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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00166439
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : March 22, 2017
Information provided by (Responsible Party):
Mayo Clinic

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).

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD) in Patients With Relapsed CD20+ B-Cell Non-Hodgkins Lymphoma
Actual Study Start Date : March 2005
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Intervention Details:
  • Drug: 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

Primary Outcome Measures :
  1. The proportion of successes will be estimated by the number of successes divided by the total number. [ Time Frame: Every 3 weeks ]

Secondary Outcome Measures :
  1. Survival time is defined as the time from registration to death due to any cause [ Time Frame: Duration of study ]
  2. The distribution of survival time will be estimated using the method of Kaplan-Meier. [ Time Frame: End of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00166439

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Patrick B. Johnston, M.D., Ph.D. Mayo Clinic

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Responsible Party: Mayo Clinic Identifier: NCT00166439     History of Changes
Other Study ID Numbers: MC0485
MC0485 ( Other Identifier: Mayo Clinic Cancer Center )
2328-04 ( Other Identifier: Mayo Clinic IRB )
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: October 2015
Keywords provided by Mayo Clinic:
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immunologic Factors