Trial of Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD) in Patients With Relapsed Non-Hodgkins Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD)
Intervention description: rituximab 375 mg/m2 IV Weekly x 4 1 cycle only
dexamethasone 40 mg PO/IV Days 2-5 q 21 days 2 cycles
oxaliplatin 130 mg/m2 IV Day 2 q 21 days 2 cycles
cytosine arabinoside 2000 mg/m2 x 2 doses IV Days 2-3 q 21 days 2 cycles
pegfilgrastim 6 mg SQ Day 4 q21 days 2 cycles
Intervention MeSH terms: Cytarabine; Dexamethasone; Oxaliplatin; Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: C04.557.386

Summary:

      The goals of this protocol are to determine the effect of oxaliplatin, cytosine arabinoside,
      and dexamethasone with Rituxan (ROAD) as treatment for patients with relapsed CD20+ B-cell
      non-Hodgkins lymphoma (NHL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with any stage (I-IV, including those with bone marrow involvement) relapsed
             CD20+ B-cell non-Hodgkins lymphoma, within 5 years, with aggressive histology who have
             not responded to, or relapsed after, initial chemotherapy and would, if treated
             off-study, be treated with a platinum-containing regimen.

          -  CD20+ diffuse large cell, mantle cell, or transformed histologies are eligible.

          -  Tumor biopsy to demonstrate histology < = 6 weeks prior to registration. Computed
             tomography (CT) or ultrasound guided needle biopsies are acceptable as long as the
             pathologists can confirm histology and the CD20 positivity of the tumor.

          -  Measurable disease (to be considered measurable the lesion must be greater than or
             equal to 1.5 x 1.5 cm).

          -  Greater than or equal to 18 years of age.

          -  ECOG performance status (PS) 0, 1, or 2.

          -  Limited to one prior chemotherapy regimen. Antibody therapy alone or immunotherapy
             alone will not count as a prior regimen - only chemotherapy regimens (for example -
             RCHOP, CVP, etc.). External beam radiation therapy does not count as a regimen.

          -  The following laboratory values obtained less than or equal to 14 days prior to
             registration:

               -  Absolute neutrophil count (ANC) greater than or equal to 1500

               -  Platelets (PLT) greater than or equal to 75,000

               -  Total bilirubin less than or equal to 2 mg/dL

               -  Creatinine less than or equal to 1.5 x upper normal limit (UNL)

        Exclusion Criteria:

          -  Any of the following as this regimen may be harmful to a developing fetus or nursing
             child:

               -  Pregnant women

               -  Nursing women

               -  Women of childbearing potential or their sexual partners who are unwilling to
                  employ adequate contraception (condoms, diaphragm, birth control pills,
                  injections, intrauterine device [IUD], surgical sterilization, subcutaneous
                  implants, or abstinence, etc.)

          -  HIV infection.

          -  Prior chemotherapy or biologic therapy <= 4 weeks prior to registration .

          -  Persistent acute toxicities due to prior chemotherapy or biologic therapy.

          -  Active malignancies other than NHL.

          -  Central nervous system (CNS) lymphoma.

          -  Any of the following comorbid conditions:

               -  Uncontrolled diabetes mellitus

               -  Uncontrolled hypertension

               -  Uncontrolled peptic ulcer disease

               -  Uncontrolled infection