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

NCT00000658 | Completed Phase 3

• 2 other identifiers: ACTG 14211117
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 22

Brief Summary

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.

Conditions

Lymphoma, Non-Hodgkin; HIV Infections

Keywords

M-BACOD protocol; Granulocyte-Macrophage Colony-Stimulating Factor; Acquired Immunodeficiency Syndrome; Allopurinol; Antineoplastic Agents, Combined

Interventions

Bleomycin sulfate DRUG

Vincristine sulfate DRUG

Doxorubicin hydrochloride DRUG

Cyclophosphamide DRUG

Allopurinol DRUG

Methotrexate DRUG

Cytarabine DRUG

Leucovorin calcium DRUG

Sargramostim DRUG

Dexamethasone DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Schering-Plough: collaborator

Study Sites (22)

USC CRS

Los Angeles, California, 900331079, United States

Location

UCLA CARE Center CRS

Los Angeles, California, 90095, United States

Location

Ucsf Aids Crs

San Francisco, California, 941102859, United States

Location

University of Colorado Hospital CRS

Aurora, Colorado, 80262, United States

Location

Northwestern University CRS

Chicago, Illinois, 60611, United States

Location

Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, 60612, United States

Location

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, 462025250, United States

Location

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, United States

Location

Beth Israel Deaconess Med. Ctr., ACTG CRS

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess - East Campus A0102 CRS

Boston, Massachusetts, 02215, United States

Location

Bmc Actg Crs

Boston, Massachusetts, United States

Location

Washington U CRS

St Louis, Missouri, United States

Location

SUNY - Buffalo, Erie County Medical Ctr.

Buffalo, New York, 14215, United States

Location

Beth Israel Med. Ctr. (Mt. Sinai)

New York, New York, 02215, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016, United States

Location

Memorial Sloan-Kettering Cancer Ctr.

New York, New York, 10021, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, 14642, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 275997215, United States

Location

Case CRS

Cleveland, Ohio, United States

Location

The Ohio State Univ. AIDS CRS

Columbus, Ohio, 432101228, United States

Location

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, 19104, United States

Location

Pitt CRS

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

• 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.

  PMID: 9171066 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 9817281 BACKGROUND

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Bleomycin; Vincristine; Doxorubicin; Cyclophosphamide; Allopurinol; Methotrexate; Cytarabine; Leucovorin; sargramostim; Dexamethasone

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Purines; Aminopterin; Pterins; Pteridines; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Coenzymes; Enzymes and Coenzymes; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Officials

• L Kaplan

  STUDY CHAIR

• AA Levine

  STUDY CHAIR

• DJ Straus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: February 1, 1996
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

US (22)