Know Cancer

or
forgot password

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


Phase 3
12 Years
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin, HIV Infections

Thank you

Trial Information

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


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.

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

L Kaplan

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 142

NCT ID:

NCT00000658

Start Date:

Completion Date:

February 1996

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • HIV Infections
  • M-BACOD protocol
  • Granulocyte-Macrophage Colony-Stimulating Factor
  • Acquired Immunodeficiency Syndrome
  • Allopurinol
  • Antineoplastic Agents, Combined
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

UCLA CARE Center CRSLos Angeles, California  90095
USC CRSLos Angeles, California  90033
Ucsf Aids CrsSan Francisco, California  
University of Colorado Hospital CRSAurora, Colorado  80262
Northwestern University CRSChicago, Illinois  60611
Rush Univ. Med. Ctr. ACTG CRSChicago, Illinois  60612
Indiana Univ. School of Medicine, Infectious Disease Research ClinicIndianapolis, Indiana  46202
Johns Hopkins Adult AIDS CRSBaltimore, Maryland  21287
Beth Israel Deaconess - East Campus A0102 CRSBoston, Massachusetts  02215
Beth Israel Deaconess Med. Ctr., ACTG CRSBoston, Massachusetts  02215
Bmc Actg CrsBoston, Massachusetts  02118
Washington U CRSSt. Louis, Missouri  
SUNY - Buffalo, Erie County Medical Ctr.Buffalo, New York  14215
NY Univ. HIV/AIDS CRSNew York, New York  10016
Memorial Sloan-Kettering Cancer Ctr.New York, New York  10021
Beth Israel Med. Ctr. (Mt. Sinai)New York, New York  10003
Univ. of Rochester ACTG CRSRochester, New York  14642
Unc Aids CrsChapel Hill, North Carolina  27599
Case CRSCleveland, Ohio  44106
The Ohio State Univ. AIDS CRSColumbus, Ohio  43210
Hosp. of the Univ. of Pennsylvania CRSPhiladelphia, Pennsylvania  19104
Pitt CRSPittsburgh, Pennsylvania  15213