaluated the role of salvage surgery in this patient population. PATIENTS AND METHODS We performed a retrospective review of all patients with disseminated germ cell tumors who were felt to have chemorefractory disease and underwent salvage surgery from 1977 to 1990 at Indiana University. All patients had elevated serum markers or other signs of progressive carcinoma. A total of 48 patients underwent surgery (33 retroperitoneal lymph node dissections [RPLNDs], six thoracotomies, three thoracoabdominal resections, and multiple asynchronous procedures in six patients). RESULTS Thirty-eight of 48 patients (79%) were rendered grossly free of disease and 29 (60%) obtained a serologic remission. Ten patients (21%) remain continuously disease-free with no postoperative treatment with a median follow-up of 46 months (range, 31 to 89). Six additional patients who relapsed after salvage surgery are currently disease-free with further treatment (four with repeat surgery and two with high-dose chemotherapy and autologous bone marrow transplantation [ABMT]). CONCLUSION Selected patients with chemorefractory but resectable germ cell tumors have definite potential for cure with salvage surgery.

Maintenance chemotherapy with daily oral etoposide following salvage therapy in patients with germ cell tumors.

1995 ◽  
Vol 13 (5) ◽  
pp. 1167-1169 ◽  
Author(s):  
M A Cooper ◽  
L H Einhorn
Keyword(s):  
Germ Cell ◽  
Salvage Therapy ◽  
Patient Population ◽  
Treated Patient ◽  
Standard Dose ◽  
Autologous Bone Marrow Transplantation ◽  
Germ Cell Tumors ◽  
Autologous Bone Marrow ◽  
Oral Etoposide ◽  
Grade Iii

PURPOSE To evaluate the role of maintenance daily oral etoposide (VP-16) chemotherapy for germ cell patients who had a response to salvage therapy. PATIENTS AND METHODS Thirty-seven patients were entered onto this trial, and 34 were fully assessable. This was as heavily pretreated patient population, with a median of two prior salvage regimens. The salvage treatment that immediately preceded oral VP-16 consisted of autologous bone marrow transplantation in 14 patients (41%), surgery in 10 (29%), and standard-dose salvage chemotherapy in 10 (29%). Daily oral VP-16 was administered at a dose of 50 mg/m2 for 21 consecutive days every 4 weeks for three cycles. RESULTS The major toxicity with daily oral VP-16 was leukopenia. Three patients had grade III and two grade IV leukopenia. Two of these patients had granulocytopenic fever. Other grade III toxicities included thrombocytopenia (n = 1) and mucositis (n = 2). Twenty-three patients started daily oral VP-16 while in complete remission (CR) following salvage therapy. Seventeen (74%) remain continuously disease-free, with a median follow-up time of 36 months (range, 26 to 49) from initiation of daily oral VP-16. Eleven patients started daily oral VP-16 while in partial remission (PR) following salvage therapy. Three of these 11 patients converted to CR, but all three subsequently relapsed. CONCLUSION Maintenance oral VP-16 was well tolerated in this heavily treated patient population. Results in this poor-risk population were encouraging.

scholarly journals A multi-center prospective phase II study of high-dose chemotherapy in germ-cell cancer patients relapsing from complete remission

1999 ◽  
Vol 10 (12) ◽  
pp. 1467-1474 ◽  
Author(s):  
S. Rodenhuis ◽  
R. de Wit ◽  
P.H.M. de Mulder ◽  
H.J. Keizer ◽  
D.T. Sleijfer ◽  
...  
Keyword(s):  
Complete Remission ◽  
Germ Cell ◽  
Cancer Patients ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Cell Cancer ◽  
High Dose Chemotherapy ◽  
Germ Cell Cancer ◽  
High Dose ◽  
Prospective Phase

scholarly journals Prolonged impairment of hematopoiesis after high-dose therapy followed by autologous bone marrow transplantation

Blood ◽  
1995 ◽  
Vol 85 (11) ◽  
pp. 3320-3327 ◽  
Author(s):  
J Domenech ◽  
C Linassier ◽  
E Gihana ◽  
A Dayan ◽  
D Truglio ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Bone Marrow Transplantation ◽  
Marrow Transplantation ◽  
Autologous Bone Marrow Transplantation ◽  
Autologous Bone Marrow ◽  
High Dose ◽  
High Dose Therapy ◽  
Colony Forming Unit ◽  
Hematopoietic Reconstitution

Hematopoietic reconstitution has been studied in 180 patients after autologous bone marrow transplantation based on peripheral blood cell (PBC) recovery time and marrow progenitor counts sequentially tested for up to 4 years. Several factors that could influence hematopoietic reconstitution have been analyzed including sex, age, diagnosis, disease status, conditioning regimen, graft progenitor content, graft in vitro purging, and postgrafting administration of growth factors. Before transplantation, marrow progenitor values were normal only for colony-forming unit granulocyte macrophage (CFU-GM) in contrast to colony-forming unit-erythroid (CFU-E), burst-forming unit-erythroid (BFU-E), and colony-forming unit-megakaryocyte (CFU-Meg). After transplantation, as described with allogenic grafts, these values remained low for several years, although PBC counts were nearly normalized within a few weeks. Pregraft values were reached after 2 years for CFU-GM and BFU-E, and after 4 years for CFU-E, while CFU-Meg failed to reach pregraft values after this time. Normal levels were reached after 4 years only by CFU-GM. On univariate and multivariate analysis, the following factors appeared to delay both PBC and marrow progenitor reconstitution: underlying disease (particularly acute myeloid leukemias), graft characteristics such as low stem cell content and in vitro purging, conditioning regimens with total body irradiation or busulfan, and lack of postgraft administration of growth factors. In conclusion, high-dose therapy followed by bone marrow transplantation induces a deep and prolonged impairment of hematopoiesis irrespective of any alloimmune reaction or postgraft immunosuppressive therapy.(ABSTRACT TRUNCATED AT 250 WORDS)

Paclitaxel, bleomycin, etoposid, and cisplatin (T-BEP) as initial treatment in poor prognostic germ cell tumors (GCT). A phase II study

2005 ◽  
Vol 23 (16_suppl) ◽  
pp. 4679-4679
Author(s):  
J. Mardiak ◽  
T. Salek ◽  
Z. Sycova-Mila ◽  
J. Obertova ◽  
M. Reckova ◽  
...  
Keyword(s):  
Germ Cell ◽  
Phase Ii ◽  
Initial Treatment ◽  
Phase Ii Study ◽  
Germ Cell Tumors
Sign in / Sign up

Export Citation Format

Share Document