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| Sponsor: | Centro di Riferimento Oncologico - Aviano |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003262 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: bleomycin sulfate Biological: filgrastim Drug: Stanford V regimen Drug: doxorubicin hydrochloride Drug: epirubicin hydrochloride Drug: etoposide Drug: mechlorethamine hydrochloride Drug: prednisone Drug: vinblastine sulfate Drug: vincristine sulfate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | May 1997 |
OBJECTIVES:
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:
High risk patients (those with one or more risk factors) receive the Stanford V regimen, as follows:
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven Hodgkin's disease:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
No concurrent or prior second malignancy except:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| Italy | |
| Centro di Riferimento Oncologico - Aviano | |
| Aviano, Italy, 33081 | |
| Study Chair: | Umberto Tirelli, MD | Centro di Riferimento Oncologico - Aviano |
More Information
| ClinicalTrials.gov Identifier: | NCT00003262 History of Changes |
| Other Study ID Numbers: | CDR0000066154, ITA-GICAT-POS5, EU-97022 |
| Study First Received: | November 1, 1999 |
| Last Updated: | November 2, 2010 |
| Health Authority: | United States: Federal Government |
|
stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma stage III adult Hodgkin lymphoma |
stage IV adult Hodgkin lymphoma AIDS-related peripheral/systemic lymphoma HIV-associated Hodgkin lymphoma |
|
HIV Infections Acquired Immunodeficiency Syndrome Hodgkin Disease Lymphoma Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Bleomycin Doxorubicin Epirubicin Mechlorethamine Etoposide Prednisone Vinblastine Vincristine Lenograstim Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses |