DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma, Non-Hodgkin; HIV Infections

Intervention: Bleomycin sulfate (Drug); Vincristine sulfate (Drug); Doxorubicin hydrochloride (Drug); Cyclophosphamide (Drug); Allopurinol (Drug); Methotrexate (Drug); Cytarabine (Drug); Leucovorin calcium (Drug); Zidovudine (Drug); Dexamethasone (Drug)

Phase: N/A

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Levine A, Study Chair

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.

Clinical Details

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

Study design: Primary Purpose: Treatment

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

Minimum age: 19 Years. Maximum age: 69 Years. Gender(s): Both.

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.

Locations and Contacts

Los Angeles County - USC Med Ctr, Los Angeles, California 90033, United States

UCLA CARE Ctr, Los Angeles, California 90095, United States

San Francisco AIDS Clinic / San Francisco Gen Hosp, San Francisco, California 941102859, United States

George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States

Charity Hosp / Tulane Univ Med School, New Orleans, Louisiana 70112, United States

Louisiana State Univ Med Ctr / Tulane Med School, New Orleans, Louisiana 70112, United States

Tulane Univ School of Medicine, New Orleans, Louisiana 70112, United States

Univ of Massachusetts Med Ctr, Worcester, Massachusetts 01655, United States

Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States

Mount Sinai Med Ctr, New York, New York 10029, United States

Saint Luke's - Roosevelt Hosp Ctr, New York, New York 10025, United States

Univ of Rochester Medical Center, Rochester, New York 14642, United States

Milton S Hershey Med Ctr, Hershey, Pennsylvania 170330850, United States

Julio Arroyo, West Columbia, South Carolina 29169, United States

Additional Information

Click here for more information about Zidovudine

Related 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


Last updated: March 28, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017