Suspended

Prospective Non Randomized Study With Chemotherapy in Patients With Hodgkin's Disease and HIV Infection: "Stanford V Regimen" For "Low Risk" Patients, "EBVP Regimen" For "High Risk" Patients

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What is being tested

bleomycin sulfate

+ filgrastim

+ Stanford V regimen

BiologicalDrug
Who is being recruted

Hemic and Lymphatic Diseases+6

+ Immune System Diseases

+ Immunoproliferative Disorders

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 1997
See protocol details

Summary

Principal SponsorCentro di Riferimento Oncologico - Aviano
Last updated: September 20, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 1997

Actual date on which the first participant was enrolled.

OBJECTIVES: 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.

NCT00003262
Principal SponsorCentro di Riferimento Oncologico - Aviano
Last updated: September 20, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeHodgkin DiseaseLymphoma

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 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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Centro di Riferimento Oncologico - Aviano

Aviano, ItalyOpen Centro di Riferimento Oncologico - Aviano in Google Maps
SuspendedOne Study Center