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Home > "T" Clinical Trials Conditions > The Use of Chemotherapy Plus Radiotherapy Plus Azidothymidine in Patients with AIDS-Related Lymph Node Cancer  The Use of Chemotherapy Plus Radiotherapy Plus Azidothymidine in Patients with AIDS-Related Lymph Node Cancer
The Use of Chemotherapy Plus Radiotherapy Plus Azidothymidine in Patients with AIDS-Related Lymph Node Cancer
For Condition: Lymphoma, Non-Hodgkin,HIV Infections
Status: Terminated
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine the safety and toxicity of high-dose systemic methotrexate (MTX) and dexamethasone (DEX) combined with zidovudine (AZT) and brain irradiation in patients with AIDS-related primary central nervous system (CNS) lymphoma and to determine response rates and survival of treated patients. Also to determine if the treatment inhibits HIV replication in patients who are HIV culture and/or antigen positive and to assess the incidence of opportunistic infection in these patients Results of radiation given to patients with AIDS-related high-grade CNS lymphoma have been disappointing, with short survival times due to infection complications. However, complete response has been documented after radiation in some patients. High-dose MTX will be used to improve the possibility of a greater antineoplastic response than that obtained by radiation alone. Since the underlying immunodeficiency state is not affected by therapy directed against the lymphoma, patients are still prone to life-threatening opportunistic infections or relapse of lymphomatous disease within the CNS. Accordingly, AZT will also be used in an attempt to alter the overall natural history of the disease.
Details: Results of radiation given to patients with AIDS-related high-grade CNS lymphoma have been disappointing, with short survival times due to infection complications. However, complete response has been documented after radiation in some patients. High-dose MTX will be used to improve the possibility of a greater antineoplastic response than that obtained by radiation alone. Since the underlying immunodeficiency state is not affected by therapy directed against the lymphoma, patients are still prone to life-threatening opportunistic infections or relapse of lymphomatous disease within the CNS. Accordingly, AZT will also be used in an attempt to alter the overall natural history of the disease. Radiation begins on day 1 of therapy. Patients receive dexamethasone orally (PO) or by intravenous injection (IV) on days 1-10. MTX IV over 6 hours weekly for a total of 4 doses starts 1 week after completion of the cranial radiation. Leucovorin (LCV) IV or PO begins 6 hours after MTX has been completed over 6 hours for 8 doses. AZT while awake starts on day 1 of therapy and continues for 52 weeks. Patients are reevaluated with computerized tomography (CT) or magnetic resonance imaging (MRI) scan of the brain at conclusion of radiation therapy and systemic treatment, 6 and 10 weeks respectively. If there is a complete or partial response (CR or PR), patient will remain on study and continue to receive AZT; if stable disease or no response, patient will be taken off study. Reevaluation at 16 weeks from start of study will be done. If CR or PR, the patient will continue AZT for 1 year. If there is no change or progression of disease, or if the patient develops evidence of systemic lymphomatous disease, patient will be taken off study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Patient must have negative titers for toxoplasmosis or other infectious etiology for CNS disease. Prior Medication: Allowed: - Zidovudine may be continued per protocol specifications. Exclusion Criteria - Pathologic diagnosis of lymphoma in central nervous system (CNS) must be confirmed but no previous treatment is allowed. In participating institutions where CNS biopsies cannot be obtained, the patient may be considered eligible if space-occupying lesions have been demonstrated on computerized tomography or magnetic resonance imaging with negative titers for toxoplasmosis or negative response to empiric therapy for intracerebral toxoplasmosis and negative workup for other infectious etiology of CNS disease. Co-existing Condition: Patients with the following are excluded: - Positive titers for toxoplasmosis. Positive titers for other infectious etiology of CNS disease. Acute intercurrent infection. A second active tumor other than nonmelanomatous skin cancer or Kaposi's sarcoma. Lymphomatous meningitis alone without a mass lesion in the brain. Concurrent Medication: Excluded: - Acetaminophen, nonsteroidal anti- inflammatory agents, and corticosteroids other than dexamethasone. Prior Medication: Excluded: - Acetaminophen, nonsteroidal anti-inflammatory agents, and corticosteroids other than dexamethasone. - Excluded within 2 weeks of study entry: - Immunomodulating agents. - Excluded within 30 days of study entry: - Any investigational agent.
Total Enrollment: 45
Location and Contact Information:
Overall Study Official:
LevineAM, Study Chair,
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Additional Information:
Study ID Numbers: ACTG 009;
Study Start Date:
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000723
Other Lymphoma, Non-Hodgkin Studies:
1. The Effects of Combination Anti-HIV Medication on Human Papillomavirus (HPV) in HIV-Infected Women
2. A Study to Test the Effect of Cyclosporine on the Immune System of Patients with Early HIV Disease.
3. A Phase I/II Trial of Ribavirin (With Escalation) + Isoprinosine in Asymptomatic HIV-Viremic Patients
4. HIV Vaccine Designed for HIV Infected Adults Taking Anti-HIV Drugs
5. The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used with and without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
Related Studies:
Other Lymphoma, Non-Hodgkin Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
The Use of Chemotherapy Plus Radiotherapy Plus Azidothymidine in Patients with AIDS-Related Lymph Node Cancer
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