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Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members Clinical research trials and Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members. Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members clinical trial. Human subjects often obtain the finest healthcare possible for their Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members  Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members
Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members
For Condition: Lymphoma, Non-Hodgkin,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 19 Years/69 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 45
Location and Contact Information:
Overall Study Official:
LevineA, Study Chair,
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Additional Information:
Study ID Numbers: ACTG 008;
Study Start Date:
Record last reviewed: December 1988
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000703
Other Hiv Infections Studies:
1. A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma
2. A Study of Patients with AIDS Syndrome
3. Selective T-Cell Depletion to Reduce Graft-Versus-Host-Disease in Patients Receiving Stem Cell Transplantation to Treat Leukemia, Lymphoma or Myelodysplastic Syndromes
4. Pegfilgrastim PBPC Mobilization Study
5. Randomized double cord blood transplant study
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members
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