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
  Purpose

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.


Condition Intervention
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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members

Resource links provided by NLM:


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

Estimated Enrollment: 45
Study Completion Date: March 1990
Detailed 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 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.

  Eligibility

Ages Eligible for Study:   19 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000703

Locations
United States, California
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
United States, Louisiana
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, United States, 70112
Tulane Univ School of Medicine
New Orleans, Louisiana, United States, 70112
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, United States, 01655
United States, New York
Mount Sinai Med Ctr
New York, New York, United States, 10029
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10025
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Pennsylvania
Milton S Hershey Med Ctr
Hershey, Pennsylvania, United States, 170330850
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Sponsors and Collaborators
Investigators
Study Chair: Levine A
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000703     History of Changes
Other Study ID Numbers: ACTG 008, 10984
Study First Received: November 2, 1999
Last Updated: March 28, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vincristine
Lymphoma
Methotrexate
Cyclophosphamide
Cytarabine
Dexamethasone
Doxorubicin
Drug Therapy, Combination
Combined Modality Therapy
Acquired Immunodeficiency Syndrome
Antineoplastic Agents, Combined
Zidovudine
Bleomycin

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunologic Deficiency Syndromes
Immunoproliferative Disorders
Lentivirus Infections
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
BB 1101
Bleomycin
Cyclophosphamide
Cytarabine
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Doxorubicin
Levoleucovorin
Liposomal doxorubicin
Methotrexate
Vincristine

ClinicalTrials.gov processed this record on October 29, 2014