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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00022581 |
Purpose
RATIONALE: Thalidomide may stop the growth of non-Hodgkin's lymphoma by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have relapsed or refractory low-grade non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: thalidomide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Thalidomide (NSC# 66847, IND# 48832) for Patients With Relapsed or Refractory Low Grade Non-Hodgkin's Lymphoma |
| Enrollment: | 25 |
| Study Start Date: | July 2001 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive oral thalidomide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed relapsed or refractory low-grade non-Hodgkin's lymphoma of 1 of the following subtypes:
Bidimensionally measurable disease
The following are not considered measurable:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Neurologic:
Other:
Regardless of fertility status:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Indiana | |
| Elkhart General Hospital | |
| Elkhart, Indiana, United States, 46515 | |
| Howard Community Hospital | |
| Kokomo, Indiana, United States, 46904 | |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | |
| La Porte, Indiana, United States, 46350 | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Saint Joseph Regional Medical Center | |
| South Bend, Indiana, United States, 46617 | |
| Memorial Hospital of South Bend | |
| South Bend, Indiana, United States, 46601 | |
| South Bend Clinic | |
| South Bend, Indiana, United States, 46617 | |
| United States, Kansas | |
| Menorah Medical Center | |
| Overland Park, Kansas, United States, 66209 | |
| Shawnee Mission Medical Center | |
| Shawnee Mission, Kansas, United States, 66204 | |
| United States, Michigan | |
| Lakeland Regional Cancer Care Center - St. Joseph | |
| St. Joseph, Michigan, United States, 49085 | |
| United States, Missouri | |
| Independence Regional Health Center | |
| Independence, Missouri, United States, 64050 | |
| Truman Medical Center - Hospital Hill | |
| Kansas City, Missouri, United States, 64108 | |
| St. Joseph Medical Center | |
| Kansas City, Missouri, United States, 64114 | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| North Kansas City Hospital | |
| Kansas City, Missouri, United States, 64116 | |
| Parvin Radiation Oncology | |
| Kansas City, Missouri, United States, 64116 | |
| Research Medical Center | |
| Kansas City, Missouri, United States, 64132 | |
| Saint Luke's Cancer Institute at Saint Luke's Hospital | |
| Kansas City, Missouri, United States, 64111 | |
| Saint Luke's East - Lee's Summit | |
| Lee's Summit, Missouri, United States, 64086 | |
| Liberty Hospital | |
| Liberty, Missouri, United States, 64068 | |
| Heartland Regional Medical Center | |
| Saint Joseph, Missouri, United States, 64506 | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |
| Saint Louis, Missouri, United States, 63110 | |
| Study Chair: | David L. Grinblatt, MD | NorthShore University HealthSystem Research Institute |
More Information
| Responsible Party: | Monica M Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00022581 History of Changes |
| Other Study ID Numbers: | CDR0000068832, U10CA031946, CALGB-50002 |
| Study First Received: | August 10, 2001 |
| Last Updated: | April 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent small lymphocytic lymphoma |
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Thalidomide Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |