The Use of Chemotherapy Plus Radiotherapy Plus Azidothymidine in Patients With AIDS-Related Lymph Node Cancer
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on May 09, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma, Non-Hodgkin; HIV Infections
Intervention: Methotrexate (Drug); Leucovorin calcium (Drug); Zidovudine (Drug); Dexamethasone (Drug)
Phase: N/A
Status: Terminated
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Levine AM, Study Chair
Summary
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.
Clinical Details
Official title:
Chemotherapy, Radiotherapy, and Azidothymidine for AIDS-Related Primary CNS Lymphoma
Study design: Interventional, Treatment
Detailed description:
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
San Francisco AIDS Clinic / San Francisco Gen Hosp, San Francisco, California 941102859, United States
UCLA CARE Ctr, Los Angeles, California 90095, United States
Los Angeles County - USC Med Ctr, Los Angeles, California 90033, 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
Univ of Rochester Medical Center, Rochester, New York 14642, 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
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
Saint Luke's - Roosevelt Hosp Ctr, New York, New York 10025, United States
Julio Arroyo, West Columbia, South Carolina 29169, United States
Additional Information
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Last updated: June 23, 2005
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