search
Back to results

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

Primary Purpose

Lymphoma, Non-Hodgkin, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bleomycin sulfate
Vincristine sulfate
Doxorubicin hydrochloride
Cyclophosphamide
Allopurinol
Methotrexate
Cytarabine
Leucovorin calcium
Zidovudine
Dexamethasone
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Vincristine, Lymphoma, Methotrexate, Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin, Drug Therapy, Combination, Combined Modality Therapy, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, Combined, Zidovudine, Bleomycin

Eligibility Criteria

19 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Los Angeles County - USC Med Ctr
  • UCLA CARE Ctr
  • San Francisco AIDS Clinic / San Francisco Gen Hosp
  • George Washington Univ Med Ctr
  • Charity Hosp / Tulane Univ Med School
  • Louisiana State Univ Med Ctr / Tulane Med School
  • Tulane Univ School of Medicine
  • Univ of Massachusetts Med Ctr
  • Bellevue Hosp / New York Univ Med Ctr
  • Saint Luke's - Roosevelt Hosp Ctr
  • Mount Sinai Med Ctr
  • Univ of Rochester Medical Center
  • Milton S Hershey Med Ctr
  • Julio Arroyo

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT00000703
Brief Title
Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members
Official Title
Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 1990 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin, HIV Infections
Keywords
Vincristine, Lymphoma, Methotrexate, Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin, Drug Therapy, Combination, Combined Modality Therapy, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, Combined, Zidovudine, Bleomycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
45 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Bleomycin sulfate
Intervention Type
Drug
Intervention Name(s)
Vincristine sulfate
Intervention Type
Drug
Intervention Name(s)
Doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Type
Drug
Intervention Name(s)
Leucovorin calcium
Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Dexamethasone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Levine A
Official's Role
Study Chair
Facility Information:
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA CARE Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
San Francisco AIDS Clinic / San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Charity Hosp / Tulane Univ Med School
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Louisiana State Univ Med Ctr / Tulane Med School
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane Univ School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Univ of Massachusetts Med Ctr
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Saint Luke's - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Univ of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Milton S Hershey Med Ctr
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
170330850
Country
United States
Facility Name
Julio Arroyo
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7690462
Citation
Saag MS, Emini EA, Laskin OL, Douglas J, Lapidus WI, Schleif WA, Whitley RJ, Hildebrand C, Byrnes VW, Kappes JC, et al. A short-term clinical evaluation of L-697,661, a non-nucleoside inhibitor of HIV-1 reverse transcriptase. L-697,661 Working Group. N Engl J Med. 1993 Oct 7;329(15):1065-72. doi: 10.1056/NEJM199310073291502.
Results Reference
background
PubMed Identifier
1710673
Citation
Levine AM, Wernz JC, Kaplan L, Rodman N, Cohen P, Metroka C, Bennett JM, Rarick MU, Walsh C, Kahn J, et al. Low-dose chemotherapy with central nervous system prophylaxis and zidovudine maintenance in AIDS-related lymphoma. A prospective multi-institutional trial. JAMA. 1991 Jul 3;266(1):84-8.
Results Reference
background
Citation
ICDB/89653727. Levine AM, et al. Low dose chemotherapy with CNS prophylaxis and zidovudine (AZT) maintenance for aids-related lymphoma: preliminary results of a multi-institutional study. Proc Annu Meet Am Soc Clin Oncol. 1989 8:A18
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs