Trials / Completed
CompletedNCT00022581
Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase II Trial of Thalidomide (NSC #66847, IND #48832) for Patients With Relapsed or Refractory Low Grade Non-Hodgkin's Lymphoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase II trial to study the effectiveness of thalidomide in treating patients who have relapsed or refractory low-grade non-Hodgkin's lymphoma. Thalidomide may stop the growth of non-Hodgkin's lymphoma by stopping blood flow to the tumor
Detailed description
PRIMARY OBJECTIVES: I. To estimate the response rate and time-to-progression (TTP) in previously treated patients with low grade non-Hodgkin's lymphoma treated with thalidomide. II. To evaluate the effect of thalidomide on microvascular density in the bone marrow of patients with low grade cell non-Hodgkin's lymphoma. III. To evaluate the effects of thalidomide on bFGF levels in serum and urine. 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.
Conditions
- Recurrent Grade 1 Follicular Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Grade 3 Follicular Lymphoma
- Recurrent Small Lymphocytic Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | thalidomide | Given orally |
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2001-07-01
- Primary completion
- 2004-12-01
- First posted
- 2003-01-27
- Last updated
- 2013-01-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00022581. Inclusion in this directory is not an endorsement.