Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection
NCT ID: NCT00003262
Last Updated: 2013-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
1997-05-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of two combination chemotherapy regimens in treating patients with Hodgkin's disease and HIV infection.
Detailed Description
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* 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.
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/mm\^3).
* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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bleomycin sulfate
filgrastim
Stanford V regimen
doxorubicin hydrochloride
epirubicin hydrochloride
etoposide
mechlorethamine hydrochloride
prednisone
vinblastine sulfate
vincristine sulfate
Eligibility Criteria
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Inclusion Criteria
* 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
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
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No prior therapy for Hodgkin's disease
* Concurrent triple-drug antiretroviral therapy (including one protease inhibitor) required
18 Years
ALL
No
Sponsors
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Centro di Riferimento Oncologico - Aviano
OTHER
Principal Investigators
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Umberto Tirelli, MD
Role: STUDY_CHAIR
Centro di Riferimento Oncologico - Aviano
Locations
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Centro di Riferimento Oncologico - Aviano
Aviano, , Italy
Countries
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References
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Spina M, Gabarre J, Rossi G, Fasan M, Schiantarelli C, Nigra E, Mena M, Antinori A, Ammassari A, Talamini R, Vaccher E, di Gennaro G, Tirelli U. Stanford V regimen and concomitant HAART in 59 patients with Hodgkin disease and HIV infection. Blood. 2002 Sep 15;100(6):1984-8. doi: 10.1182/blood-2002-03-0989.
Other Identifiers
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ITA-GICAT-POS5
Identifier Type: -
Identifier Source: secondary_id
EU-97022
Identifier Type: -
Identifier Source: secondary_id
CDR0000066154
Identifier Type: -
Identifier Source: org_study_id