A Phase II Trial of Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD) in Patients With Relapsed CD20+ B-Cell Non-Hodgkins Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Phase II Trial of Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD) in Patients With Relapsed CD20+ B-Cell Non-Hodgkins Lymphoma


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The proportion of successes will be estimated by the number of successes divided by the total number.

Outcome Time Frame:

Every 3 weeks

Safety Issue:

Yes

Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

MC0485

NCT ID:

NCT00166439

Start Date:

March 2005

Completion Date:

Related Keywords:

  • Lymphoma
  • C04.557.386
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location
Mayo Clinic Rochester, Minnesota  55905