Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002571
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
1999-11-01
Brief Title:
SWOG-9320 Combination Chemotherapy Radiation Therapy and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Study of Promace-Cytabom With Trimethoprim Sulfamethoxazole Zidovudine AZT and Granulocyte Colony Stimulating Factor G-CSF in Patients With AIDS-Related Lymphoma Phase II
Status:
COMPLETED
Status Verified Date:
2013-01
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage cancer cells Antiviral therapy may be effective treatment for AIDS-related lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy radiation therapy and antiviral therapy in treating patients who have AIDS-related lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy radiation therapy and antiviral therapy in treating patients who have AIDS-related lymphoma
Detailed Description:
OBJECTIVES I Assess the response rate of AIDS-related lymphoma to ProMACE-CytaBOM cyclophosphamide doxorubicin etoposide prednisone cytarabine bleomycin vincristine methotrexate II Assess the toxic effects of ProMACE-CytaBOM in patients with AIDS-related lymphoma III Evaluate whether the incorporation of filgrastim G-CSF into the regimen allows treatment with full doses of the myelotoxic agents in these patients IV Determine whether intensive CNS treatment with intrathecal cytarabine and whole-brain irradiation prevents meningeal relapse or controls meningeal lymphomatous involvement in these patients
OUTLINE Patients are stratified according to participating institution and descriptive factors histopathology diffuse large cleavednoncleaved and immunoblastic lymphomas vs all others CD4 count less than 50 vs 50 or more cellsmm3 prior opportunistic infection yes vs no performance status 0 and 1 vs 2 concurrent AZT yes vs no concurrent protease inhibitors yes vs no marrow involvement yes vs no Patients receive ProMACE-CytaBOM regimen as follows Cyclophosphamide doxorubicin and etoposide IV on day 1 Cytarabine bleomycin vincristine and methotrexate IV on day 8 Oral prednisone on days 1-14 Oral leucovorin calcium every 6 hours for 4 doses on day 9 Patients also receive filgrastim G-CSF subcutaneously on days 9-20 and oral co-trimoxazole 3 days a week throughout treatment plus antiretroviral therapy at the discretion of the treating physician Treatment repeats every 21 days for a maximum of 6 courses Patients with progressive disease are removed from study after 2 courses Remaining patients receive an additional 2 treatment courses and are then restaged Patients without stable or progressive disease receive 2 more courses in the absence of unacceptable toxicity Patients with positive bone marrow at study entry receive CNS prophylaxis with 5 evenly spaced doses of intrathecal cytarabine during the first 2 treatment courses and on day 1 of each subsequent course Patients with positive CSF cytology at study entry receive intrathecal cytarabine on days 1-5 of the first treatment course and on day 1 of each subsequent course if CSF negative after 5 daily doses Patients whose CSF remains positive after 5 days receive 5 evenly spaced doses of intrathecal methotrexate during the second treatment course Patients with negative bone marrow and CSF cytology at study entry receive 5 evenly spaced doses of intrathecal cytarabine within 1 month of systemic therapy All patients achieving a complete or partial response following systemic therapy and intrathecal cytarabine receive cranial irradiation to all meningeal surfaces Patients are followed monthly for 1 year every 2 months for 1 year every 3 months for 1 year then annually thereafter
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study over approximately 2 years
OUTLINE Patients are stratified according to participating institution and descriptive factors histopathology diffuse large cleavednoncleaved and immunoblastic lymphomas vs all others CD4 count less than 50 vs 50 or more cellsmm3 prior opportunistic infection yes vs no performance status 0 and 1 vs 2 concurrent AZT yes vs no concurrent protease inhibitors yes vs no marrow involvement yes vs no Patients receive ProMACE-CytaBOM regimen as follows Cyclophosphamide doxorubicin and etoposide IV on day 1 Cytarabine bleomycin vincristine and methotrexate IV on day 8 Oral prednisone on days 1-14 Oral leucovorin calcium every 6 hours for 4 doses on day 9 Patients also receive filgrastim G-CSF subcutaneously on days 9-20 and oral co-trimoxazole 3 days a week throughout treatment plus antiretroviral therapy at the discretion of the treating physician Treatment repeats every 21 days for a maximum of 6 courses Patients with progressive disease are removed from study after 2 courses Remaining patients receive an additional 2 treatment courses and are then restaged Patients without stable or progressive disease receive 2 more courses in the absence of unacceptable toxicity Patients with positive bone marrow at study entry receive CNS prophylaxis with 5 evenly spaced doses of intrathecal cytarabine during the first 2 treatment courses and on day 1 of each subsequent course Patients with positive CSF cytology at study entry receive intrathecal cytarabine on days 1-5 of the first treatment course and on day 1 of each subsequent course if CSF negative after 5 daily doses Patients whose CSF remains positive after 5 days receive 5 evenly spaced doses of intrathecal methotrexate during the second treatment course Patients with negative bone marrow and CSF cytology at study entry receive 5 evenly spaced doses of intrathecal cytarabine within 1 month of systemic therapy All patients achieving a complete or partial response following systemic therapy and intrathecal cytarabine receive cranial irradiation to all meningeal surfaces Patients are followed monthly for 1 year every 2 months for 1 year every 3 months for 1 year then annually thereafter
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study over approximately 2 years
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 |
|---|---|---|---|
| SWOG-9320 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |