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

NCT ID: NCT00166439

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2015-09-30

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 lymphoma (NHL).

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 studies have shown a 37% response rate in patients with large cell lymphoma to immunotherapy with Rituxan. Patients <75 years old and in otherwise good health may be candidates for high dose therapy with stem cell rescue if they have disease that remains sensitive to chemotherapy. Typically, patients are administered 2 cycles of DHAP or ICE (ifosfamide, carboplatin, and etoposide) and, if the disease responds, they proceed to high-dose therapy with stem cell support. Even patients not considered transplant candidates are also often treated with DHAP or ICE or other salvage regimens. It is likely that the response rate with DHAP alone in patients eligible for transplant is <59%. Recent studies have attempted to improve on the results from DHAP or ICE by combining them with rituxan. NCCTG has just completed a phase II trial of R-DHAP. Preliminary results of the R-ICE protocol indicate a higher response rate and longer time to progression than traditional ICE.

The problem with DHAP and ICE is that they are associated with significant side effects and specifically, with DHAP the cisplatin often causes kidney problems. In fact, some patients who are considered transplant eligible before DHAP may become transplant ineligible simply by the kidney side effects. Clearly, there is a need to improve the quality of life of patients undergoing treatment and to avoid the kidney problems.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (ROAD)

The treatment regimen included oxaliplatin with rituximab, cytarabine, and dexamethasone (ROAD); specifically, rituximab 375 mg/m\^2 IV on days 1, 8,15, and 22 (cycle 1 only); dexamethasone 40 mg PO/IV days 2-5; oxaliplatin 130 mg/m\^2 IV over 2 hours on day 2; cytarabine 2000 mg/m\^2 IV in 250 mL of D5W over three hours x two doses on days 2-3. The second dose of cytarabine was to be given no sooner than 12 hours after the first dose and no later than 24 hours after the conclusion of the first dose. This permitted outpatient administration if desired. Patients were provided pegfilgrastim 6 mg SC on day 4. A cycle was 21 days.

Group Type: EXPERIMENTAL

Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD)

Intervention Type: DRUG

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

Interventions

Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD)

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 Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Academic and Community Cancer Research United

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick B. Johnston, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

MC0485

Identifier Type: OTHER

Identifier Source: secondary_id

2328-04

Identifier Type: OTHER

Identifier Source: secondary_id

MC0485

Identifier Type: -

Identifier Source: org_study_id