Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors

Phase 2 Completed 27 enrolled Children's Oncology Group National Cancer Institute (NCI) · collab

Treatment

Summary

RATIONALE: Chemotherapy drugs use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase I trial to study the effectiveness of high-dose cisplatin, etoposide, and bleomycin plus amifostine in treating children who have malignant germ cell tumors.

Timeline

Start: 2000-04
Primary completion: 2004-10
Completion: 2007-09

Outcome

Missed primary endpoint

paper CONCLUSIONS: Amifostine did not protect against HDPEB-associated ototoxicity. PMID 15999362 ↗

Publications

Results Marina N, Chang KW, Malogolowkin M, London WB, Frazier AL, Womer RB, Rescorla F, Billmire DF, Davis MM, Perlman EJ, Giller R, Lauer SJ, Olson TA; Children's Oncology Group. Amifostine does not protect against the ototoxicity of high-dose cisplatin combined with etoposide and bleomycin in pediatric germ-cell tumors: a Children's Oncology Group study. Cancer. 2005 Aug 15;104(4):841-7. doi: 10.1002/cncr.21218.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bleomycin	Unknown	15 unknown	Intravenous
Subject	Cisplatin	Other / unclassified	40 mg/m2	Intravenous
Subject	Etoposide	Small molecule	100 mg/m2	Intravenous
Subject	amifostine	Unknown	825 mg/m2	Intravenous