This is a phase 2 study of gemcitabine + high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue for Hodgkin's Disease
To assess the non-hematologic toxicity and determine the phase 2 dose of gemcitabine in combination with vinorelbine followed by carmustine, etoposide and cyclophosphamide and autologous hematopoietic stem cell transplantation \[aka peripheral blood stem cell (PBSC)\].
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
146
Stanford University School of Medicine
Stanford, California, United States
Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity
Reported as the number of Phase 1 participants by gemcitabine dose that experienced non-hematologic toxicity, ie, drug-related adverse events.
Time frame: 6 months
Pulmonary Toxicity (BCNU Pneumonitis)
Pulmonary toxicity as assessed by the number of participants that experience BCNU pneumonitis, ie, pneumonitis due to carmustine (BCNU).
Time frame: 2 years
Overall Survival (OS)
Reports the percentage of participants surviving 6 months after PBSC infusion (transplant).
Time frame: 2 years
Relapse Post-transplant
Reports the percentage of participants that experienced relapse post-transplant.
Time frame: 2 years
Survival Measures
Reports the survival measures: * Freedom from progression (FFP) * Event-free survival (EFS) * Overall survival (OS) EFS and OS were estimated by Kaplan-Meier method Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: 2 years
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