Search / Trial NCT00000703

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

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Trial Information

Current as of June 13, 2024

Completed

Keywords

Vincristine Lymphoma Methotrexate Cyclophosphamide Cytarabine Dexamethasone Doxorubicin Drug Therapy, Combination Combined Modality Therapy Acquired Immunodeficiency Syndrome Antineoplastic Agents, Combined Zidovudine Bleomycin

Description

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.

Attachments

readout_NCT00000703_2024-06-13.pdf

4.5 MB

NCT00000703_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

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

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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4 stars
6
3 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

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Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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