Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000723
Status:
TERMINATED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
The Use of Chemotherapy Plus Radiotherapy Plus Azidothymidine in Patients With AIDS-Related Lymph Node Cancer
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Chemotherapy Radiotherapy and Azidothymidine for AIDS-Related Primary CNS Lymphoma
Status:
TERMINATED
Status Verified Date:
2021-10
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:
To determine the safety and toxicity of high-dose systemic methotrexate MTX and dexamethasone DEX combined with zidovudine AZT and brain irradiation in patients with AIDS-related primary central nervous system CNS lymphoma and to determine response rates and survival of treated patients Also to determine if the treatment inhibits HIV replication in patients who are HIV culture andor antigen positive and to assess the incidence of opportunistic infection in these patients Results of radiation given to patients with AIDS-related high-grade CNS lymphoma have been disappointing with short survival times due to infection complications However complete response has been documented after radiation in some patients High-dose MTX will be used to improve the possibility of a greater antineoplastic response than that obtained by radiation alone Since the underlying immunodeficiency state is not affected by therapy directed against the lymphoma patients are still prone to life-threatening opportunistic infections or relapse of lymphomatous disease within the CNS Accordingly AZT will also be used in an attempt to alter the overall natural history of the disease
Detailed Description:
Results of radiation given to patients with AIDS-related high-grade CNS lymphoma have been disappointing with short survival times due to infection complications However complete response has been documented after radiation in some patients High-dose MTX will be used to improve the possibility of a greater antineoplastic response than that obtained by radiation alone Since the underlying immunodeficiency state is not affected by therapy directed against the lymphoma patients are still prone to life-threatening opportunistic infections or relapse of lymphomatous disease within the CNS Accordingly AZT will also be used in an attempt to alter the overall natural history of the disease
Radiation begins on day 1 of therapy Patients receive dexamethasone orally PO or by intravenous injection IV on days 1-10 MTX IV over 6 hours weekly for a total of 4 doses starts 1 week after completion of the cranial radiation Leucovorin LCV IV or PO begins 6 hours after MTX has been completed over 6 hours for 8 doses AZT while awake starts on day 1 of therapy and continues for 52 weeks Patients are reevaluated with computerized tomography CT or magnetic resonance imaging MRI scan of the brain at conclusion of radiation therapy and systemic treatment 6 and 10 weeks respectively If there is a complete or partial response CR or PR patient will remain on study and continue to receive AZT if stable disease or no response patient will be taken off study Reevaluation at 16 weeks from start of study will be done If CR or PR the patient will continue AZT for 1 year If there is no change or progression of disease or if the patient develops evidence of systemic lymphomatous disease patient will be taken off study
Radiation begins on day 1 of therapy Patients receive dexamethasone orally PO or by intravenous injection IV on days 1-10 MTX IV over 6 hours weekly for a total of 4 doses starts 1 week after completion of the cranial radiation Leucovorin LCV IV or PO begins 6 hours after MTX has been completed over 6 hours for 8 doses AZT while awake starts on day 1 of therapy and continues for 52 weeks Patients are reevaluated with computerized tomography CT or magnetic resonance imaging MRI scan of the brain at conclusion of radiation therapy and systemic treatment 6 and 10 weeks respectively If there is a complete or partial response CR or PR patient will remain on study and continue to receive AZT if stable disease or no response patient will be taken off study Reevaluation at 16 weeks from start of study will be done If CR or PR the patient will continue AZT for 1 year If there is no change or progression of disease or if the patient develops evidence of systemic lymphomatous disease patient will be taken off study
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 |
|---|---|---|---|
| 10985 | REGISTRY | DAIDS ES Registry Number | None |