Molecular Risk Assessment in Planning Treatment for Patients With Non-Hodgkin's Lymphoma
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| ClinicalTrials.gov Identifier: NCT00055640 |
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Recruitment Status :
Completed
First Posted : March 7, 2003
Last Update Posted : June 10, 2010
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Genetic: microarray analysis | Phase 2 |
OBJECTIVES:
- Determine whether molecular risk assessment can identify groups of patients with diffuse large B-cell non-Hodgkin's lymphoma (NHL) who will demonstrate at least 50% difference in early response rates to treatment as determined by positron-emission tomography (PET) imaging.
- Determine, by PET imaging, the response rate of patients treated with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab.
- Determine whether early response rates can be predicted by gene expression profiles at diagnosis in these patients.
- Compare gene expression profiles of patients with refractory or relapsed large cell NHL with profiles of the disease at diagnosis.
- Determine relapse-free and overall survival rates of these patients.
- Determine the feasibility of a new NHL treatment algorithm based on prognostic index and molecular risk, and early response assessment by PET imaging.
OUTLINE: Molecular risk assessment is performed using lymph node tissue from initial diagnosis to test for "activated" genes before starting treatment.
Patients receive rituximab IV over 3-6 hours, cyclophosphamide IV over 30 minutes, doxorubicin IV over 5 minutes, and vincristine IV over 5 minutes on day 1 and oral prednisone on days 1-5. Treatment repeats every 21 days for 3-8 courses. Patients undergo whole-body positron-emission tomography (PET) scanning at baseline and after course 3 to determine response. Results from the genetic testing and PET scans are used to determine further treatment recommendations.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 36-50 patients will be accrued for this study.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 9 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Molecular Risk Guided Treatment Of Diffuse Large B-Cell Non-Hodgkin's Lymphoma |
| Study Start Date : | October 2002 |
| Actual Primary Completion Date : | April 2005 |
| Actual Study Completion Date : | March 2006 |
- Biological: rituximab
Rituximab IV over 3-6 hours.Treatment repeats every 21 days for 3-8 courses.
- Drug: cyclophosphamide
Cyclophosphamide IV over 30 minutes. Treatment repeats every 21 days for 3-8 courses.
- Drug: doxorubicin hydrochloride
Doxorubicin IV over 5 minutes. Treatment repeats every 21 days for 3-8 courses.
- Drug: prednisone
Oral prednisone on days 1-5. Treatment repeats every 21 days for 3-8 courses.
- Drug: vincristine sulfate
Vincristine IV over 5 minutes on day 1. Treatment repeats every 21 days for 3-8 courses.
- Genetic: microarray analysis
genetic testing
- 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. [ Time Frame: Results from the genetic testing and PET scans at baseline and after course 3 to determine response. ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00055640
| United States, Ohio | |
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-7284 | |
| Study Chair: | Omer N. Koc, MD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
| Responsible Party: | Omer N. Koc, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00055640 History of Changes |
| Other Study ID Numbers: |
CWRU1402 P30CA043703 ( U.S. NIH Grant/Contract ) CWRU-060244 CWRU-1402 |
| First Posted: | March 7, 2003 Key Record Dates |
| Last Update Posted: | June 10, 2010 |
| Last Verified: | June 2010 |
Keywords provided by Case Comprehensive Cancer Center:
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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 |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Rituximab Liposomal doxorubicin Doxorubicin Prednisone Vincristine Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents Glucocorticoids Hormones |