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
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To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL).
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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma, Non-Hodgkin HIV Infections |
Drug: Bleomycin sulfate Drug: Vincristine sulfate Drug: Doxorubicin hydrochloride Drug: Cyclophosphamide Drug: Allopurinol Drug: Methotrexate Drug: Cytarabine Drug: Leucovorin calcium Drug: Sargramostim Drug: Dexamethasone |
Phase 3 |
Study Type: | Interventional |
Study Design: | Masking: Open Label Primary Purpose: Treatment |
Official Title: | 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 |
Estimated Enrollment: | 250 |
Study Completion Date: | February 1996 |
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.
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.
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
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
Co-existing Condition:
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.
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United States, California | |
UCLA CARE Center CRS | |
Los Angeles, California, United States, 90095 | |
USC CRS | |
Los Angeles, California, United States, 900331079 | |
Ucsf Aids Crs | |
San Francisco, California, United States, 941102859 | |
United States, Colorado | |
University of Colorado Hospital CRS | |
Aurora, Colorado, United States, 80262 | |
United States, Illinois | |
Northwestern University CRS | |
Chicago, Illinois, United States, 60611 | |
Rush Univ. Med. Ctr. ACTG CRS | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
Indiana Univ. School of Medicine, Infectious Disease Research Clinic | |
Indianapolis, Indiana, United States, 462025250 | |
United States, Maryland | |
Johns Hopkins Adult AIDS CRS | |
Baltimore, Maryland, United States | |
United States, Massachusetts | |
Beth Israel Deaconess - East Campus A0102 CRS | |
Boston, Massachusetts, United States, 02215 | |
Beth Israel Deaconess Med. Ctr., ACTG CRS | |
Boston, Massachusetts, United States, 02118 | |
Bmc Actg Crs | |
Boston, Massachusetts, United States | |
United States, Missouri | |
Washington U CRS | |
St. Louis, Missouri, United States | |
United States, New York | |
SUNY - Buffalo, Erie County Medical Ctr. | |
Buffalo, New York, United States, 14215 | |
Beth Israel Med. Ctr. (Mt. Sinai) | |
New York, New York, United States, 02215 | |
Memorial Sloan-Kettering Cancer Ctr. | |
New York, New York, United States, 10021 | |
NY Univ. HIV/AIDS CRS | |
New York, New York, United States, 10016 | |
Univ. of Rochester ACTG CRS | |
Rochester, New York, United States, 14642 | |
United States, North Carolina | |
Unc Aids Crs | |
Chapel Hill, North Carolina, United States, 275997215 | |
United States, Ohio | |
Case CRS | |
Cleveland, Ohio, United States | |
The Ohio State Univ. AIDS CRS | |
Columbus, Ohio, United States, 432101228 | |
United States, Pennsylvania | |
Hosp. of the Univ. of Pennsylvania CRS | |
Philadelphia, Pennsylvania, United States, 19104 | |
Pitt CRS | |
Pittsburgh, Pennsylvania, United States, 15213 |
Study Chair: | L Kaplan | |
Study Chair: | AA Levine | |
Study Chair: | DJ Straus |
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Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000658 History of Changes |
Other Study ID Numbers: | ACTG 142, 11117 |
Study First Received: | November 2, 1999 |
Last Updated: | April 26, 2012 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
M-BACOD protocol Granulocyte-Macrophage Colony-Stimulating Factor Acquired Immunodeficiency Syndrome Allopurinol Antineoplastic Agents, Combined |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lymphoma Lymphoma, Non-Hodgkin Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Allopurinol BB 1101 Methotrexate Cytarabine Cyclophosphamide Antineoplastic Agents Bleomycin Dexamethasone Doxorubicin Vincristine Dexamethasone acetate Dexamethasone 21-phosphate |
ClinicalTrials.gov processed this record on February 21, 2013