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

Centro di Riferimento Oncologico - Aviano

Status and phase: Unknown; Phase 2

Conditions: Lymphoma

Treatments: Drug: Stanford V regimen; Drug: etoposide; Drug: epirubicin hydrochloride; Drug: prednisone; Drug: doxorubicin hydrochloride; Biological: bleomycin sulfate; Drug: mechlorethamine hydrochloride; Biological: filgrastim; Drug: vincristine sulfate; Drug: vinblastine sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT00003262

CDR0000066154

ITA-GICAT-POS5

EU-97022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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