Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003269
Status:
COMPLETED
Last Update Posted:
2011-01-10
First Post:
1999-11-01
Brief Title:
Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors
Sponsor:
Scripps Health
Organization:
Scripps Health
Study Overview
Official Title:
A Phase II Open-Label Trial Evaluating the Efficacy of Amifostine in Patients With Cancers Receiving Outpatient Dose-intensive Cyclophosphamide Etoposide and Cisplatin DICEP Chemotherapy
Status:
COMPLETED
Status Verified Date:
2011-01
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 tumor cells from dividing so they stop growing or die Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy
PURPOSE Randomized phase II trial to study the effectiveness of amifostine followed by high-dose chemotherapy in treating patients with hematologic cancer or solid tumors
PURPOSE Randomized phase II trial to study the effectiveness of amifostine followed by high-dose chemotherapy in treating patients with hematologic cancer or solid tumors
Detailed Description:
OBJECTIVES I Evaluate the efficacy of amifostine in enhancing hematopoietic recovery following cyclophosphamide etoposide and cisplatin therapy in patients with hematologic malignancies and adult solid tumors
OUTLINE This is an open label study Patients receive intravenous amifostine over 15 minutes daily 30 minutes prior to high dose chemotherapy on days 0-2 Cyclophosphamide is administered over 3 hours on days 0 and 1 intravenous etoposide over 4 hours on days 0 1 and 2 and cisplatin over 4 hours on days 0 1 and 2 All patients receive sargramostim GM-CSF beginning on day 4 Patients receive a maximum of 2 courses of treatment with 35-42 days between chemotherapy courses Patients are followed for 1-5 months after treatment
PROJECTED ACCRUAL Approximately 20 patients will be accrued for this study within 12 months
OUTLINE This is an open label study Patients receive intravenous amifostine over 15 minutes daily 30 minutes prior to high dose chemotherapy on days 0-2 Cyclophosphamide is administered over 3 hours on days 0 and 1 intravenous etoposide over 4 hours on days 0 1 and 2 and cisplatin over 4 hours on days 0 1 and 2 All patients receive sargramostim GM-CSF beginning on day 4 Patients receive a maximum of 2 courses of treatment with 35-42 days between chemotherapy courses Patients are followed for 1-5 months after treatment
PROJECTED ACCRUAL Approximately 20 patients will be accrued for this study within 12 months
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 |
|---|---|---|---|
| NCI-V98-1396 | OTHER | NCI | None |
| SCRF-98014 | OTHER | None | None |
| ALZA-97-49-ii | OTHER | None | None |