Molecular Risk Assessment in Planning Treatment for Patients With Non-Hodgkin's Lymphoma

NCT00055640 | Completed Phase 2 DMC

• 4 other identifiers: CWRU1402P30CA043703CWRU-060244CWRU-1402
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Analyzing genes that are present in cancer cells may be useful as a method for predicting the response of non-Hodgkin's lymphoma to cancer treatment. Imaging procedures such as positron emission tomography (PET) scans may improve the ability to measure how well cancer has responded to treatment. PURPOSE: This phase II trial is studying molecular risk assessment to see how well it works in predicting response to therapy in patients who are receiving treatment for non-Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

stage I adult diffuse large cell lymphoma; contiguous stage II adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Molecular risk assessment to see how well it works in predicting response to therapy in patients who are receiving treatment for non-Hodgkin's lymphoma.

  Results from the genetic testing and PET scans at baseline and after course 3 to determine response.

Interventions

rituximab BIOLOGICAL

Rituximab IV over 3-6 hours.Treatment repeats every 21 days for 3-8 courses.

cyclophosphamide DRUG

Cyclophosphamide IV over 30 minutes. Treatment repeats every 21 days for 3-8 courses.

doxorubicin hydrochloride DRUG

Doxorubicin IV over 5 minutes. Treatment repeats every 21 days for 3-8 courses.

prednisone DRUG

Oral prednisone on days 1-5. Treatment repeats every 21 days for 3-8 courses.

vincristine sulfate DRUG

Vincristine IV over 5 minutes on day 1. Treatment repeats every 21 days for 3-8 courses.

microarray analysis GENETIC

genetic testing

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma * CD20 and/or CD19 positive by immunohistochemistry or flow cytometry * Disease evaluable by positron-emission tomography scan * Diagnostic tissue (either frozen or fresh unfixed) available for molecular testing or willing to undergo a repeat procedure to obtain such tissue * No CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin no greater than 3 mg/dL Renal * Creatinine no greater than 3 mg/dL Cardiovascular * LVEF at least 40% Other * Not pregnant or nursing * Fertile patients must use effective contraception * No significant organ dysfunction that would preclude study chemotherapy * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy * No prior biological response modifier therapy Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy * No prior radioimmunotherapy Surgery * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-7284, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; Prednisone; Vincristine; Microarray Analysis

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Microchip Analytical Procedures; Investigative Techniques

Study Officials

• Omer N. Koc, MD

  Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 6, 2003
• First Posted: March 7, 2003
• Study Start: October 1, 2002
• Primary Completion: April 1, 2005
• Study Completion: March 1, 2006
• Last Updated: June 10, 2010

Record last verified: 2010-06

Locations

US (1)