|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.Published Results
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]Related Publications
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 Lead Organizations
|Ulrich Goebel, MD, Protocol chair (Contact information may not be current)|
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.