Chemotherapy with VAC (VBL/ACT-D/CTX) for Differentiated and VBL/BLEO/CACP plus VP-16/IPP/CACP for Less Differentiated non-Testicular Germ Cell Tumors in Children and Adolescents
Basic Trial Information
|No phase specified||Treatment||Completed||under 20||GER-GPO-MAKEI-86/89|
I. Improve the prognosis of children and adolescents with malignant non-testicular germ cell tumors using combination chemotherapy with VAC (vinblastine/actinomycin-D/cyclophosphamide) in patients with differentiated disease and vinblastine/bleomycin/cis-platinum plus VP-16213/ifosfamide/cis-platinum in patients with less differentiated disease.
See General Eligibility Criteria
See General Eligibility Criteria
General Eligibility Criteria:
Children and adolescents under the age of 20 years with histologically proven malignant non-testicular germ cell tumors.
Accrual is expected to be completed in 3 years.
Patients enter Regimen A or B on the basis of tumor site, origin, and stage: those with tumors with more differentiated histology enter Regimen A; those with less differentiated germ cell tumors enter Regimen B. Regimen A: 3-Drug Combination Chemotherapy. VAC: Vinblastine, VBL, NSC-49842; Actinomycin-D, ACT-D, NSC-3053; Cyclophosphamide, CTX, NSC-26271. Regimen B: Induction and Consolidation, 3-Drug Combination Chemotherapy followed by 3-Drug Combination Chemotherapy with Bladder Protection. VBL; Bleomycin, BLEO, NSC-125066; cis-Platinum, CACP, NSC-119875; followed by VP-16213, VP-16, NSC-141540; Ifosfamide, IPP, NSC-109724; CACP; plus Mesna.
Calaminus G, Bamberg M, Harms D, et al.: Treatment of AFP/beta-HCG positive intracranial germ cell tumors (GCTs). [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-527, 183, 1993.
Calaminus G, Bamberg M, Jürgens H, et al.: Impact of surgery, chemotherapy and irradiation on long term outcome of intracranial malignant non-germinomatous germ cell tumors: results of the German Cooperative Trial MAKEI 89. Klin Padiatr 216 (3): 141-9, 2004 May-Jun.[PUBMED Abstract]
Calaminus G, Schneider DT, Bökkerink JP, et al.: Prognostic value of tumor size, metastases, extension into bone, and increased tumor marker in children with malignant sacrococcygeal germ cell tumors: a prospective evaluation of 71 patients treated in the German cooperative protocols Maligne Keimzelltumoren (MAKEI) 83/86 and MAKEI 89. J Clin Oncol 21 (5): 781-6, 2003.[PUBMED Abstract]
Schneider DT, Wessalowski R, Calaminus G, et al.: Treatment of recurrent malignant sacrococcygeal germ cell tumors: analysis of 22 patients registered in the German protocols MAKEI 83/86, 89, and 96. J Clin Oncol 19 (7): 1951-60, 2001.[PUBMED Abstract]
Trial Contact Information
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