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Clinical Trials (PDQ®)

  • Last Modified: 12/13/2007

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Clinical Trials (PDQ®)

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedTreatmentCompletedunder 20GER-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.

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 Contact Information

Trial Lead Organizations

Universitaetsklinikum Duesseldorf

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

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.

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