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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Umberto Tirelli, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centro di Riferimento Oncologico - Aviano

Authority:

United States: Federal Government

Study ID:

CDR0000066154

NCT ID:

NCT00003262

Start Date:

May 1997

Completion Date:

Related Keywords:

  • Lymphoma
  • stage I adult Hodgkin lymphoma
  • stage II adult Hodgkin lymphoma
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • AIDS-related peripheral/systemic lymphoma
  • HIV-associated Hodgkin lymphoma
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Hodgkin Disease
  • Lymphoma

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