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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: November 2, 2010
Last verified: October 2002
History of Changes

November 1, 1999
November 2, 2010
May 1997
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Complete list of historical versions of study NCT00003262 on ClinicalTrials.gov Archive Site
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Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection
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.

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.
Interventional
Phase 2
Primary Purpose: Treatment
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
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
Not Provided
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00003262
CDR0000066154, ITA-GICAT-POS5, EU-97022
Not Provided
Not Provided
Centro di Riferimento Oncologico - Aviano
Not Provided
Study Chair: Umberto Tirelli, MD Centro di Riferimento Oncologico - Aviano
National Cancer Institute (NCI)
October 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP