|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||||||
| Brief Title † | Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin's Lymphoma | ||||||||
| Official Title † | A Phase I/II Trial of Fenretinide (4-HPR) + Rituximab in Patients With B-Cell Lymphoma | ||||||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving fenretinide together with rituximab may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of fenretinide and to see how well it works when given together with rituximab in treating patients with B-cell non-Hodgkin's lymphoma. |
||||||||
| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a phase I, dose-escalation study of fenretinide followed by a phase II study of fenretinide and rituximab.
Cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed at 3 and 6 months and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study. |
||||||||
| Study Phase | Phase I, Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Open Label | ||||||||
| Primary Outcome Measure † | Maximum tolerated dose at 1 month [ Designated as safety issue: Yes ] Response rate [ Designated as safety issue: No ] |
||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Lymphoma | ||||||||
| Intervention † | Drug: fenretinide Drug: rituximab |
||||||||
| MEDLINE PMIDs | |||||||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 52 | ||||||||
| Start Date † | February 2006 | ||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00288067 | ||||||||
| Organization ID | CDR0000456502 | ||||||||
| Secondary IDs †† | WU-NCI-6957, NCI-6957, UWCC-UW-6071, UWCC-06-0644-H/A | ||||||||
| Study Sponsor † | University of Washington | ||||||||
| Collaborators †† | National Cancer Institute (NCI) | ||||||||
| Investigators † |
|
||||||||
| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | March 2008 | ||||||||
| First Received Date † | February 6, 2006 | ||||||||
| Last Updated Date | May 23, 2008 | ||||||||