Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection

September 19, 2013 updated by: Centro di Riferimento Oncologico - Aviano

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Aviano, Italy, 33081
        • Centro di Riferimento Oncologico - Aviano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro di Riferimento Oncologico - Aviano

Investigators

  • Study Chair: Umberto Tirelli, MD, Centro di Riferimento Oncologico - Aviano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1997

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

April 22, 2003

First Posted (Estimate)

April 23, 2003

Study Record Updates

Last Update Posted (Estimate)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 19, 2013

Last Verified

October 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066154
  • ITA-GICAT-POS5
  • EU-97022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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