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

NCT00000703 | Completed

• 2 other identifiers: ACTG 00810984
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 14

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.

Conditions

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

Interventions

Bleomycin sulfate DRUG

Vincristine sulfate DRUG

Doxorubicin hydrochloride DRUG

Cyclophosphamide DRUG

Allopurinol DRUG

Methotrexate DRUG

Cytarabine DRUG

Leucovorin calcium DRUG

Zidovudine DRUG

Dexamethasone DRUG

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (14)

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Location

UCLA CARE Ctr

Los Angeles, California, 90095, United States

Location

San Francisco AIDS Clinic / San Francisco Gen Hosp

San Francisco, California, 941102859, United States

Location

George Washington Univ Med Ctr

Washington D.C., District of Columbia, 20037, United States

Location

Charity Hosp / Tulane Univ Med School

New Orleans, Louisiana, 70112, United States

Location

Louisiana State Univ Med Ctr / Tulane Med School

New Orleans, Louisiana, 70112, United States

Location

Tulane Univ School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Univ of Massachusetts Med Ctr

Worcester, Massachusetts, 01655, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

Saint Luke's - Roosevelt Hosp Ctr

New York, New York, 10025, United States

Location

Mount Sinai Med Ctr

New York, New York, 10029, United States

Location

Univ of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Milton S Hershey Med Ctr

Hershey, Pennsylvania, 170330850, United States

Location

Julio Arroyo

West Columbia, South Carolina, 29169, United States

Location

Related Publications (3)

• 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.

  PMID: 7690462 BACKGROUND

• 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.

  PMID: 1710673 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; HIV Infections; Lymphoma; Acquired Immunodeficiency Syndrome

Interventions

Bleomycin; Vincristine; Doxorubicin; Cyclophosphamide; Allopurinol; Methotrexate; Cytarabine; Leucovorin; Zidovudine; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Purines; Aminopterin; Pterins; Pteridines; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Coenzymes; Enzymes and Coenzymes; Thymidine; Dideoxynucleosides; Deoxyribonucleosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Officials

• Levine A

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: March 1, 1990
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

US (14)