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The Use of Chemotherapy Plus Radiotherapy Plus Azidothymidine in Patients With AIDS-Related Lymph Node Cancer

This study has been terminated.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000723
  Purpose

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.


Condition Intervention
Lymphoma, Non-Hodgkin
HIV Infections
Drug: Methotrexate
Drug: Leucovorin calcium
Drug: Zidovudine
Drug: Dexamethasone

MedlinePlus related topics:   AIDS    Cancer    Lymphoma   

Drug Information available for:   Zidovudine    Dexamethasone    Dexamethasone acetate    Dexamethasone Sodium Phosphate    Doxiproct plus    Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Methotrexate    Calcium gluconate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Chemotherapy, Radiotherapy, and Azidothymidine for AIDS-Related Primary CNS Lymphoma

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

Estimated Enrollment:   45

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
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000723

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
Jack Weiler Hosp / Bronx Municipal Hosp    
      Bronx, New York, United States, 10465
Bronx Municipal Hosp Ctr/Jacobi Med Ctr    
      Bronx, New York, United States, 10461
Montefiore Med Ctr / Bronx Municipal Hosp    
      Bronx, New York, United States, 10467
Saint Luke's - Roosevelt Hosp Ctr    
      New York, New York, United States, 10025
United States, South Carolina
Julio Arroyo    
      West Columbia, South Carolina, United States, 29169

Sponsors and Collaborators

Investigators
Study Chair:     Levine AM    
  More Information


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

Study ID Numbers:   ACTG 009
First Received:   November 2, 1999
Last Updated:   July 30, 2008
ClinicalTrials.gov Identifier:   NCT00000723
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
AIDS-Related Opportunistic Infections  
Lymphoma  
Methotrexate  
Leucovorin  
Dexamethasone  
Drug Evaluation  
Drug Therapy, Combination
Combined Modality Therapy
Acquired Immunodeficiency Syndrome
Zidovudine
Brain Neoplasms

Study placed in the following topic categories:
Dexamethasone
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Immunoproliferative Disorders
Acquired Immunodeficiency Syndrome
Zidovudine
Leucovorin
Immunologic Deficiency Syndromes
Central nervous system lymphoma, primary
Folic Acid
Virus Diseases
Lymphatic Diseases
Brain Neoplasms
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Methotrexate
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Retroviridae Infections
Dexamethasone acetate

Additional relevant MeSH terms:
Antimetabolites
Anti-Inflammatory Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Slow Virus Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Reproductive Control Agents
Infection
Hormones
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Vitamins
Abortifacient Agents
Micronutrients
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
Anti-HIV Agents
Neoplasms by Histologic Type
Vitamin B Complex
Immune System Diseases
Antineoplastic Agents, Hormonal
Growth Substances
Gastrointestinal Agents

ClinicalTrials.gov processed this record on December 03, 2008




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