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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 Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on 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 conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. 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 Clinical research trials and 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 healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including 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. 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 Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a 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 clinical trial. Participants typically obtain the most effective healthcare available for their 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 condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: Lymphoma, Non-Hodgkin,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Schering-Plough
Synopsis: To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.
Details: HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy. Patients are randomized to one of two treatment groups. Patients are stratified for (1) presence or absence of a prior AIDS diagnosis, (2) Karnofsky performance status of 70 or greater and lower than 70. Treatment includes prophylaxis for meningeal lymphoma and Pneumocystis carinii pneumonia. Patients on low-dose mBACOD who experience neutropenia may be given rGM-CSF until the absolute neutrophil count improves. AZT may be initiated at the completion of chemotherapy for all patients in complete remission at that time. PER AMENDMENT 5/30/95: This trial was closed to accrual on 11/7/94 on the recommendation of the Data and Safety Monitoring Board (DSMB), because the non-significant difference in survival between the 2 treatment groups was not expected to change with further enrollment.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - PCP prophylaxis with Bactrim, aerosolized pentamidine, or dapsone. Allowed: ddI, except when patient is also taking allopurinol. Patients must have the following: - Diagnosis of HIV seropositivity and non-Hodgkin's lymphoma. - Ability to give informed consent and willingness to comply with all procedures and visit schedule. - If between ages of 12 and 18 must receive care under direct supervision of a pediatric oncologist, and have consent of parent, guardian, or person with power of attorney. - Participation in clinical trials of other antiretroviral agents is at the discretion of the investigator and individual patient. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Active opportunistic infection, excluding Mycobacterium avium complex, requiring antibiotic therapy. - Another prior or current malignancy, excepting curatively treated cervical or basal cell carcinoma. - Kaposi's sarcoma if rapidly progressive, with visceral involvement, or causing peripheral edema. - Primary central nervous system lymphoma. Concurrent Medication: Excluded: - Zidovudine (AZT) or any antiretroviral agent unless allowed by investigator. ddI is allowed except when also taking allopurinol. Systemic myelosuppressive drugs, including trimethoprim/sulfamethoxazole (T/S), pyrimethamine/sulfa, or ganciclovir. Patients with the following are excluded: - Active opportunistic infection, excluding Mycobacterium avium complex, requiring antibiotic therapy. - Another prior or current malignancy, excepting curatively treated cervical or basal cell carcinoma. - Kaposi's sarcoma if rapidly progressive, with visceral involvement, or causing peripheral edema. - Primary central nervous system lymphoma. Prior Medication: Excluded: - Immunomodulating agents within 2 weeks of study entry. Prior Treatment: Excluded: - Chemotherapy. Radiation therapy as outlined in protocol.
Total Enrollment: 250
Location and Contact Information:
Overall Study Official:
LKaplan, Study Chair,
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Columbia Presbyterian Med Ctr
New York City, New York, 100323784
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
K Norris Cancer Hosp / Los Angeles County - USC Med Ctr
Los Angeles, California, 900331079
United States
Univ of Pittsburgh Med School / Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Univ Hosp / Univ of Colorado Health Sci Ctr
Denver, Colorado, 80262
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania,
United States
Huntington Memorial Hosp / Children's Hosp of Los Angeles
Pasadena, California, 91105
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Denver Dept of Health and Hosps
Denver, Colorado, 80262
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Olive View Med Ctr
Sylmar, California, 91342
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Hemophilia Ctr of Western PA / Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15219
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Additional Information:
Study ID Numbers: ACTG 142;
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000658
Other Lymphoma, Non-Hodgkin Studies:
1. Proleukin in combination with Rituxan in patients with intermediate and high-grade Non-Hodgkin's lymphoma.
2. The Use of Chemotherapy Plus Radiotherapy Plus Azidothymidine in Patients with AIDS-Related Lymph Node Cancer
3. A Study of Mitoguazone Dihydrochloride in Patients with AIDS-Related Non-Hodgkin's Lymphoma
4. A Study of Azidothymidine (AZT) in the Treatment of HIV Infection in Patients Receiving a Bone Marrow Transplant
5. Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members
Related Studies:
Other Lymphoma, Non-Hodgkin Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
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
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