Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
Other chemotherapies have been tried in patients with AIDS related lymphomas, but the results have not been satisfactory. This study will show whether the combination of chemotherapy, radiation, and AZT is more effective and less toxic than previously used treatments.
All patients will receive combination chemotherapy and AZT. The combination chemotherapy will be repeated every 3 to 4 weeks for a maximum total of 6 cycles. Each cycle will consist of doxorubicin, bleomycin, cyclophosphamide, and vincristine on day 1, dexamethasone on days 1-5, and methotrexate on day 15. Patients with menin...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Concurrent Medication:
- Allowed:
- • Ibuprofen.
- • Standard antiemetic agents.
- • Ganciclovir therapy for sight- or life-threatening Cytomegalovirus infection.
- • Zidovudine and methotrexate may be resumed during ganciclovir maintenance phase.
- • Exclusion Criteria
- Co-existing Condition:
- The following patients will be excluded from the study:
- • Patients with recurrent infection that may interfere with the planned protocol.
- • Patients with a second active tumor other than nonmelanomatous skin cancer or Kaposi's sarcoma.
- • Patients with stage IE primary central nervous system lymphoma.
- Concurrent Medication:
- Excluded:
- • Corticosteroids.
- • Aspirin.
- • Acetaminophen.
- • Nonsteroidal anti-inflammatory drugs, except ibuprofen.
- • Chemotherapy for infection associated with neutropenia.
- • Zidovudine (AZT) for infection associated with neutropenia.
- • Investigational therapies, except ganciclovir therapy for sight- or life-threatening cytomegalovirus infection.
- • AZT and methotrexate will be suspended during induction therapy with ganciclovir.
- The following patients will be excluded from the study:
- • Patients with recurrent infection that may interfere with the planned protocol.
- • Patients with a second active tumor other than nonmelanomatous skin cancer or Kaposi's sarcoma.
- • Patients with stage IE primary central nervous system lymphoma.
- Prior Medication:
- Excluded:
- • Zidovudine (AZT).
- * Excluded within 2 weeks of study entry:
- • Immunomodulating agents.
- • Antiretroviral therapy prior to diagnosis of lymphoma.
- Patients must demonstrate the following clinical and laboratory findings:
- • Any stage of the disease, including stage I.
- • Newly diagnosed, previously untreated high-grade lymphoma.
- • Presence of measurable tumor parameter(s).
- • Adequate hepatic, renal, and bone marrow function.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
New York, New York, United States
New York, New York, United States
West Columbia, South Carolina, United States
Worcester, Massachusetts, United States
New York, New York, United States
Rochester, New York, United States
Los Angeles, California, United States
San Francisco, California, United States
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
Washington, District Of Columbia, United States
Hershey, Pennsylvania, United States
Patients applied
Trial Officials
Levine A
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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