Clinical trial NCT00166439: Trial of Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD) in Patients With Relapsed Non-Hodgkins Lymphoma
Official title: A Phase II Trial of Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD) in Patients With Relapsed CD20+ B-Cell Non-Hodgkins Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: C04.557.386
Lead sponsor: Academic and Community Cancer Research United
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2005-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall Response Rate After Two Cycles of ROAD
timeFrame: Up to 42 days
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to 10 years
measure: Progression-free Survival
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Patrick B. Johnston, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: