Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 7:51 AM
Study NCT ID:
NCT00432094
Status:
COMPLETED
Last Update Posted:
2022-05-17
First Post:
2007-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors
Sponsor:
Masonic Cancer Center, University of Minnesota
Organization:
Study Overview
Official Title:
Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Germ cell tumors (GCT) are highly sensitive to chemotherapy such that even with metastatic disease at diagnosis, many patients can be cured. Patients who fall into the poor risk category or others who relapse can be successfully salvaged with high dose chemotherapy and autologous stem cell transplant (AuSCT). As in other diseases such as myeloma, sequential high dose chemotherapy and AuSCT may improve overall and disease free survival.
PURPOSE: Because prior investigations in GCT suggest that a subset of high risk or relapsed patients may be cured with sequential cycles of high dose chemotherapy and AuSCT, we propose investigating how well non-cross resistant conditioning regimens work in treating patients with relapsed or high risk GCT.
PURPOSE: Because prior investigations in GCT suggest that a subset of high risk or relapsed patients may be cured with sequential cycles of high dose chemotherapy and AuSCT, we propose investigating how well non-cross resistant conditioning regimens work in treating patients with relapsed or high risk GCT.
Detailed Description:
OBJECTIVES:
Primary
* Determine overall survival (OS) of patients with germ cell tumors treated with tandem autologous stem cell transplantation with non-cross-resistant conditioning regimens.
Secondary
* 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 each transplant
* 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 transplantation.
* Compare OS and DFS of patients undergoing single vs tandem transplantation.
OUTLINE:
* 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.
Primary
* Determine overall survival (OS) of patients with germ cell tumors treated with tandem autologous stem cell transplantation with non-cross-resistant conditioning regimens.
Secondary
* 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 each transplant
* 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 transplantation.
* Compare OS and DFS of patients undergoing single vs tandem transplantation.
OUTLINE:
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: