Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002461
Status:
COMPLETED
Last Update Posted:
2018-08-17
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Refractory Hodgkins Disease or Non-Hodgkins Lymphoma
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Phase II Study of Intensive Carmustine and Etoposide With Cisplatin or Cyclophosphamide Followed By Rescue With Autologous Bone Marrow Treated In Vitro With Etoposide andor Peripheral Blood Stem Cells Mobilized With Filgrastim G-CSF or Sargramostim GM-CSF With or Without Radiotherapy in Patients With Resistant Hodgkins Disease or Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2018-08
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells Bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy to kill more cancer cells
PURPOSE This phase II trial is studying giving high-dose chemotherapy followed by bone marrow or peripheral stem cell transplantation to see how well it works in treating patients with refractory Hodgkins disease or non-Hodgkins lymphoma
PURPOSE This phase II trial is studying giving high-dose chemotherapy followed by bone marrow or peripheral stem cell transplantation to see how well it works in treating patients with refractory Hodgkins disease or non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the antitumor activity of intensive carmustine and etoposide with cisplatin or cyclophosphamide followed by rescue with autologous bone marrow ABM treated in vitro with etoposide andor peripheral blood stem cells mobilized with filgrastim G-CSF or sargramostim GM-CSF with or without radiotherapy in patients with refractory Hodgkins disease or non-Hodgkins lymphoma II Determine the time to recovery of peripheral blood counts in patients treated with this regimen III Correlate the rate of peripheral blood cell recovery in these patients with in vitro growth of ABM treated with etoposide
OUTLINE This is a multicenter study Autologous bone marrow ABM is harvested and two-thirds of the ABM is treated in vitro with etoposide VP-16 ABM may have been stored earlier in the course of the disease for patients who are at high risk of relapse or who were previously treated with agents causing bone marrow or stem cell damage eg nitrosoureas pelvic irradiation Patients with prior bone marrow involvement and subsequent bone marrow remission must have received 1 or 2 additional courses of the same chemotherapy before undergoing harvest of ABM Patients for whom PBSC rescue alone is planned also undergo ABM harvest in case back-up ABM rescue is needed Patients then receive sargramostim GM-CSF or filgrastim G-CSF subcutaneously beginning 5 days before harvest of peripheral blood stem cells PBSC and continuing until completion of harvest Patients without extensive prior radiotherapy undergo radiotherapy to areas of measurable active disease plus a 2 cm margin on days -21 to -17 and -14 to -8 Patients without a contraindication to cisplatin eg hearing impairment peripheral neuropathy receive cisplatin IV over 3 hours on days -7 to -3 and carmustine IV over 2 hours and VP-16 IV over 4 hours on days -6 to -4 Patients with a contraindication to cisplatin receive cyclophosphamide IV every 12 hours VP-16 IV over 1 hour every 12 hours and carmustine IV over 1 hour on days -7 to -4 ABM andor PBSC are reinfused on day 0 The first 6 ABM rescue patients receive untreated ABM and subsequent patients receive ABM treated in vitro with VP-16 Patients with bone marrow biopsy showing no evidence of regeneration marrow cellularity less than 1 at day 21 after PBSC rescue undergo back-up ABM rescue Patients without engraftment granulocyte count less than 500mm3 and untransfused platelets no greater than 20000mm3 by day 28 after rescue with ABM treated in vitro with VP-16 undergo rescue with untreated ABM
PROJECTED ACCRUAL A total of 21-46 patients will be accrued for this study
OUTLINE This is a multicenter study Autologous bone marrow ABM is harvested and two-thirds of the ABM is treated in vitro with etoposide VP-16 ABM may have been stored earlier in the course of the disease for patients who are at high risk of relapse or who were previously treated with agents causing bone marrow or stem cell damage eg nitrosoureas pelvic irradiation Patients with prior bone marrow involvement and subsequent bone marrow remission must have received 1 or 2 additional courses of the same chemotherapy before undergoing harvest of ABM Patients for whom PBSC rescue alone is planned also undergo ABM harvest in case back-up ABM rescue is needed Patients then receive sargramostim GM-CSF or filgrastim G-CSF subcutaneously beginning 5 days before harvest of peripheral blood stem cells PBSC and continuing until completion of harvest Patients without extensive prior radiotherapy undergo radiotherapy to areas of measurable active disease plus a 2 cm margin on days -21 to -17 and -14 to -8 Patients without a contraindication to cisplatin eg hearing impairment peripheral neuropathy receive cisplatin IV over 3 hours on days -7 to -3 and carmustine IV over 2 hours and VP-16 IV over 4 hours on days -6 to -4 Patients with a contraindication to cisplatin receive cyclophosphamide IV every 12 hours VP-16 IV over 1 hour every 12 hours and carmustine IV over 1 hour on days -7 to -4 ABM andor PBSC are reinfused on day 0 The first 6 ABM rescue patients receive untreated ABM and subsequent patients receive ABM treated in vitro with VP-16 Patients with bone marrow biopsy showing no evidence of regeneration marrow cellularity less than 1 at day 21 after PBSC rescue undergo back-up ABM rescue Patients without engraftment granulocyte count less than 500mm3 and untransfused platelets no greater than 20000mm3 by day 28 after rescue with ABM treated in vitro with VP-16 undergo rescue with untreated ABM
PROJECTED ACCRUAL A total of 21-46 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 |
|---|---|---|---|
| P30CA013330 | NIH | None | None |
| AECM-8802027 | None | None | None |
| NCI-V89-0089 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA013330 |