Tissue Bank In The Department of Pathology

Ronald Levy, MD

Genes in Predicting Outcome of Patients With Diffuse Large B-Cell Lymphoma Treated With Rituximab and Combination Chemotherapy

Contact Information

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

Primary Contact:

Emily Troutner (650) 725-4968
To view all clinical trials at Stanford, please see the Clinical Trials Directory.

Brief

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients respond to treatment. PURPOSE: This phase II trial is studying how well genes and biomarkers predict outcome of patients with diffuse large B-cell lymphoma treated with rituximab and combination chemotherapy.

Recruiting Status:

Recruiting

Stanford Recruiting Status:

Recruiting

Condition(s):

Intervention(s):

  • Vaccine: rituximab
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: prednisone
  • Drug: vincristine sulfate
  • Gene Transfer: gene expression analysis
  • Gene Transfer: microarray analysis
  • Gene Transfer: polymerase chain reaction
  • Gene Transfer: polymorphism analysis
  • Procedure: immunohistochemistry staining method
  • Procedure: laboratory biomarker analysis

Phase:

Phase 2

Eligibility

Ages Eligible for Study:

18 years to Any Age

Genders Eligible for Study:

Male and Female

Health of Volunteers:

People with the conditions listed in this trial can participate as controls.

Key Inclusion Criteria:

DISEASE CHARACTERISTICS:

- Diagnosis of diffuse large B-cell lymphoma, meeting 1 of the following staging criteria:
o Limited stage I disease that is bulky (i.e., more than 10 cm) or with International Prognostic Index > 1
o Stage II-IV disease

- CD20-positive disease

- Paraffin-embedded tumor specimen must be available

- No active CNS lymphoma

PATIENT CHARACTERISTICS:

- ECOG performance status 0-3

- WBC > 2,500/mm^3

- Absolute neutrophil count > 1,000/mm^3 (unless due to disease in marrow)

- Platelet count > 100,000/mm^3 (unless due to disease in marrow)

- Creatinine < 2.0 mg/dL

- Bilirubin < 1.5 mg/dL (1.5-3.0 mg/dL if due to liver involvement by lymphoma)

- AST and ALT < 3 times upper limit of normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- LVEF > 45%

- No HIV positivity

- No other malignancy except for basal cell carcinoma of the skin or in situ carcinoma of the cervix (unless the tumor was treated with curative intent >= 2 years ago and the patient continues to be free of evidence of recurrence)

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy, radiotherapy, or immunotherapy
o A prior short course (i.e., < 2 weeks) of corticosteroids allowed

Key Exclusion Criteria:

Additional Study Details

Official Title:

Phase II Study to Establish Gene Expression Models Predicting Survival of Diffuse Large B-Cell Lymphoma Patients Treated With R-CHOP

Anticipated start date:

10/5/2008

Lead Sponsor:

Miami University CCC

Study Type:

Interventional

Purpose:

Treatment

Allocation:

Randomized

Masking:

Control:

none

Assignment:

Endpoints:

Unspecified

Primary Outcomes:

  • Biomarkers (immunoglobulin G Fc receptor genotypes, CD20 protein expression, and gene expression profiles)
  • Overall survival at 30 months
  • Overall response
  • Progression-free survival

Secondary Outcomes:

  • Time to treatment failure
  • Response (complete response [CR], CR unconfirmed, partial response)

Total Number to be Enrolled:

213

Total Number to be Enrolled at Stanford:

30

More Information

Trial Unique Id: SU-04022009-2098

Secondary ID(s):

  • 97904
  • LYMNHL0050
  • NCT00450385

Locations & Contacts

Stanford Locations & Contacts:

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

Primary Contact:

Emily Troutner (650) 725-4968

Non-Stanford Locations:

The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.

This listing was last updated:

8/18/2009

PLEASE NOTE:

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.

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