|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 2, 2001 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | December 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00010192 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Rituximab Plus Interleukin-2 in Treating Patients With Hematologic Cancer | ||||
| Official Title ICMJE | A Phase I Trial Of Rituximab And Interleukin-2 | ||||
| Brief Summary | RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining rituximab with interleukin-2 may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of rituximab plus interleukin-2 in treating patients who have hematologic cancer. |
||||
| Detailed Description | OBJECTIVES:
OUTLINE: This is a dose-escalation study of intermediate-dose pulse interleukin-2 (IL-2). Patients receive rituximab IV on days 1, 8, 15, and 22. Patients then receive low-dose IL-2 subcutaneously (SC) on days 29-39, 43-53, 57-67, and 71-81, and intermediate-dose IL-2 SC on days 40-42, 54-56, 68-70, and 82-84. Cohorts of 3-6 patients receive escalating doses of intermediate-dose pulse IL-2 until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 1 year. |
||||
| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00010192 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068454, OSU-00H0223, OSU-0037, NCI-130 | ||||
| Study Sponsor ICMJE | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | October 2003 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||