Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003262
Recruitment Status : Unknown
Verified October 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : April 23, 2003
Last Update Posted : September 20, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE April 23, 2003
Last Update Posted Date September 20, 2013
Study Start Date  ICMJE May 1997
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00003262 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection
Official Title  ICMJE 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
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE Not Provided
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February¬†8,¬†2007)
30
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003262
Other Study ID Numbers  ICMJE CDR0000066154
ITA-GICAT-POS5
EU-97022
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Centro di Riferimento Oncologico - Aviano
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Umberto Tirelli, MD Centro di Riferimento Oncologico - Aviano
PRS Account National Cancer Institute (NCI)
Verification Date October 2002

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