Combination Chemotherapy and Rituximab in Treating Young Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or Acute Lymphoblastic Leukemia

Part of paid clinical trials in Arcadia, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00058461
Phase
PHASE2
Status
Terminated

Conditions

  • B-cell Childhood Acute Lymphoblastic Leukemia
  • Childhood Burkitt Lymphoma
  • Childhood Diffuse Large Cell Lymphoma
  • Childhood Immunoblastic Large Cell Lymphoma
  • L3 Childhood Acute Lymphoblastic Leukemia
  • Recurrent Childhood Acute Lymphoblastic Leukemia
  • Recurrent Childhood Large Cell Lymphoma
  • Recurrent Childhood Lymphoblastic Lymphoma
  • Recurrent Childhood Small Noncleaved Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • ifosfamide — DRUG
    Given IV
  • etoposide — DRUG
    Given IV
  • rituximab — BIOLOGICAL
    Given IV
  • carboplatin — DRUG
    Given IV
  • filgrastim — BIOLOGICAL
    Given SC
  • methotrexate — DRUG
    Given IT
  • cytarabine — DRUG
    Given IT
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

This phase II trial is studying how well rituximab together with ifosfamide, carboplatin, and etoposide works in treating young patients with recurrent or refractory non-Hodgkin's lymphoma or acute lymphoblastic leukemia. Chemotherapy drugs, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining ifosfamide, carboplatin, and etoposide with rituximab may kill more cancer cells.

Key Dates

Start date
Nov 30, 2003
Status verified
Oct 2013
Primary completion
Mar 31, 2007

Study Design

Enrollment
82 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (chemotherapy, rituximab)
    Patients receive ifosfamide IV over 2 hours and etoposide IV over 1 hour on days 3-5, rituximab IV on days 1 and 3, and carboplatin IV over 1 hour on day 3. Patients receive filgrastim (G-CSF) subcutaneously once daily beginning on day 6 and continuing until blood counts recover. Patients also receive intrathecal (IT) chemotherapy comprising methotrexate and cytarabine. Patients with B-cell large cell lymphoma and negative CSF cytology receive IT chemotherapy on day 3 of the first course only. Patients with small non-cleaved cell lymphoma or B-cell acute lymphoblastic leukemia and negative CSF cytology receive IT chemotherapy on day 3. All patients with positive CSF cytology receive IT chemotherapy on days 3, 10, and 17 of the first and second courses. Treatment repeats every 23 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Response rate determined by physical exam and appropriate imaging studies [ Time Frame: Up to 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Oncology GroupArcadiaCalifornia91006-3776-

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By research site
Children's Oncology Group· Arcadia, CA

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