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Phase I Trial of mBACOD and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in AIDS-Associated Large Cell, Immunoblastic, and Small Non-cleaved Lymphoma


Phase 1
13 Years
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin, HIV Infections

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Trial Information

Phase I Trial of mBACOD and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in AIDS-Associated Large Cell, Immunoblastic, and Small Non-cleaved Lymphoma


Treatment of patients with AIDS-associated lymphoma is achieving inferior results when
compared with outcomes for non-AIDS patients. Treatment with mBACOD has been promising, but
the toxicity is very high. Patients treated with mBACOD have very low white blood cell
counts. GM-CSF has increased the number of white blood cells in animal studies and
preliminary human studies. It is hoped that including GM-CSF among the drugs given to
lymphoma patients will prevent or lessen the decrease in white blood cells caused by mBACOD.

Patients admitted to the study receive chemotherapy in 21-day cycles. The length of therapy,
2 - 8 months, depends on how the tumor responds to treatment. Four medicines are given on
day 1 of each cycle by vein (IV) (doxorubicin, cyclophosphamide, bleomycin, vincristine).
Dosages of doxorubicin and cyclophosphamide are increased in later groups of patients if
toxicity in the first group is tolerable. A fifth medicine (dexamethasone) is given by mouth
(PO) on days 1 - 5 of each cycle and the sixth medicine (methotrexate) is given IV on day 15
of each cycle. Leucovorin is given after methotrexate to prevent methotrexate side effects.
GM-CSF treatment is started on day 3 and continued for 11 days. To prevent the spread of the
tumor, a spinal tap is done on 4 occasions to inject cytosine arabinoside directly into the
spinal fluid. If tumor cells are present in the spinal fluid, the patient also takes
cytosine arabinoside by spinal tap 3 x/week until the tumor cells disappear and then at
monthly intervals for 1 year. Patients with tumor cells in the spinal fluid are also given
radiation treatment to the head.

Inclusion Criteria


Inclusion Criteria

Patients must have:

- Positive HIV antibody by ELISA with Western blot confirmation, or positive HIV
culture or serum p24 antigen capture assay, or prior diagnosis of AIDS by the CDC
surveillance criteria.

- Pathological diagnosis of large cell (cleaved or non-cleaved), immunoblastic, or
small non-cleaved lymphoma, stage I, II, III, or IV.

- If displaying systemic ("B") symptoms, evaluation for concurrent opportunistic
infections as follows:

- Buffy coat for Mycobacterium intracellulare-avium (MAI) and cytomegalovirus (CMV)
cultures; serum cryptococcal antigen; some measure of pulmonary function to exclude
Pneumocystis carinii pneumonia including chest x-ray and either gallium scan, blood
gases, or DLCO; stool culture and special stains for Salmonella, Isospora belli,
cryptosporidium, CMV, and MAI in patients with diarrhea; computerized tomography (CT)
scan or magnetic resonance imaging (MRI) of brain, or lumbar puncture for India ink,
acid-fast bacilli smear, cryptococcal antigen, or fungal/mycobacterial culture.

Bone marrow involvement is permitted if the patient meets the hematologic criteria above.

Patients who have central nervous system (CNS) involvement at diagnosis or who are
diagnosed during treatment will receive cranial radiotherapy:

- The total dose of 2400 rads will be delivered at a rate of 200 rads/day to the mid plane
employing parallel opposing, lateral whole brain fields. The lower border of the field
will encompass C2 to cover the meninges.

- Patients will be treated 5 days/week, Monday through Friday, until the total
prescribed dose has been completed.

- Radiation will begin as soon as possible after documentation of lymphomatous disease
in the CNS. If a second course of treatment is required, the 2400 rads is well within
whole brain tolerance for normal tissues (4500-5000 rads).

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

- Acute bacterial or opportunistic infection.

- Second primary cancer other than Kaposi's sarcoma, non-melanoma skin cancer, or
carcinoma in-situ of the cervix.

- Primary central nervous system (CNS) lymphoma.

Concurrent Medication:

Excluded:

- Patients receiving prophylactic or maintenance therapy for bacterial or opportunistic
infections, with the exception of those receiving Fansidar (sulfadoxine /
pyrimethamine) for Pneumocystis carinii pneumonia prophylaxis.

- Antiretroviral agents.

- Immunomodulators.

Patients with the following are excluded:

- Acute bacterial or opportunistic infection.

- Second primary cancer other than Kaposi's sarcoma, non-melanoma skin cancer, or
carcinoma in-situ of the cervix.

- Primary central nervous system (CNS) lymphoma.

Prior Medication:

Excluded:

- Prior therapy for lymphoma.

- Excluded within 1 week of study entry:

- Antiretroviral agents and immunomodulators.

Prior Treatment:

Excluded:

- Prior therapy for lymphoma.

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Walsh C

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 074

NCT ID:

NCT00000689

Start Date:

Completion Date:

March 1991

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • HIV Infections
  • M-BACOD protocol
  • Nervous System Neoplasms
  • Infusions, Intravenous
  • Injections, Intravenous
  • Leucovorin
  • Cytarabine
  • Drug Evaluation
  • Drug Therapy, Combination
  • Granulocyte-Macrophage Colony-Stimulating Factor
  • Administration, Oral
  • Acquired Immunodeficiency Syndrome
  • Antineoplastic Agents, Combined
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

USC CRSLos Angeles, California  90033