|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| 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 |
| 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 |
| Estimated Enrollment: | 18 |
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 |
Inclusion Criteria
Patients must have:
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.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Contacts and 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 | |
| Study Chair: | Walsh C | |
| Study Chair: | Levine AM |
More Information
| Study ID Numbers: | ACTG 074 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000689 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Dexamethasone Anti-Inflammatory Agents Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Methotrexate Nervous System Neoplasms Immunoproliferative Disorders Antineoplastic Agents, Hormonal Acquired Immunodeficiency Syndrome Vincristine Glucocorticoids Doxorubicin Virus Diseases |
Folic Acid HIV Infections Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic Antimetabolites Sexually Transmitted Diseases, Viral Immunologic Factors Folate Leucovorin Cyclophosphamide Vitamin B9 Anti-Bacterial Agents Vitamins Micronutrients Lymphoma |
|
Anti-Inflammatory Agents Dexamethasone Anti-Infective Agents Slow Virus Diseases Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Therapeutic Uses Abortifacient Agents Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors |
Immunoproliferative Disorders Antineoplastic Agents, Hormonal Immune System Diseases Acquired Immunodeficiency Syndrome Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Doxorubicin Virus Diseases Neoplasms HIV Infections Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic Antimetabolites Sexually Transmitted Diseases, Viral |
