Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000689
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
1999-11-02
Brief Title:
Phase I Trial of mBACOD and Granulocyte-Macrophage Colony-Stimulating Factor GM-CSF in AIDS-Associated Large Cell Immunoblastic and Small Non-cleaved Lymphoma
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase I Trial of mBACOD and Granulocyte-Macrophage Colony-Stimulating Factor GM-CSF in AIDS-Associated Large Cell Immunoblastic and Small Non-cleaved Lymphoma
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 toxicity and effectiveness of adding sargramostim recombinant granulocyte-macrophage colony stimulating factor GM-CSF to a standard chemotherapy drug combination methotrexate bleomycin doxorubicin cyclophosphamide vincristine and dexamethasone known as mBACOD in the treatment of non-Hodgkins lymphoma in patients who are infected with HIV
Treatment of patients with AIDS-associated lymphoma is achieving inferior results when compared with outcomes for non-AIDS patients Treatment with mBACOD has been promising but the toxicity is very high Patients treated with mBACOD have very low white blood cell counts GM-CSF has increased the number of white blood cells in animal studies and preliminary human studies It is hoped that including GM-CSF among the drugs given to lymphoma patients will prevent or lessen the decrease in white blood cells caused by mBACOD
Treatment of patients with AIDS-associated lymphoma is achieving inferior results when compared with outcomes for non-AIDS patients Treatment with mBACOD has been promising but the toxicity is very high Patients treated with mBACOD have very low white blood cell counts GM-CSF has increased the number of white blood cells in animal studies and preliminary human studies It is hoped that including GM-CSF among the drugs given to lymphoma patients will prevent or lessen the decrease in white blood cells caused by mBACOD
Detailed Description:
Treatment of patients with AIDS-associated lymphoma is achieving inferior results when compared with outcomes for non-AIDS patients Treatment with mBACOD has been promising but the toxicity is very high Patients treated with mBACOD have very low white blood cell counts GM-CSF has increased the number of white blood cells in animal studies and preliminary human studies It is hoped that including GM-CSF among the drugs given to lymphoma patients will prevent or lessen the decrease in white blood cells caused by mBACOD
Patients admitted to the study receive chemotherapy in 21-day cycles The length of therapy 2 - 8 months depends on how the tumor responds to treatment Four medicines are given on day 1 of each cycle by vein IV doxorubicin cyclophosphamide bleomycin vincristine Dosages of doxorubicin and cyclophosphamide are increased in later groups of patients if toxicity in the first group is tolerable A fifth medicine dexamethasone is given by mouth PO on days 1 - 5 of each cycle and the sixth medicine methotrexate is given IV on day 15 of each cycle Leucovorin is given after methotrexate to prevent methotrexate side effects GM-CSF treatment is started on day 3 and continued for 11 days To prevent the spread of the tumor a spinal tap is done on 4 occasions to inject cytosine arabinoside directly into the spinal fluid If tumor cells are present in the spinal fluid the patient also takes cytosine arabinoside by spinal tap 3 xweek until the tumor cells disappear and then at monthly intervals for 1 year Patients with tumor cells in the spinal fluid are also given radiation treatment to the head
Patients admitted to the study receive chemotherapy in 21-day cycles The length of therapy 2 - 8 months depends on how the tumor responds to treatment Four medicines are given on day 1 of each cycle by vein IV doxorubicin cyclophosphamide bleomycin vincristine Dosages of doxorubicin and cyclophosphamide are increased in later groups of patients if toxicity in the first group is tolerable A fifth medicine dexamethasone is given by mouth PO on days 1 - 5 of each cycle and the sixth medicine methotrexate is given IV on day 15 of each cycle Leucovorin is given after methotrexate to prevent methotrexate side effects GM-CSF treatment is started on day 3 and continued for 11 days To prevent the spread of the tumor a spinal tap is done on 4 occasions to inject cytosine arabinoside directly into the spinal fluid If tumor cells are present in the spinal fluid the patient also takes cytosine arabinoside by spinal tap 3 xweek until the tumor cells disappear and then at monthly intervals for 1 year Patients with tumor cells in the spinal fluid are also given radiation treatment to the head
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 |
|---|---|---|---|
| 11048 | REGISTRY | DAIDS ES Registry Number | None |