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

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000703

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

MedlinePlus related topics: AIDS Lymphoma

Drug Information available for: Zidovudine Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Cytarabine Cytarabine hydrochloride Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Methotrexate Vincristine sulfate Vincristine Calcium gluconate Bleomycin Allopurinol Allopurinol sodium Bleomycin sulfate

U.S. FDA Resources

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

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

Estimated Enrollment:

45

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

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

Locations

United States, California
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
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
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, United States, 70112
Tulane Univ School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, United States, 01655
United States, New York
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Mount Sinai Med Ctr
New York, New York, United States, 10029
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10025
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

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:

Levine A

More Information

Click here for more information about Zidovudine This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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

Study ID Numbers:	ACTG 008
Study First Received:	November 2, 1999
Last Updated:	July 11, 2008
ClinicalTrials.gov Identifier:	NCT00000703
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

Study placed in the following topic categories:

Dexamethasone
Sexually Transmitted Diseases, Viral
Allopurinol
Leucovorin
Zidovudine
Cyclophosphamide
Methotrexate
Retroviridae Infections
Lymphoma
Cytarabine
Dexamethasone acetate
Immunoproliferative Disorders
Acquired Immunodeficiency Syndrome

Vincristine
Bleomycin
Immunologic Deficiency Syndromes
Doxorubicin
Virus Diseases
Folic Acid
Lymphatic Diseases
Calcium, Dietary
HIV Infections
Sexually Transmitted Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Slow Virus Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Therapeutic Uses
Free Radical Scavengers
Abortifacient Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Anti-HIV Agents

Immune System Diseases
Antineoplastic Agents, Hormonal
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Neoplasms
Antineoplastic Agents, Phytogenic
Antimetabolites
Antioxidants
Immunologic Factors
Antineoplastic Agents
Reproductive Control Agents
Antibiotics, Antineoplastic
Infection
Gout Suppressants
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009