Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003261
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Brief Title:
Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma
Sponsor:
Centro di Riferimento Oncologico - Aviano
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Treatment of HIV-Related Primary Central Nervous System Lymphoma HIV-PCNSL A Phase II Trial With Neoadjuvant Chemotherapy High-Dose Methotrexate MTX Plus High-Dose Zidovudine and Radiotherapy
Status:
UNKNOWN
Status Verified Date:
2001-10
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 tumor cells from dividing so they stop growing or die Combining radiation therapy with chemotherapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving methotrexate and zidovudine together with radiation therapy works in treating patients with HIV-related primary central nervous system lymphoma
PURPOSE This phase II trial is studying how well giving methotrexate and zidovudine together with radiation therapy works in treating patients with HIV-related primary central nervous system lymphoma
Detailed Description:
OBJECTIVES
Determine the efficacy of neoadjuvant chemotherapy and radiation therapy in the treatment of HIV-related primary CNS lymphoma patients
Evaluate the toxicity and overall survival of these patients
OUTLINE Patients receive chemotherapy consisting of high-dose methotrexate IV administered on day 1 and high-dose zidovudine IV administered on days 1-3 every 2 weeks Patients receive 3 courses of therapy Following chemotherapy patients receive radiation therapy to the lesion site daily
Patients are followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL This study will accrue 14 patients
Determine the efficacy of neoadjuvant chemotherapy and radiation therapy in the treatment of HIV-related primary CNS lymphoma patients
Evaluate the toxicity and overall survival of these patients
OUTLINE Patients receive chemotherapy consisting of high-dose methotrexate IV administered on day 1 and high-dose zidovudine IV administered on days 1-3 every 2 weeks Patients receive 3 courses of therapy Following chemotherapy patients receive radiation therapy to the lesion site daily
Patients are followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL This study will accrue 14 patients
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-97018 | None | None | None |
| ITA-GICAT-POS1 | None | None | None |