Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000703
First received: November 2, 1999
Last updated: March 28, 2012
Last verified: March 2012

November 2, 1999
March 28, 2012
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Complete list of historical versions of study NCT00000703 on ClinicalTrials.gov Archive Site
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Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members
Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members

To determine the safety and effectiveness of a combination chemotherapy-radiation-zidovudine (AZT) treatment for patients with peripheral lymphoma.

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.

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 meningeal or bone marrow disease will receive radiation and intrathecal cytarabine (ARA-C) while those without will receive ARA-C without radiation. Patients with documented lymphomas in the central nervous system at initial workup will start radiation as soon as possible and intrathecal ARA-C (t.i.w. until cerebrospinal fluid is clear then every month for 1 year); patients with normal lumbar puncture, brain scan, and bone marrow at first diagnosis will begin radiation on day 1 of cycle 3 of chemotherapy. Lumbar punctures for evaluation will be done four times during the first cycle, on days 1, 8, 21, and 28. AZT will be administered every 4 hours, 7 days a week, beginning at the completion of combined chemotherapy, once the patient has achieved a complete remission of the lymphoma, and continuing for 1 year.

Interventional
Not Provided
Primary Purpose: Treatment
  • Lymphoma, Non-Hodgkin
  • HIV Infections
  • Drug: Bleomycin sulfate
  • Drug: Vincristine sulfate
  • Drug: Doxorubicin hydrochloride
  • Drug: Cyclophosphamide
  • Drug: Allopurinol
  • Drug: Methotrexate
  • Drug: Cytarabine
  • Drug: Leucovorin calcium
  • Drug: Zidovudine
  • Drug: Dexamethasone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
March 1990
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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.
Both
19 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000703
ACTG 008, 10984
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Levine A
National Institute of Allergy and Infectious Diseases (NIAID)
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP