Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed over 15 ITA-GICAT-C/890301 EU-96054

Objectives

I.  Evaluate the remission rate, toxicity, disease-free survival, and overall 
survival associated with epirubicin/bleomycin/vinblastine/prednisone in 
patients with HIV-associated Hodgkin's disease.

II.  Determine whether infectious complications can be decreased in these 
patients by using either zidovudine or didanosine in combination with 
chemotherapy.

III.  Determine whether the use of granulocyte colony-stimulating factor can 
reduce or eliminate chemotherapy treatment delays.

Entry Criteria

Disease Characteristics:

Histologically proven Hodgkin's disease in association with AIDS

Clinical or pathologic stage II/III/IV disease or stage I disease with adverse
prognostic factors, i.e.:
  Bulky disease (tumor mass larger than 10 cm)
  B symptoms

Presence of HIV antibodies determined by ELISA and confirmed by Western blot

Prior/Concurrent Therapy:

No prior therapy

Patient Characteristics:

Age:
  Over 15

Performance status:
  WHO 0-3

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified

Other:
  No severe cardiac, pulmonary, neurologic, or metabolic disease that
     decreases normal life expectancy or contraindicates therapy
  No prior or concurrent malignancy except:
     Nonmelanomatous skin cancer
     In situ cervical carcinoma

Expected Enrollment

It is anticipated that 30-40 patients will be entered.

Outline

All patients receive intravenous epirubicin, bleomycin, and vinblastine on day 
1 and oral prednisone on days 1-5.  Subcutaneous G-CSF is given on days 6-20.  
Treatment repeats every 3 weeks for a total of 6 courses.  Antiretroviral 
therapy with zidovudine or didanosine is given twice daily concomitantly with 
chemotherapy regardless of the CD4 cell count.

Patients are followed every 2 months for 1 year, then every 3 months.

Trial Contact Information

Trial Lead Organizations

Centro di Riferimento Oncologico - Aviano

Umberto Tirelli, MD, Protocol chair		Ph: 39-043-465-9284 Email: utirelli@cro.it