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PROSPECTIVE NON-RANDOMIZED STUDY WITH CHEMOTHERAPY FOR RELAPSED OR REFRACTORY HIV-RELATED NON-HODGKIN'S LYMPHOMA: VMP REGIMEN FOR RELAPSED PATIENTS, CDE REGIMEN FOR REFRACTORY PATIENTS


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

Thank you

Trial Information

PROSPECTIVE NON-RANDOMIZED STUDY WITH CHEMOTHERAPY FOR RELAPSED OR REFRACTORY HIV-RELATED NON-HODGKIN'S LYMPHOMA: VMP REGIMEN FOR RELAPSED PATIENTS, CDE REGIMEN FOR REFRACTORY PATIENTS


OBJECTIVES: I. Evaluate the response rate and duration of response to etoposide,
mitoxantrone, and prednimustine in patients with relapsed HIV-associated non-Hodgkin's
lymphoma (NHL). II. Evaluate the response rate and duration of response to cyclophosphamide,
doxorubicin, and etoposide in patients with refractory HIV-associated NHL. III. Assess the
toxic effects of these regimens in these patients.

OUTLINE: Patients with relapsed non-Hodgkin's lymphoma (NHL) receive oral etoposide and
prednimustine on days 1-5 and intravenous mitoxantrone on day 1 every 3 weeks. Patients with
refractory NHL receive cyclophosphamide, doxorubicin, and etoposide as a continuous infusion
over 4 days every 4 weeks. All patients receive concomitant antiretroviral therapy with
zidovudine or didanosine. G-CSF is given for hematologic support as indicated. All patients
are evaluated for response after 2 courses of chemotherapy. Patients with a complete
response (CR) receive 2 additional courses. Patients with a stable or partial response
receive 2 additional courses and are re-evaluated; those with a CR receive 2 more courses,
while those with a stable or partial response are treated off study at the physician's
discretion. Patients with progressive disease are removed from study.

PROJECTED ACCRUAL: 15-20 patients will be treated on each regimen.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven non-Hodgkin's lymphoma at first
presentation No documented CNS involvement (i.e., primary CNS or meningeal lymphoma)
Positive serologic test for HIV antibodies required No opportunistic infection unless
effectively treated Disease relapsed, refractory, or unresponsive to first-line
chemotherapy No more than 1 prior combination chemotherapy regimen Chemotherapy consisted
of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or a CHOP-like
regimen, ACVBP, or other similar regimen

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: At
least 1 month Hematopoietic: Not specified Hepatic: Bilirubin less than 5 times normal OR
Transaminases less than 5 times normal Renal: Creatinine less than 2 mg/dL

PRIOR CONCURRENT THERAPY: See Disease Characteristics

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:

CDR0000065256

NCT ID:

NCT00002905

Start Date:

June 1995

Completion Date:

Related Keywords:

  • Lymphoma
  • AIDS-related peripheral/systemic lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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