Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000801
Status:
COMPLETED
Last Update Posted:
2012-11-01
First Post:
1999-11-02
Brief Title:
Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma
Status:
COMPLETED
Status Verified Date:
2012-10
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 estimate the response rate overall and disease-free survival toxicities factors associated with outcome and effect on quality of life in patients with AIDS-related primary CNS lymphoma treated with CHOD cyclophosphamide doxorubicin vincristine and dexamethasone plus filgrastim granulocyte-colony stimulating factor G-CSF and external beam irradiation To determine other clinical markers present in this patient population
Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS lymphoma
Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS lymphoma
Detailed Description:
Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS lymphoma
Patients who upon staging workup are found to be without systemic involvement undergo one cycle of chemotherapy with cyclophosphamide doxorubicin vincristine dexamethasone and G-CSF Cyclophosphamide doxorubicin and vincristine are administered intravenously on day 1 Dexamethasone is administered intravenously on day 1 and then orally thereafter with gradual discontinuation G-CSF is administered subcutaneously daily beginning on day 2 and continuing for a total of 10 days or until blood counts have recovered to an acceptable level Patients with evidence of cancer cells in their cerebrospinal fluid CSF will receive chemotherapy with intrathecal cytarabine twice weekly until no further evidence of cancer cells is found in the CSF then once weekly for 6 weeks and then monthly for 10 months Seven to ten days following completion of one cycle of chemotherapy patients undergo radiotherapy to the brain at a dose of 25 Gy daily for 5 days per week for approximately 4 weeks Total dose to the whole brain and meninges is 300 Gy in 12 fractions and total dose to the primary boost volume is 100 Gy in 4 fractions During therapy blood is drawn weekly and brain scans are performed every 3-12 weeks An initial CSF sample will be obtained by lumbar puncture
Patients who upon staging workup are found to be without systemic involvement undergo one cycle of chemotherapy with cyclophosphamide doxorubicin vincristine dexamethasone and G-CSF Cyclophosphamide doxorubicin and vincristine are administered intravenously on day 1 Dexamethasone is administered intravenously on day 1 and then orally thereafter with gradual discontinuation G-CSF is administered subcutaneously daily beginning on day 2 and continuing for a total of 10 days or until blood counts have recovered to an acceptable level Patients with evidence of cancer cells in their cerebrospinal fluid CSF will receive chemotherapy with intrathecal cytarabine twice weekly until no further evidence of cancer cells is found in the CSF then once weekly for 6 weeks and then monthly for 10 months Seven to ten days following completion of one cycle of chemotherapy patients undergo radiotherapy to the brain at a dose of 25 Gy daily for 5 days per week for approximately 4 weeks Total dose to the whole brain and meninges is 300 Gy in 12 fractions and total dose to the primary boost volume is 100 Gy in 4 fractions During therapy blood is drawn weekly and brain scans are performed every 3-12 weeks An initial CSF sample will be obtained by lumbar puncture
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 |
|---|---|---|---|
| ECOG E 1493 | None | None | None |