Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Completed	under 20		GER-GPO-MAKEI-86/89

Objectives

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.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

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.

Expected Enrollment

Accrual is expected to be completed in 3 years.

Outline

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

Trial Lead Organizations

Universitaetsklinikum Duesseldorf

Ulrich Goebel, MD, Protocol chair(Contact information may not be current)		Ph: 49-211-311-7990