Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Phase I Trial of mBACOD and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in AIDS-Associated Large Cell, Immunoblastic, and Small Non-Cleaved Lymphoma
This study has been completed.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000689
  Purpose

To determine the toxicity and effectiveness of adding sargramostim (recombinant granulocyte-macrophage colony stimulating factor; GM-CSF) to a standard chemotherapy drug combination (methotrexate, bleomycin, doxorubicin, cyclophosphamide, vincristine, and dexamethasone) known as mBACOD in the treatment of non-Hodgkin's lymphoma in patients who are infected with HIV.

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.


Condition Intervention Phase
Lymphoma, Non-Hodgkin
HIV Infections
Drug: Bleomycin sulfate
Drug: Vincristine sulfate
Drug: Doxorubicin hydrochloride
Drug: Cyclophosphamide
Drug: Methotrexate
Drug: Cytarabine
Drug: Leucovorin calcium
Drug: Sargramostim
Drug: Dexamethasone
Phase I

MedlinePlus related topics: AIDS Cancer Lymphoma
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Cytarabine Cytarabine hydrochloride Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Methotrexate Vincristine sulfate Vincristine Sargramostim Granulocyte-macrophage colony-stimulating factor Calcium gluconate Bleomycin Bleomycin sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase I Trial of mBACOD and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in AIDS-Associated Large Cell, Immunoblastic, and Small Non-Cleaved Lymphoma

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 18
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000689

Locations
United States, California
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
USC School of Medicine / Norris Cancer Hosp
Los Angeles, California, United States, 90033
United States, New York
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Sponsors and Collaborators
Investigators
Study Chair: Walsh C
Study Chair: Levine AM
  More Information

Publications:
Study ID Numbers: ACTG 074
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00000689  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
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

Study placed in the following topic categories:
Dexamethasone
Sexually Transmitted Diseases, Viral
Immunoproliferative Disorders
Acquired Immunodeficiency Syndrome
Vincristine
Leucovorin
Cyclophosphamide
Bleomycin
Doxorubicin
Immunologic Deficiency Syndromes
Folic Acid
Virus Diseases
Calcium, Dietary
Lymphatic Diseases
HIV Infections
Sexually Transmitted Diseases
Methotrexate
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Retroviridae Infections
Dexamethasone acetate
Cytarabine
Nervous System Neoplasms

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Slow Virus Diseases
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Reproductive Control Agents
Antibiotics, Antineoplastic
Infection
Hormones
Vitamins
Therapeutic Uses
Abortifacient Agents
Micronutrients
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
Vitamin B Complex
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Growth Substances
Mitosis Modulators
Gastrointestinal Agents

ClinicalTrials.gov processed this record on January 15, 2009