Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors
- Determine overall survival (OS) of patients with germ cell tumors treated with tandem
autologous stem cell transplantation with non-cross-resistant conditioning regimens.
- Determine disease-free survival (DFS) of patients treated with this regimen.
- Determine the toxicity of tandem transplants
- Determine the time to engraftment of neutrophils and platelets in patients treated for
- Determine the number of patients unable to adequately mobilize sufficient peripheral
blood stem cells (PBSC) for tandem transplantation.
- Identify prognostic factors of patients unlikely to mobilize sufficient PBSC for tandem
- Compare OS and DFS of patients undergoing single vs tandem transplantation.
- Peripheral blood stem cell (PBSC) mobilization with filgrastim (G-CSF): Patients
receive G-CSF subcutaneously (SC) beginning on day 1 and continuing until stem cell
collection is complete. Patients undergo stem cell collection beginning on day 5 of
G-CSF administration and continuing for at least 3 collections until the collection
goal is met.
- Second PBSC mobilization with chemotherapy: Patients not meeting the collection goal
receive cyclophosphamide IV over 2 hours on day 1 and G-CSF SC beginning on day 4 and
continuing until stem cell collection is complete. Patients meeting the collection goal
after PBSC mobilization via G-CSF alone or in combination with chemotherapy will
undergo tandem autologous transplantation. If collection goal is not met but the
patient has collected > or = 2 x 10^6 CD34 cells/kg, a single autologous transplant
will be performed.
- Single stem cell transplantation (SCT): Patients receive paclitaxel IV over 3 hours on
day -7 and ifosfamide IV on days -6 to -4. Patients undergo reinfusion of stem cells on
day 0. Patients also receive G-CSF SC or IV beginning on day 1 and continuing until
blood counts recover.
- Tandem SCT: Patients receive treatment as in single SCT. Beginning 30-90 days later,
patients receive carboplatin IV over 60 minutes and thiotepa IV over 30 minutes on days
-6 to -4 and etoposide IV over 60 minutes on days -6 to -3. Patients undergo reinfusion
of stem cells on day 0. Patients also receive G-CSF SC or IV beginning on day 5 and
continuing until blood counts recover.
After completion of study treatment, patients are followed at 6, 9, and 12 months and then
every 6 months for up to 2 years.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival (OS)
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.
Brian McClune, DO
Masonic Cancer Center, University of Minnesota
United States: Institutional Review Board
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