Status:
COMPLETED
Trial of Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD) in Patients With Relapsed Non-Hodgkins Lymphoma
Lead Sponsor:
Academic and Community Cancer Research United
Collaborating Sponsors:
Mayo Clinic
Conditions:
Lymphoma
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief 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 lym...
Detailed Description
Patients with B-cell NHL that comes back after chemotherapy are typically treated with cisplatin, high-dose cytosine arabinoside and dexamethasone (DHAP) or other platinum-based treatments. Recent stu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00166439
Start Date
March 1 2005
End Date
September 1 2015
Last Update
January 14 2020
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905