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

NCT00166439 | Completed Phase 2 Results DMC

• 2 other identifiers: MC04852328-04
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Lymphoma

Keywords

C04.557.386

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate After Two Cycles of ROAD

  The overall response rate is defined as the percentage of patients who achieve a response after two cycles of oxaliplatin with rituximab, cytarabine, and dexamethasone (ROAD). A response was considered a Complete Response (CR) or Partial Response (PR) as defined by the NCI Sponsored International Working Group (IWG). CR: Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities PR: ≥ 50% decrease in SPD of the six largest dominant nodes or nodal masses.

  Up to 42 days

Secondary Outcomes (2)

• Overall Survival

  Up to 10 years

• Progression-free Survival

  Up to 10 years

Study Arms (1)

Treatment (ROAD)

EXPERIMENTAL

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.

Drug: Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD)

Interventions

Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD) 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

Treatment (ROAD)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Academic and Community Cancer Research United: lead
• Mayo Clinic: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Lymphoma

Interventions

Oxaliplatin; Cytarabine; Dexamethasone; Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Patrick B. Johnston, M.D., Ph.D.
• Organization: Mayo Clinic

johnston.patrick@mayo.edu

507/284-5362

Study Officials

• Patrick B. Johnston, M.D., Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: March 1, 2005
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 14, 2020
• Results First Posted: January 14, 2020

Record last verified: 2015-10

Locations

US (1)