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 94305Brief
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:
RecruitingStanford Recruiting Status:
RecruitingCondition(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 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth 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-CHOPAnticipated start date:
10/5/2008Lead Sponsor:
Miami University CCCInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Control:
noneAssignment:
Endpoints:
UnspecifiedPrimary 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:
213Total Number to be Enrolled at Stanford:
30More Information
Secondary ID(s):
- 97904
- LYMNHL0050
- NCT00450385
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-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:
8/18/2009PLEASE 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.

