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


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Sandhoff Disease


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

This study is no longer recruiting patients.

Sponsored by: Centro di Riferimento Oncologico - Aviano
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
stage II adult Hodgkin's disease
AIDS-related peripheral/systemic lymphoma
stage III adult Hodgkin's disease
stage IV adult Hodgkin's disease
HIV-associated Hodgkin's disease
stage I adult Hodgkin's disease
 Procedure: chemotherapy
 Procedure: biological response modifier therapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Drug: bleomycin
 Drug: doxorubicin
 Drug: epirubicin
 Drug: etoposide
 Drug: filgrastim
 Drug: mechlorethamine
 Drug: prednisone
 Drug: vinblastine
 Drug: vincristine
Phase II

MedlinePlus related topics:  Hodgkin's Disease;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Chemotherapy in Patients with Hodgkin's Disease and HIV Infection: Stanford V Regimen for Low Risk Patients, EBVP Regimen for High Risk Patients

Further Study Details: 

Study start: May 1997

OBJECTIVES: I. 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.

PROTOCOL 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/mm3). 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 above

Criteria

PROTOCOL ENTRY 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

--Prior/Concurrent Therapy--

--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:


Location Information


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

Study chairs or principal investigators

Umberto Tirelli,  Study Chair,  Centro di Riferimento Oncologico - Aviano   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066154; ITA-GICAT-POS5; EU-97022
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003262
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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October 13, 2008



Page Updated: October 3, 2005
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