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

Completed · Phase 2

Conditions studied: Lymphoma

In brief

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).

Key facts

Study ID

NCT00166439

Run by

Academic and Community Cancer Research United

People needed

50

Starts

2005-03-01

Expected to finish

2015-09-01

Last updated by the study team

2020-01-14

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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