A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma
NCT ID: NCT00000658
Last Updated: 2021-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
250 participants
INTERVENTIONAL
1996-02-29
Brief Summary
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HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.
Detailed Description
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Patients are randomized to one of two treatment groups. Patients are stratified for (1) presence or absence of a prior AIDS diagnosis, (2) Karnofsky performance status of 70 or greater and lower than 70. Treatment includes prophylaxis for meningeal lymphoma and Pneumocystis carinii pneumonia. Patients on low-dose mBACOD who experience neutropenia may be given rGM-CSF until the absolute neutrophil count improves. AZT may be initiated at the completion of chemotherapy for all patients in complete remission at that time.
PER AMENDMENT 5/30/95: This trial was closed to accrual on 11/7/94 on the recommendation of the Data and Safety Monitoring Board (DSMB), because the non-significant difference in survival between the 2 treatment groups was not expected to change with further enrollment.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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Bleomycin sulfate
Vincristine sulfate
Doxorubicin hydrochloride
Cyclophosphamide
Allopurinol
Methotrexate
Cytarabine
Leucovorin calcium
Sargramostim
Dexamethasone
Eligibility Criteria
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Inclusion Criteria
Required:
* PCP prophylaxis with Bactrim, aerosolized pentamidine, or dapsone.
Allowed:
ddI, except when patient is also taking allopurinol.
Patients must have the following:
* Diagnosis of HIV seropositivity and non-Hodgkin's lymphoma.
* Ability to give informed consent and willingness to comply with all procedures and visit schedule.
* If between ages of 12 and 18 must receive care under direct supervision of a pediatric oncologist, and have consent of parent, guardian, or person with power of attorney.
* Participation in clinical trials of other antiretroviral agents is at the discretion of the investigator and individual patient.
Exclusion Criteria
Patients with the following conditions or symptoms are excluded:
* Active opportunistic infection, excluding Mycobacterium avium complex, requiring antibiotic therapy.
* Another prior or current malignancy, excepting curatively treated cervical or basal cell carcinoma.
* Kaposi's sarcoma if rapidly progressive, with visceral involvement, or causing peripheral edema.
* Primary central nervous system lymphoma.
Concurrent Medication:
Excluded:
* Zidovudine (AZT) or any antiretroviral agent unless allowed by investigator. ddI is allowed except when also taking allopurinol.
Systemic myelosuppressive drugs, including trimethoprim/sulfamethoxazole (T/S), pyrimethamine/sulfa, or ganciclovir.
\-
Patients with the following are excluded:
* Active opportunistic infection, excluding Mycobacterium avium complex, requiring antibiotic therapy.
* Another prior or current malignancy, excepting curatively treated cervical or basal cell carcinoma.
* Kaposi's sarcoma if rapidly progressive, with visceral involvement, or causing peripheral edema.
* Primary central nervous system lymphoma.
Prior Medication:
Excluded:
* Immunomodulating agents within 2 weeks of study entry.
Prior Treatment:
Excluded:
* Chemotherapy.
Radiation therapy as outlined in protocol.
12 Years
ALL
No
Sponsors
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Schering-Plough
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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L Kaplan
Role: STUDY_CHAIR
AA Levine
Role: STUDY_CHAIR
DJ Straus
Role: STUDY_CHAIR
Locations
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USC CRS
Los Angeles, California, United States
UCLA CARE Center CRS
Los Angeles, California, United States
Ucsf Aids Crs
San Francisco, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
Northwestern University CRS
Chicago, Illinois, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, United States
Bmc Actg Crs
Boston, Massachusetts, United States
Washington U CRS
St Louis, Missouri, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, United States
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, United States
NY Univ. HIV/AIDS CRS
New York, New York, United States
Memorial Sloan-Kettering Cancer Ctr.
New York, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
Unc Aids Crs
Chapel Hill, North Carolina, United States
Case CRS
Cleveland, Ohio, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States
Pitt CRS
Pittsburgh, Pennsylvania, United States
Countries
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References
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Kaplan LD, Straus DJ, Testa MA, Von Roenn J, Dezube BJ, Cooley TP, Herndier B, Northfelt DW, Huang J, Tulpule A, Levine AM. Low-dose compared with standard-dose m-BACOD chemotherapy for non-Hodgkin's lymphoma associated with human immunodeficiency virus infection. National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group. N Engl J Med. 1997 Jun 5;336(23):1641-8. doi: 10.1056/NEJM199706053362304.
Kaplan L, et al. Randomized trial of standard dose mBACOD with GM-CSF vs reduced dose mBACOD for systemic HIV-associated lymphoma: ACTG 142. Proc Annu Meet Am Assoc Cancer Res. 1995;14:A818
Straus DJ, Huang J, Testa MA, Levine AM, Kaplan LD. Prognostic factors in the treatment of human immunodeficiency virus-associated non-Hodgkin's lymphoma: analysis of AIDS Clinical Trials Group protocol 142--low-dose versus standard-dose m-BACOD plus granulocyte-macrophage colony-stimulating factor. National Institute of Allergy and Infectious Diseases. J Clin Oncol. 1998 Nov;16(11):3601-6. doi: 10.1200/JCO.1998.16.11.3601.
Other Identifiers
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11117
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 142
Identifier Type: -
Identifier Source: org_study_id