Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003114
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With AIDS-Related Hodgkins Disease
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Oral Combination Chemotherapy in the Treatment of AIDS-Associated Hodgkins Disease
Status:
COMPLETED
Status Verified Date:
2010-06
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy with lomustine etoposide cyclophosphamide and procarbazine in treating patients with stage IIB stage III or stage IV AIDS-related Hodgkins disease
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy with lomustine etoposide cyclophosphamide and procarbazine in treating patients with stage IIB stage III or stage IV AIDS-related Hodgkins disease
Detailed Description:
OBJECTIVES
Determine the objective response rate response duration and survival of patients receiving lomustineetoposidecyclophosphamideprocarbazine CECP for stage IIB-IV AIDS-related Hodgkins disease
Assess the feasibility and toxic effects of CECP in this patient population
OUTLINE Patients receive oral lomustine on day 1 oral etoposide on days 1-3 and oral cyclophosphamide and procarbazine on days 22-31 Filgrastim granulocyte colony-stimulating factor is given subcutaneously on days 5-21 and 33-42 The course is repeated every 6 weeks
Patients with a complete or partial response after 1 course of treatment receive two additional courses but lomustine is omitted in the second course Patients with partial response or stable disease receive radiation therapy andor continued chemotherapy Patients failing to respond after 1 course are removed from the study
Patients will be followed every 3 months until death
PROJECTED ACCRUAL A minimum of 16 evaluable patients will be accrued
Determine the objective response rate response duration and survival of patients receiving lomustineetoposidecyclophosphamideprocarbazine CECP for stage IIB-IV AIDS-related Hodgkins disease
Assess the feasibility and toxic effects of CECP in this patient population
OUTLINE Patients receive oral lomustine on day 1 oral etoposide on days 1-3 and oral cyclophosphamide and procarbazine on days 22-31 Filgrastim granulocyte colony-stimulating factor is given subcutaneously on days 5-21 and 33-42 The course is repeated every 6 weeks
Patients with a complete or partial response after 1 course of treatment receive two additional courses but lomustine is omitted in the second course Patients with partial response or stable disease receive radiation therapy andor continued chemotherapy Patients failing to respond after 1 course are removed from the study
Patients will be followed every 3 months until death
PROJECTED ACCRUAL A minimum of 16 evaluable patients will be accrued
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-G97-1351 | Other Identifier | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CWRU-2496 | OTHER | None | None |
| AMC-4A-90 | None | None | None |