Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002524
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Pilot Study in AIDS-Related Lymphomas
Status:
COMPLETED
Status Verified Date:
2012-07
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 Combining more than one drug may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma
Detailed Description:
OBJECTIVES I Develop an effective chemotherapy regimen with mild immunosuppressive and myelosuppressive properties to treat patients with AIDS-related lymphoma ARL who have severe T4 lymphopenia II Estimate the CR rate lymphoma-free survival and overall survival of non-T4 lymphopenic patients and patients who present with nonbulky Ann Arbor stage I ARL treated with standard regimens of known effectiveness III Evaluate the effects on long-term outlook of concurrent antiretroviral therapy prophylactic antibiosis with trimethoprimsulfamethoxazole or aerosolized pentamidine and prn use of granulocyte colony-stimulating factor for severe myelosuppression
OUTLINE Patients are assigned to Regimens A B and C according to histology and extent of disease and the degree of immunosuppression as follows Regimen A Patients with Ann Arbor stage I intermediate grade or immunoblastic lymphoma with measurable nonbulky disease less than 7 cm low LDH less than 686 and no prior opportunistic infection irrespective of T4 count also those with nonmeasurable stage I extranodal primaries infiltration of less than 23 of an organ site eg stomach rectum esophagus sinus cavity irrespective of T4 count Regimen B All patients except primary brain lymphoma patients not assigned to Regimen A who have T4 counts of at least 200 and no history of opportunistic infection includes all stages of small noncleaved cell lymphoma and bulky stage I and stages II-IV intermediate grade and immunoblastic lymphoma Regimen C Patients not assigned to Regimen A or B ie those with T4 counts less than 200 andor a history of opportunistic infection and those with primary brain lymphoma The following acronyms are used ARA-C Cytarabine NSC-63878 BLEO Bleomycin NSC-125066 CDDP Cisplatin NSC-119875 CF Leucovorin calcium NSC-3590 CTX Cyclophosphamide NSC-26271 DOX Doxorubicin NSC-123127 5-FU Fluorouracil NSC-19893 G-CSF Granulocyte Colony-Stimulating Factor Amgen NSC-614629 IFF Ifosfamide NSC-109723 MePRDL Methylprednisolone succinate Mesna Mercaptoethane sulfonate NSC-113891 MTX Methotrexate NSC-740 PRED Prednisone NSC-10023 VCR Vincristine NSC-67574 VP-16 Etoposide NSC-141540 ZDV Zidovudine NSC-602670 Regimen A 5-Drug Combination Chemotherapy followed by Radiotherapy CHOP-BLEO CTX DOX VCR PRED BLEO followed by involved-field irradiation with megavoltage equipment Regimen B 4-Drug Combination Chemotherapy alternating with 3-Drug Combination Chemotherapy followed as indicated by Radiotherapy ASHAP DOX MePRDL ARA-C CDDP alternating with IMVP-16 IFFMesna MTXCF VP-16 followed in selected patients with initially bulky localized disease by involved-field irradiation with megavoltage equipment Regimen C 2-Drug Combination Chemotherapy with Drug Modulation followed as indicated by Radiotherapy FLEP 5-FUCFCDDP followed in selected patients with initially bulky localized disease by involved-field irradiation with megavoltage equipment Prior to starting chemotherapy patients with primary brain lymphoma receive a course of cranial irradiation using accelerator beams with photon energies of 6-15 MV
PROJECTED ACCRUAL Up to 92 patients 10 for Regimen A 28 for Regimen B 54 for Regimen C will be entered over 3 years If there are no CRs among the first 6 patients on Regimens A and B or the first 19 patients on Regimen C accrual to that regimen will cease If more than 4 infectious deaths occur among the first 10 patients or if the rate of disease progression exceeds 20 on any regimen further accrual to that regimen will cease
OUTLINE Patients are assigned to Regimens A B and C according to histology and extent of disease and the degree of immunosuppression as follows Regimen A Patients with Ann Arbor stage I intermediate grade or immunoblastic lymphoma with measurable nonbulky disease less than 7 cm low LDH less than 686 and no prior opportunistic infection irrespective of T4 count also those with nonmeasurable stage I extranodal primaries infiltration of less than 23 of an organ site eg stomach rectum esophagus sinus cavity irrespective of T4 count Regimen B All patients except primary brain lymphoma patients not assigned to Regimen A who have T4 counts of at least 200 and no history of opportunistic infection includes all stages of small noncleaved cell lymphoma and bulky stage I and stages II-IV intermediate grade and immunoblastic lymphoma Regimen C Patients not assigned to Regimen A or B ie those with T4 counts less than 200 andor a history of opportunistic infection and those with primary brain lymphoma The following acronyms are used ARA-C Cytarabine NSC-63878 BLEO Bleomycin NSC-125066 CDDP Cisplatin NSC-119875 CF Leucovorin calcium NSC-3590 CTX Cyclophosphamide NSC-26271 DOX Doxorubicin NSC-123127 5-FU Fluorouracil NSC-19893 G-CSF Granulocyte Colony-Stimulating Factor Amgen NSC-614629 IFF Ifosfamide NSC-109723 MePRDL Methylprednisolone succinate Mesna Mercaptoethane sulfonate NSC-113891 MTX Methotrexate NSC-740 PRED Prednisone NSC-10023 VCR Vincristine NSC-67574 VP-16 Etoposide NSC-141540 ZDV Zidovudine NSC-602670 Regimen A 5-Drug Combination Chemotherapy followed by Radiotherapy CHOP-BLEO CTX DOX VCR PRED BLEO followed by involved-field irradiation with megavoltage equipment Regimen B 4-Drug Combination Chemotherapy alternating with 3-Drug Combination Chemotherapy followed as indicated by Radiotherapy ASHAP DOX MePRDL ARA-C CDDP alternating with IMVP-16 IFFMesna MTXCF VP-16 followed in selected patients with initially bulky localized disease by involved-field irradiation with megavoltage equipment Regimen C 2-Drug Combination Chemotherapy with Drug Modulation followed as indicated by Radiotherapy FLEP 5-FUCFCDDP followed in selected patients with initially bulky localized disease by involved-field irradiation with megavoltage equipment Prior to starting chemotherapy patients with primary brain lymphoma receive a course of cranial irradiation using accelerator beams with photon energies of 6-15 MV
PROJECTED ACCRUAL Up to 92 patients 10 for Regimen A 28 for Regimen B 54 for Regimen C will be entered over 3 years If there are no CRs among the first 6 patients on Regimens A and B or the first 19 patients on Regimen C accrual to that regimen will cease If more than 4 infectious deaths occur among the first 10 patients or if the rate of disease progression exceeds 20 on any regimen further accrual to that regimen will cease
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 |
|---|---|---|---|
| CDR0000078316 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| MDA-DM-93058 | OTHER | None | None |
| NCI-T93-0088D | None | None | None |