Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002905
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkins Lymphoma
Sponsor:
Centro di Riferimento Oncologico - Aviano
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PROSPECTIVE NON-RANDOMIZED STUDY WITH CHEMOTHERAPY FOR RELAPSED OR REFRACTORY HIV-RELATED NON-HODGKINS LYMPHOMA VMP REGIMEN FOR RELAPSED PATIENTS CDE REGIMEN FOR REFRACTORY PATIENTS
Status:
UNKNOWN
Status Verified Date:
2011-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients with HIV-related non-Hodgkins lymphoma that has relapsed or has not responded to chemotherapy
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients with HIV-related non-Hodgkins lymphoma that has relapsed or has not responded to chemotherapy
Detailed Description:
OBJECTIVES I Evaluate the response rate and duration of response to etoposide mitoxantrone and prednimustine in patients with relapsed HIV-associated non-Hodgkins lymphoma NHL II Evaluate the response rate and duration of response to cyclophosphamide doxorubicin and etoposide in patients with refractory HIV-associated NHL III Assess the toxic effects of these regimens in these patients
OUTLINE Patients with relapsed non-Hodgkins lymphoma NHL receive oral etoposide and prednimustine on days 1-5 and intravenous mitoxantrone on day 1 every 3 weeks Patients with refractory NHL receive cyclophosphamide doxorubicin and etoposide as a continuous infusion over 4 days every 4 weeks All patients receive concomitant antiretroviral therapy with zidovudine or didanosine G-CSF is given for hematologic support as indicated All patients are evaluated for response after 2 courses of chemotherapy Patients with a complete response CR receive 2 additional courses Patients with a stable or partial response receive 2 additional courses and are re-evaluated those with a CR receive 2 more courses while those with a stable or partial response are treated off study at the physicians discretion Patients with progressive disease are removed from study
PROJECTED ACCRUAL 15-20 patients will be treated on each regimen
OUTLINE Patients with relapsed non-Hodgkins lymphoma NHL receive oral etoposide and prednimustine on days 1-5 and intravenous mitoxantrone on day 1 every 3 weeks Patients with refractory NHL receive cyclophosphamide doxorubicin and etoposide as a continuous infusion over 4 days every 4 weeks All patients receive concomitant antiretroviral therapy with zidovudine or didanosine G-CSF is given for hematologic support as indicated All patients are evaluated for response after 2 courses of chemotherapy Patients with a complete response CR receive 2 additional courses Patients with a stable or partial response receive 2 additional courses and are re-evaluated those with a CR receive 2 more courses while those with a stable or partial response are treated off study at the physicians discretion Patients with progressive disease are removed from study
PROJECTED ACCRUAL 15-20 patients will be treated on each regimen
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 |
|---|---|---|---|
| EU-96059 | None | None | None |
| ITA-GICAT-C-941202-3 | None | None | None |