|
Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection 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 Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection Clinical research trials and Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection 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 Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection. Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection 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 Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection clinical trial. Human subjects often obtain the finest healthcare possible for their Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection 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.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection  Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection
Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection
For Condition: AIDS-related peripheral/systemic lymphoma,stage 3 adult Hodgkin's disease,stage 4 adult Hodgkin's disease,HIV-associated Hodgkin's disease,stage 2 adult Hodgkin's disease,stage 1 adult Hodgkin's disease
Status: No longer recruiting
Sponsor(s): Centro di Riferimento Oncologico - Aviano ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of two combination chemotherapy regimens in treating patients with Hodgkin's disease and HIV infection.
Details: OBJECTIVES: I. Investigate the effects on survival, life expectancy and quality, toxicity, and immunological status in low risk patients with Hodgkin's Disease and HIV infection treated with the Stanford V regimen and in high risk patients treated with epirubicin, bleomycin, vinblastine, and prednisone. PROTOCOL OUTLINE: Patients are stratified into 2 groups designated as low and high risk on the basis of ECOG performance status (0-2 vs 3-4), presence or absence of AIDS before the diagnosis of Hodgkin's Disease, and immune status (CD4+ cell count greater vs no greater than 100/mm3). Low risk patients (those with no risk factors) receive the EBVP regimen, as follows: Epirubicin intravenously on day 1 Bleomycin intramuscularly or intravenously on day 1 Vinblastine intravenously on day 1 Prednisone orally on days 1-5 Patients also receive daily injections of filgrastim (granulocyte colony-stimulating factor; G-CSF) on days 6-15. This schedule is repeated every 3 weeks for 6 courses. High risk patients (those with one or more risk factors) receive the Stanford V regimen, as follows: Doxorubicin and vinblastine intravenously on days 1 and 15 Mechlorethamine intravenously on day 1 Vincristine and bleomycin intravenously on days 8 and 22 Etoposide intravenously on days 15 and 16 Prednisone orally daily Patients also receive daily injections of G-CSF on days 3-7, 9-13, 17-21, and 23-26. This schedule is repeated every 28 days for 3 courses. Patients are followed every 2 months the first year and then every 3 months thereafter. PROJECTED ACCRUAL: 20-30 patients will initially be accrued in this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically proven Hodgkin's disease: - Clinical or pathologic stage II - IV - Stage I with bulky disease (tumor size greater than 10 cm) and B symptoms Confirmed HIV infection --Prior/Concurrent Therapy-- - No prior therapy for Hodgkin's disease - Concurrent triple-drug antiretroviral therapy (including one protease inhibitor) required --Patient Characteristics-- Age: 18 and over Performance status: WHO 0-4 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No severe cardiac disease Pulmonary: No severe pulmonary disease Other: - No severe neurologic or metabolic disease - No concurrent or prior second malignancy except: *Nonmelanomatous skin cancer *In situ cancer of the cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
UmbertoTirelli, Study Chair, Centro di Riferimento Oncologico - Aviano
Centro di Riferimento Oncologico - Aviano
Aviano, , 33081
Italy
Additional Information:
Study ID Numbers: CDR0000066154; ITA-GICAT-POS5,EU-97022
Study Start Date: May 1997
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003262
Other Aids-Related Peripheral/systemic Lymphoma Studies:
1. Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection
2. Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Disease
Related Studies:
Other AIDS-related peripheral/systemic lymphoma Clinical Trials
Other Clinical Trials
Other Aviano Clinical Trials
Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection
|
|
|
|
|
|
|
|
