Clinical trial NCT00003262: Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoma
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-04-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico - Aviano
Study officials:
affiliation: Centro di Riferimento Oncologico - Aviano
name: Umberto Tirelli, MD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1182/blood-2002-03-0989.