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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003262
First received: November 1, 1999
Last updated: September 19, 2013
Last verified: October 2002
  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 2

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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 30
Study Start Date: May 1997
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003262

Locations
Italy
Centro di Riferimento Oncologico - Aviano
Aviano, Italy, 33081
Sponsors and Collaborators
Centro di Riferimento Oncologico - Aviano
Investigators
Study Chair: Umberto Tirelli, MD Centro di Riferimento Oncologico - Aviano
  More Information

Additional Information:
Publications:
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: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 23, 2014