High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Bone Marrow Transplantation for Relapsed and Refractory Germ Cell Cancer: A Phase II Pilot Study
- Investigate the response rate, duration of response, survival, time to marrow
reconstitution, and toxicity of two successive cycles of high dose carboplatin,
etoposide, and cyclophosphamide chemotherapy and ABMT in patients with relapsed and
refractory germ cell cancer or other chemotherapy-sensitive solid tumors.
- Further define the pretransplant characteristics of patients and their disease that
might influence the outcome of this therapy.
OUTLINE: Patients receive carboplatin and etoposide for 5 days and cyclophosphamide for 2
days prior to ABMT.
At day 60 following ABMT, if the patient has a complete response (CR) or partial response
(PR) and nonhematologic toxicity is no greater than grade 2, a second ABMT course is given
when hematologic parameters and other criteria are acceptable. If there is no CR or PR
and/or nonhematologic toxicity exceeds grade 2, a second ABMT is not given.
After ABMT patients are followed until disease progression or death.
PROJECTED ACCRUAL: Ten patients will be accrued for this pilot study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To investigate the response rate High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Transplantation
David D. Hurd, MD
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|