Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007813
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2001-01-06
Brief Title:
Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
TREATMENT OF CHILDREN AND YOUNG ADULTS WITH RECURRENTREFRACTORY SOLID TUMORS WITH HIGH DOSE ETOPOSIDE AND CARBOPLATIN PLUS ESCALATING DOSE CYCLOPHOSPHAMIDE FOLLOWED BY HEMATOPOIETIC RESCUE USING AUTOLOGOUS CD34 SELECTED BLOOD STEM CELLS A PILOT STUDY
Status:
COMPLETED
Status Verified Date:
2020-02
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 Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of cyclophosphamide when given together with combination chemotherapy and a peripheral stem cell transplant in treating patients with malignant solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of cyclophosphamide when given together with combination chemotherapy and a peripheral stem cell transplant in treating patients with malignant solid tumors
Detailed Description:
OBJECTIVES
Determine whether autologous transplantation of mobilized CD34 peripheral blood stem cells PBSC can provide complete hematologic reconstitution after myeloablative chemotherapy comprising etoposide VP-16 and carboplatin CBDCA in patients with metastatic or recurrent rhabdomyosarcoma neuroblastoma Ewings sarcomaprimitive neuroectodermal tumor germ cell tumors childhood brain tumors or hepatoblastoma
Determine the frequency and yield of CD34 PBSC and granulocyte-macrophage colony-forming units GM-CFU that are mobilized harvested and purified after a single priming course of high-dose cyclophosphamide CTX followed by filgrastim G-CSF
Correlate the number of CD34 cells and GM-CFU in the autologous PBSC graft with time to engraftment of white blood cells neutrophils and platelets in these patients
Determine the optimal day of PBSC harvest after a single priming course of high-dose CTX and G-CSF in these patients
Determine whether CD34 PBSC rescue and daily post-transplantation G-CSF decrease the time to hematopoietic recovery after high-dose VP-16 and CBDCA compared to historical results achieved in similar patients rescued with bone marrow
Compare the tumor cell content of marrow mobilized blood and purified CD34 PBSC graft preparations
Determine the optimal timing of PBSC mobilization and harvest in relation to extent of prior chemotherapy in these patients
Determine the feasibility of a single leukapheresis for PBSC harvest in children
Determine the toxic effects of this regimen in these patients
Determine the antitumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study of cyclophosphamide
Mobilizationharvest Patients receive cyclophosphamide IV over 90 minutes on day 0 and filgrastim G-CSF subcutaneously or IV over 30 minutes on days 2-15 or until blood counts recover Peripheral blood stem cells PBSC are harvested and selected for CD34 cells on day 15 Bone marrow is also harvested in case insufficient PBSC are harvested
Preparative regimentransplantation Patients receive carboplatin IV over 1 hour and etoposide IV continuously on days -6 to -4 Cyclophosphamide is administered IV over 1 hour on days -3 and -2 or IV continuously on days -3 and -2 -4 to -2 -5 to -2 or -6 to -2 PBSC or bone marrow is reinfused on day 0
Cohorts of 3-10 patients receive escalating doses of cyclophosphamide until the maximum tolerated dose MTD is determined The MTD is defined as the highest dose at which 20 of patients experience dose-limiting toxicity
At least 6 additional patients receive cyclophosphamide at the MTD
PROJECTED ACCRUAL A minimum of 36 patients will be accrued for this study
Determine whether autologous transplantation of mobilized CD34 peripheral blood stem cells PBSC can provide complete hematologic reconstitution after myeloablative chemotherapy comprising etoposide VP-16 and carboplatin CBDCA in patients with metastatic or recurrent rhabdomyosarcoma neuroblastoma Ewings sarcomaprimitive neuroectodermal tumor germ cell tumors childhood brain tumors or hepatoblastoma
Determine the frequency and yield of CD34 PBSC and granulocyte-macrophage colony-forming units GM-CFU that are mobilized harvested and purified after a single priming course of high-dose cyclophosphamide CTX followed by filgrastim G-CSF
Correlate the number of CD34 cells and GM-CFU in the autologous PBSC graft with time to engraftment of white blood cells neutrophils and platelets in these patients
Determine the optimal day of PBSC harvest after a single priming course of high-dose CTX and G-CSF in these patients
Determine whether CD34 PBSC rescue and daily post-transplantation G-CSF decrease the time to hematopoietic recovery after high-dose VP-16 and CBDCA compared to historical results achieved in similar patients rescued with bone marrow
Compare the tumor cell content of marrow mobilized blood and purified CD34 PBSC graft preparations
Determine the optimal timing of PBSC mobilization and harvest in relation to extent of prior chemotherapy in these patients
Determine the feasibility of a single leukapheresis for PBSC harvest in children
Determine the toxic effects of this regimen in these patients
Determine the antitumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study of cyclophosphamide
Mobilizationharvest Patients receive cyclophosphamide IV over 90 minutes on day 0 and filgrastim G-CSF subcutaneously or IV over 30 minutes on days 2-15 or until blood counts recover Peripheral blood stem cells PBSC are harvested and selected for CD34 cells on day 15 Bone marrow is also harvested in case insufficient PBSC are harvested
Preparative regimentransplantation Patients receive carboplatin IV over 1 hour and etoposide IV continuously on days -6 to -4 Cyclophosphamide is administered IV over 1 hour on days -3 and -2 or IV continuously on days -3 and -2 -4 to -2 -5 to -2 or -6 to -2 PBSC or bone marrow is reinfused on day 0
Cohorts of 3-10 patients receive escalating doses of cyclophosphamide until the maximum tolerated dose MTD is determined The MTD is defined as the highest dose at which 20 of patients experience dose-limiting toxicity
At least 6 additional patients receive cyclophosphamide at the MTD
PROJECTED ACCRUAL A minimum of 36 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 94-12-23-02 | OTHER | JHM IRB | None |
| CDR0000064263 | REGISTRY | None | None |
| NCI-V95-0688 | REGISTRY | None | None |