Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed AIDS-Related B-Cell Non-Hodgkin's Lymphoma

Part of paid clinical trials in La Jolla, California.

Sponsor
AIDS Malignancy Consortium
Study ID
NCT00389818
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • filgrastim — BIOLOGICAL
    Supportive therapy: GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.
  • pegfilgrastim — BIOLOGICAL
    GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.
  • rituximab — BIOLOGICAL
    375 mg/m2 IV Day 1 of each cycle
  • sargramostim — BIOLOGICAL
    GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.
  • cyclophosphamide — DRUG
    750 mg/m2 IV Day 1 of each cycle
  • pegylated liposomal doxorubicin hydrochloride — DRUG
    40 mg/m2 IV Day 1 of each cycle
  • prednisone — DRUG
    100 mg PO Days 1-5 of each cycle
  • vincristine sulfate — DRUG
    1.4 mg/m2 IV Day 1 (2.0 mg maximum) of each cycle
  • immunohistochemistry staining method — OTHER
    tissue specimen collected at baseline
  • laboratory biomarker analysis — OTHER
    tissue specimen collected at baseline

Study Details

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving combination chemotherapy together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with newly diagnosed AIDS-related B-cell non-Hodgkin's lymphoma.

Key Dates

Start date
Jan 31, 2007
Status verified
May 2018
Primary completion
Sep 30, 2011
Completion
Sep 30, 2011

Study Design

Enrollment
43 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DR-COP
    Single arm interventional study: all subjects receive DR-COP regimen.

Primary Outcome Measure

Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI . [ Time Frame: After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation ]

Locations (14)

FacilityCityStateZIPSite coordinators
Rebecca and John Moores UCSD Cancer CenterLa JollaCalifornia92093-0658-
UCLA Clinical AIDS Research and Education (CARE) CenterLos AngelesCalifornia90095-1793-
USC/Norris Comprehensive Cancer Center and HospitalLos AngelesCalifornia90089-9181-
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiamiFlorida33136-
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicagoIllinois60611-3013-
Ochsner Cancer Institute at Ochsner Clinic FoundationNew OrleansLouisiana70121-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Boston University Cancer Research CenterBostonMassachusetts02118-
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt LouisMissouri63110-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Albert Einstein Cancer Center at Albert Einstein College of MedicineThe BronxNew York10461-
Case Comprehensive Cancer CenterClevelandOhio44106-5065-
Joan Karnell Cancer Center at Pennsylvania HospitalPhiladelphiaPennsylvania19106-
Virginia Mason Medical CenterSeattleWashington98101-

Find similar trials in La Jolla, CA

By research site
Rebecca and John Moores UCSD Cancer Center· La Jolla, CAUCLA Clinical AIDS Research and Education (CARE) Center· Los Angeles, CAUSC/Norris Comprehensive Cancer Center and Hospital· Los Angeles, CAUniversity of Miami Sylvester Comprehensive Cancer Center - Miami· Miami, FLRobert H. Lurie Comprehensive Cancer Center at Northwestern University· Chicago, ILOchsner Cancer Institute at Ochsner Clinic Foundation· New Orleans, LA

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