Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000703
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
Chemotherapy and Azidothymidine With or Without Radiotherapy for High Grade Lymphoma in AIDS-Risk Group Members
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Chemotherapy and Azidothymidine With or Without Radiotherapy for High Grade Lymphoma in AIDS-Risk Group Members
Status:
COMPLETED
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 effectiveness of a combination chemotherapy-radiation-zidovudine AZT treatment for patients with peripheral lymphoma
Other chemotherapies have been tried in patients with AIDS related lymphomas but the results have not been satisfactory This study will show whether the combination of chemotherapy radiation and AZT is more effective and less toxic than previously used treatments
Other chemotherapies have been tried in patients with AIDS related lymphomas but the results have not been satisfactory This study will show whether the combination of chemotherapy radiation and AZT is more effective and less toxic than previously used treatments
Detailed Description:
Other chemotherapies have been tried in patients with AIDS related lymphomas but the results have not been satisfactory This study will show whether the combination of chemotherapy radiation and AZT is more effective and less toxic than previously used treatments
All patients will receive combination chemotherapy and AZT The combination chemotherapy will be repeated every 3 to 4 weeks for a maximum total of 6 cycles Each cycle will consist of doxorubicin bleomycin cyclophosphamide and vincristine on day 1 dexamethasone on days 1-5 and methotrexate on day 15 Patients with meningeal or bone marrow disease will receive radiation and intrathecal cytarabine ARA-C while those without will receive ARA-C without radiation Patients with documented lymphomas in the central nervous system at initial workup will start radiation as soon as possible and intrathecal ARA-C tiw until cerebrospinal fluid is clear then every month for 1 year patients with normal lumbar puncture brain scan and bone marrow at first diagnosis will begin radiation on day 1 of cycle 3 of chemotherapy Lumbar punctures for evaluation will be done four times during the first cycle on days 1 8 21 and 28 AZT will be administered every 4 hours 7 days a week beginning at the completion of combined chemotherapy once the patient has achieved a complete remission of the lymphoma and continuing for 1 year
All patients will receive combination chemotherapy and AZT The combination chemotherapy will be repeated every 3 to 4 weeks for a maximum total of 6 cycles Each cycle will consist of doxorubicin bleomycin cyclophosphamide and vincristine on day 1 dexamethasone on days 1-5 and methotrexate on day 15 Patients with meningeal or bone marrow disease will receive radiation and intrathecal cytarabine ARA-C while those without will receive ARA-C without radiation Patients with documented lymphomas in the central nervous system at initial workup will start radiation as soon as possible and intrathecal ARA-C tiw until cerebrospinal fluid is clear then every month for 1 year patients with normal lumbar puncture brain scan and bone marrow at first diagnosis will begin radiation on day 1 of cycle 3 of chemotherapy Lumbar punctures for evaluation will be done four times during the first cycle on days 1 8 21 and 28 AZT will be administered every 4 hours 7 days a week beginning at the completion of combined chemotherapy once the patient has achieved a complete remission of the lymphoma and continuing for 1 year
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 |
|---|---|---|---|
| 10984 | REGISTRY | DAIDS ES Registry Number | None |