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A phase I dose escalation study of high-dose thiotepa, melphalan and carboplatin (TMCb) followed by autologous peripheral blood stem cell transplantation (PBSCT) in patients with solid tumors and hematologic malignancies.
Bone Marrow Transplant. 2000 Apr; 25(7):697-703.BM

Abstract

The purpose of this study was to determine the maximum tolerated dose of carboplatin administered with 500 mg/m2 thiotepa and 100 mg/m2 melphalan followed by autologous peripheral blood stem cell (PBSC) infusion in patients with refractory malignancies. Twenty-eight patients with refractory malignancies received high-dose thiotepa (500 mg/m2, melphalan (100 mg/m2) and escalating doses of carboplatin 900-1500 mg/m2) followed by infusion of cryopreserved autologous PBSCs. The maximum tolerated doses were determined to be 500 mg/m2 thiotepa, 100 mg/m2 melphalan and 1350 mg/m2 carboplatin. Two consecutive patients receiving 1500 mg/m2 carboplatin experienced grade 3 mucositis and colitis. Ten patients were enrolled at the maximum tolerated dose and none had grade 3-4 regimen-related toxicity and mortality. All patients at this level experienced grade 1-2 mucositis, 90% grade 1-2 gastrointestinal toxicity, 30% grade 1-2 cardiac and renal toxicity, and 10% experienced grade 1 hepatic toxicity. The median time to achieve a granulocyte count of 0.5x10(9)/l was 9 days (range 7-12 days) and platelet count of 20x10(9)/l was 10 days (range 7-15 days). Of eight patients with stage IV refractory breast cancer, even were evaluable for response, one patient on day 75 will be evaluated soon. Five of seven (71.5%) evaluable patients achieved a complete remission (CR) and two had no response. Of seven patients with non-Hodgkin's lymphoma (n = 4) or Hodgkin's disease (n = 3), five achieved a CR (71.5%). Thiotepa, melphalan and carboplatin can be administered in high doses with tolerable mucositis as the major side-effect. This combination has significant activity in patients with breast cancer, and phase II studies in patients with breast cancer and other chemotherapy-sensitive malignancies are warranted.

Authors+Show Affiliations

Ankara University Medical School, Ibni Sina Hospital, Department of Hematology/Oncology and Bone Marrow Transplant Unit, Ankara, Turkey.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase I
Journal Article
Multicenter Study

Language

eng

PubMed ID

10745253

Citation

Demirer, T, et al. "A Phase I Dose Escalation Study of High-dose Thiotepa, Melphalan and Carboplatin (TMCb) Followed By Autologous Peripheral Blood Stem Cell Transplantation (PBSCT) in Patients With Solid Tumors and Hematologic Malignancies." Bone Marrow Transplantation, vol. 25, no. 7, 2000, pp. 697-703.
Demirer T, Ilhan O, Mandel NM, et al. A phase I dose escalation study of high-dose thiotepa, melphalan and carboplatin (TMCb) followed by autologous peripheral blood stem cell transplantation (PBSCT) in patients with solid tumors and hematologic malignancies. Bone Marrow Transplant. 2000;25(7):697-703.
Demirer, T., Ilhan, O., Mandel, N. M., Arat, M., Günel, N., Celebi, H., Ustün, C., Akan, H., Demirer, S., Aydintuğ, S., Uysal, A., & Koç, H. (2000). A phase I dose escalation study of high-dose thiotepa, melphalan and carboplatin (TMCb) followed by autologous peripheral blood stem cell transplantation (PBSCT) in patients with solid tumors and hematologic malignancies. Bone Marrow Transplantation, 25(7), 697-703.
Demirer T, et al. A Phase I Dose Escalation Study of High-dose Thiotepa, Melphalan and Carboplatin (TMCb) Followed By Autologous Peripheral Blood Stem Cell Transplantation (PBSCT) in Patients With Solid Tumors and Hematologic Malignancies. Bone Marrow Transplant. 2000;25(7):697-703. PubMed PMID: 10745253.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A phase I dose escalation study of high-dose thiotepa, melphalan and carboplatin (TMCb) followed by autologous peripheral blood stem cell transplantation (PBSCT) in patients with solid tumors and hematologic malignancies. AU - Demirer,T, AU - Ilhan,O, AU - Mandel,N M, AU - Arat,M, AU - Günel,N, AU - Celebi,H, AU - Ustün,C, AU - Akan,H, AU - Demirer,S, AU - Aydintuğ,S, AU - Uysal,A, AU - Koç,H, PY - 2000/4/4/pubmed PY - 2000/5/20/medline PY - 2000/4/4/entrez SP - 697 EP - 703 JF - Bone marrow transplantation JO - Bone Marrow Transplant VL - 25 IS - 7 N2 - The purpose of this study was to determine the maximum tolerated dose of carboplatin administered with 500 mg/m2 thiotepa and 100 mg/m2 melphalan followed by autologous peripheral blood stem cell (PBSC) infusion in patients with refractory malignancies. Twenty-eight patients with refractory malignancies received high-dose thiotepa (500 mg/m2, melphalan (100 mg/m2) and escalating doses of carboplatin 900-1500 mg/m2) followed by infusion of cryopreserved autologous PBSCs. The maximum tolerated doses were determined to be 500 mg/m2 thiotepa, 100 mg/m2 melphalan and 1350 mg/m2 carboplatin. Two consecutive patients receiving 1500 mg/m2 carboplatin experienced grade 3 mucositis and colitis. Ten patients were enrolled at the maximum tolerated dose and none had grade 3-4 regimen-related toxicity and mortality. All patients at this level experienced grade 1-2 mucositis, 90% grade 1-2 gastrointestinal toxicity, 30% grade 1-2 cardiac and renal toxicity, and 10% experienced grade 1 hepatic toxicity. The median time to achieve a granulocyte count of 0.5x10(9)/l was 9 days (range 7-12 days) and platelet count of 20x10(9)/l was 10 days (range 7-15 days). Of eight patients with stage IV refractory breast cancer, even were evaluable for response, one patient on day 75 will be evaluated soon. Five of seven (71.5%) evaluable patients achieved a complete remission (CR) and two had no response. Of seven patients with non-Hodgkin's lymphoma (n = 4) or Hodgkin's disease (n = 3), five achieved a CR (71.5%). Thiotepa, melphalan and carboplatin can be administered in high doses with tolerable mucositis as the major side-effect. This combination has significant activity in patients with breast cancer, and phase II studies in patients with breast cancer and other chemotherapy-sensitive malignancies are warranted. SN - 0268-3369 UR - https://www.unboundmedicine.com/medline/citation/10745253/A_phase_I_dose_escalation_study_of_high_dose_thiotepa_melphalan_and_carboplatin__TMCb__followed_by_autologous_peripheral_blood_stem_cell_transplantation__PBSCT__in_patients_with_solid_tumors_and_hematologic_malignancies_ L2 - https://doi.org/10.1038/sj.bmt.1702239 DB - PRIME DP - Unbound Medicine ER -