Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed, HIV-Associated Burkitt's Lymphoma

Part of paid clinical trials in La Jolla, California.

Sponsor
AIDS Malignancy Consortium
Study ID
NCT00392834
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • filgrastim — BIOLOGICAL
    given subcutaneously
  • pegfilgrastim — BIOLOGICAL
    given subcutaneously
  • rituximab — BIOLOGICAL
    given IV
  • cyclophosphamide — DRUG
    given IV
  • cytarabine — DRUG
    given intrathecally
  • doxorubicin hydrochloride — DRUG
    given IV
  • etoposide — DRUG
    given IV
  • ifosfamide — DRUG
    given IV
  • leucovorin calcium — DRUG
    given IV
  • liposomal cytarabine — DRUG
    given intrathecally
  • methotrexate — DRUG
    given intrathecally
  • therapeutic hydrocortisone — DRUG
    given intrathecally
  • vincristine sulfate — DRUG
    given IV

Study Details

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. 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. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with newly diagnosed, HIV-associated Burkitt's lymphoma.

Key Dates

Start date
Sep 30, 2006
Status verified
May 2018
Primary completion
Jul 31, 2011
Completion
Jul 31, 2013

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Regimen A (R-CODOX-M chemotherapy)
    Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
  • Experimental: Regimen B (rituximab and IVAC chemotherapy)
    Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.

Primary Outcome Measure

Overall Survival (OS) at 1 Year [ Time Frame: 1 year post treatment ]

Locations (13)

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-
UCSF Medical Center at ParnassusSan FranciscoCalifornia94143-0296-
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21231-2410-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
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-
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbusOhio43210-1240-
Pennsylvania Oncology Hematology Associates, Incorporated - PhiladelphiaPhiladelphiaPennsylvania19106-
Floyd and Delores Jones Cancer Institute at Virginia Mason Medical CenterSeattleWashington98101-
West Virginia University Health Sciences Center - CharlestonCharlestonWest Virginia25304-

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, CAUCSF Medical Center at Parnassus· San Francisco, CASidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MDBeth Israel Deaconess Medical Center· Boston, MA

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