LymphomaPhase 2NCT00055640
Molecular Risk Assessment in Planning Treatment for Patients With Non-Hodgkin's Lymphoma
A Phase 2 study testing rituximab, cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- rituximab, cyclophosphamide and doxorubicin hydrochloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Mar 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-7284
About this study
Official title: Molecular Risk Guided Treatment Of Diffuse Large B-Cell Non-Hodgkin's Lymphoma
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.
Read the detailed description
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.
- Conditions
- Lymphoma
- Being tested
- rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, vincristine sulfate
- 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
- Medical subject headings
- Lymphoma, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
Rituximab IV over 3-6 hours.Treatment repeats every 21 days for 3-8 courses.
cyclophosphamideDrug
Cyclophosphamide IV over 30 minutes. Treatment repeats every 21 days for 3-8 courses.
Doxorubicin IV over 5 minutes. Treatment repeats every 21 days for 3-8 courses.
prednisoneDrug
Oral prednisone on days 1-5. Treatment repeats every 21 days for 3-8 courses.
Vincristine IV over 5 minutes on day 1. Treatment repeats every 21 days for 3-8 courses.
microarray analysisGenetic
genetic testing
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Results from the genetic testing and PET scans at baseline and after course 3 to determine response.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2003 (estimated)
- Study startOct 2002
- Primary completionApr 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Omer N. Koc, MD, Study chair, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055640
- Sponsor's protocol ID
- CWRU1402
- Other IDs
- P30CA043703, CWRU-060244, CWRU-1402
- Status last verified
- Jun 2010
- First submitted
- 6 Mar 2003
- Last updated
- 10 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Risk Guided Treatment Of Diffuse Large B-Cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00055640
- Acronym / sponsor ID
- CWRU1402
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2002
- Primary completion
- Apr 2005 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 7 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rituximabRituximab IV over 3-6 hours.Treatment repeats every 21 days for 3-8 courses. | Biological | – |
| cyclophosphamideCyclophosphamide IV over 30 minutes. Treatment repeats every 21 days for 3-8 courses. | Drug | – |
| doxorubicin hydrochlorideDoxorubicin IV over 5 minutes. Treatment repeats every 21 days for 3-8 courses. | Drug | – |
| prednisoneOral prednisone on days 1-5. Treatment repeats every 21 days for 3-8 courses. | Drug | – |
| vincristine sulfateVincristine IV over 5 minutes on day 1. Treatment repeats every 21 days for 3-8 courses. | Drug | – |
| microarray analysisgenetic testing | Genetic | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omer N. Koc, MD study chair
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rituximab, cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2010.