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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00166439
First received: September 12, 2005
Last updated: April 18, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Lymphoma
Drug: Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • The proportion of successes will be estimated by the number of successes divided by the total number. [ Time Frame: Every 3 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Survival time is defined as the time from registration to death due to any cause [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • The distribution of survival time will be estimated using the method of Kaplan-Meier. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2005
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166439

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

No publications provided

Responsible Party: Patrick B. Johnston, M.D., Ph.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00166439     History of Changes
Other Study ID Numbers: MC0485, MC0485, 2328-04
Study First Received: September 12, 2005
Last Updated: April 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
C04.557.386

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Oxaliplatin
Rituximab
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents

ClinicalTrials.gov processed this record on July 26, 2014