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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00003262
• Other study ID #: CDR0000066154
• Secondary ID: ITA-GICAT-POS5EU
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: September 19, 2013
• Start date: May 1997

Study information

• Verified date: October 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Hodgkin Disease
• Lymphoma

Intervention

Biological:
• bleomycin sulfate

• filgrastim

Drug:
• Stanford V regimen

• doxorubicin hydrochloride

• epirubicin hydrochloride

• etoposide

• mechlorethamine hydrochloride

• prednisone

• vinblastine sulfate

• vincristine sulfate

Locations

Country	Name	City	State
Italy	Centro di Riferimento Oncologico - Aviano	Aviano

Sponsors (1)

Lead Sponsor	Collaborator
Centro di Riferimento Oncologico - Aviano

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation