- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00052416
Thalidomide in Treating Patients With Asymptomatic, Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Thalidomide in Indolent Non-Hodgkin's Lymphoma: A Feasibility Study
RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase I trial to determine the effectiveness of thalidomide in treating patients who have asymptomatic, indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Study Overview
Detailed Description
OBJECTIVES:
- Determine the feasibility, in terms of toxicity and patient compliance, of thalidomide in patients with asymptomatic, indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
- Determine the event-free and progression-free survival of patients treated with this drug.
- Determine disease response and time to next treatment in patients treated with this drug.
- Determine the quality of life of patients treated with this drug.
OUTLINE: Patients receive oral thalidomide once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, monthly during study, and at the end of the study.
PROJECTED ACCRUAL: A total of 30-36 patients will be accrued for this study within 2 years.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Vermont
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Burlington, Vermont, United States, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed indolent lymphoma or leukemia of one of the following subtypes:
- Chronic lymphocytic leukemia
- Follicular center lymphoma (grade I or II)
- Lymphoplasmacytic lymphoma
- Marginal zone lymphoma (nodal, extranodal, or splenic)
- Small lymphocytic lymphoma
- Waldenstrom's macroglobulinemia
- Any stage of disease allowed
- No hairy cell leukemia
- No T-cell lymphomas
- No prior treatment for lymphoma/leukemia
Considered appropriate for expectant management
- Must not require cytotoxic therapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Hemoglobin greater than 10.0 g/dL
- Platelet count greater than 75,000/mm^3
Hepatic
- Bilirubin no greater than 2 times normal
- AST and ALT no greater than 2 times normal
Renal
- Creatinine no greater than 2.0 mg/dL
Cardiovascular
- No uncontrolled congestive heart failure
- No New York Heart Association class III or IV heart disease
- No unstable coronary artery disease
- No myocardial infarction in the past 6 months
- No serious or uncontrolled arrhythmias
- No history of thromboembolic disease
Pulmonary
- No asthma or chronic obstructive pulmonary disease requiring the use of home oxygen or frequent oral steroids (prednisone greater than 20 mg per day for 5 days within the past 3 months)
Other
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Not planning to become pregnant in the next 2 years
- Fertile female patients must use 1 highly effective method and 1 additional effective method of contraception for 1 month prior to, during, and for 1 month after study participation
- Male patients must use effective barrier contraception during and for 1 month after study participation
- Willing and able to participate in the S.T.E.P.S. (System for Thalidomide Education and Prescribing Safety) program
- No contraindications to meeting the requirements of the S.T.E.P.S. program
- No other prior malignancy except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix
- No peripheral neuropathy
No poorly controlled diabetes defined by either of the following:
- Glycosylated hemoglobin greater than 8.0 g/dL
- Known end organ disease (i.e., nephropathy, retinopathy, or neuropathy)
- No other concurrent illness that would preclude study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Study Chair: Robin Joyce, MD, Beth Israel Deaconess Medical Center
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- B-cell chronic lymphocytic leukemia
- stage 0 chronic lymphocytic leukemia
- stage I chronic lymphocytic leukemia
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- noncontiguous stage II marginal zone lymphoma
- stage I marginal zone lymphoma
- stage I small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- contiguous stage II marginal zone lymphoma
- contiguous stage II small lymphocytic lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- stage II chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- Waldenström macroglobulinemia
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, Lymphoid
- Leukemia, B-Cell
- Lymphoma
- Leukemia
- Lymphoma, Non-Hodgkin
- Leukemia, Lymphocytic, Chronic, B-Cell
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Thalidomide
Other Study ID Numbers
- BIDMC-W-01-0384-FB
- CDR0000258419 (Registry Identifier: PDQ (Physician Data Query))
- NEDH-W-01-0384-FB
- BIDMC-2001-P-001950
- NCI-V02-1714
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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