AIDS-related Peripheral/Systemic Lymphoma Clinical Trial
Official title:
Randomized, Phase II Trial of CHOP vs. Oral Chemotherapy With Concomitant Antiretroviral Therapy in Patients With HIV-Associated Lymphoma in Sub-Saharan Africa
This randomized phase II trial studies how well intravenous (IV) chemotherapy or oral chemotherapy works in treating patients with previously untreated stage III-IV human immunodeficiency virus (HIV)-associated non-Hodgkin lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone, lomustine, etoposide, and procarbazine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells
PRIMARY OBJECTIVES: I. To compare the efficacy of standard cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP) and an oral chemotherapy regimen for acquired immune deficiency syndrome (AIDS)-related (AR)-non-Hodgkin lymphoma (NHL) in sub-Saharan Africa with respect to overall survival (OS). SECONDARY OBJECTIVES: I. To compare the objectives response rate (ORR) of persons randomized to CHOP and oral chemotherapy. II. To compare the progression free survival (PFS) of persons randomized to CHOP and oral chemotherapy. III. To compare the safety and tolerance of persons randomized to CHOP and oral chemotherapy. TERTIARY OBJECTIVES: I. To describe the rates of completion of therapy of persons randomized to CHOP and oral chemotherapy. II. To describe adherence to chemotherapy of persons randomized to CHOP and oral chemotherapy. III. To describe adherence to antiretroviral therapy of persons randomized to CHOP and oral chemotherapy. IV. To describe the effects of therapy on HIV control, as measured by cluster of differentiation (CD)4 counts and HIV viral load. V. To investigate correlates of survival. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive CHOP chemotherapy comprising cyclophosphamide intravenously (IV) on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone orally (PO) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive lomustine PO once daily (QD) on day 1 (courses 1 and 3 only), etoposide PO QD on days 1-3, cyclophosphamide PO QD on days 22-26, and procarbazine hydrochloride PO QD on days 22-26. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 3, 6, 12, 18, and 24 months. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00004241 -
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma
|
Phase 1 | |
| Terminated |
NCT00096005 -
Tanespimycin and Bortezomib in Treating Patients With Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
| Completed |
NCT00022555 -
Bryostatin 1 Plus Vincristine in Treating Patients With Recurrent or Refractory HIV-Related Lymphoma
|
Phase 1 | |
| Completed |
NCT00112593 -
Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer
|
N/A | |
| Completed |
NCT00049036 -
Combination Chemotherapy and Rituximab in Treating Patients With HIV-Associated Stage I, Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
|
Phase 2 | |
| Completed |
NCT01158274 -
RO4929097 and Capecitabine in Treating Patients With Refractory Solid Tumors
|
Phase 1 | |
| Terminated |
NCT00036855 -
Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma
|
Phase 1 | |
| Completed |
NCT00003970 -
Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma
|
Phase 1 | |
| Withdrawn |
NCT01769911 -
Genetically Modified Peripheral Blood Stem Cell Transplant in Treating Patients With HIV-Associated Non-Hodgkin or Hodgkin Lymphoma
|
N/A | |
| Completed |
NCT00077155 -
Cilengitide (EMD 121974) in Treating Patients With Advanced Solid Tumors or Lymphoma
|
Phase 1 | |
| Completed |
NCT00025415 -
Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction
|
Phase 1 | |
| Completed |
NCT00005811 -
Topotecan Hydrochloride in Treating Children With Meningeal Cancer That Has Not Responded to Previous Treatment
|
Phase 2 |