Trial of Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD) in Patients With Relapsed Non-Hodgkins Lymphoma

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academic and Community Cancer Research United; Mayo Clinic
• Collaborator: Mayo Clinic
• Treatments: BB 1101; Cytarabine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Oxaliplatin; Rituximab

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