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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.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02215
- Beth Israel Deaconess Medical Center
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Vermont
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Burlington, Vermont, Verenigde Staten, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Masker: Geen (open label)
Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: Robin Joyce, MD, Beth Israel Deaconess Medical Center
Studie record data
Bestudeer belangrijke data
Studie start
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
- B-cel chronische lymfatische leukemie
- stadium 0 chronische lymfatische leukemie
- stadium I chronische lymfatische leukemie
- stadium III graad 1 folliculair lymfoom
- stadium III graad 2 folliculair lymfoom
- stadium IV graad 1 folliculair lymfoom
- stadium IV graad 2 folliculair lymfoom
- stadium I graad 1 folliculair lymfoom
- stadium I graad 2 folliculair lymfoom
- aaneengesloten stadium II graad 1 folliculair lymfoom
- aaneengesloten stadium II graad 2 folliculair lymfoom
- niet-aangrenzend stadium II graad 1 folliculair lymfoom
- niet-aangrenzend stadium II graad 2 folliculair lymfoom
- niet-aangrenzend stadium II klein lymfocytisch lymfoom
- niet-aaneengesloten stadium II marginale zone lymfoom
- stadium I marginale zone lymfoom
- stadium I klein lymfocytisch lymfoom
- stadium III klein lymfocytisch lymfoom
- stadium III marginale zone lymfoom
- stadium IV klein lymfocytisch lymfoom
- stadium IV marginale zone lymfoom
- aangrenzend stadium II marginale zone lymfoom
- aaneengesloten stadium II klein lymfocytisch lymfoom
- extranodale marginale zone B-cellymfoom van mucosa-geassocieerd lymfoïde weefsel
- nodale marginale zone B-cellymfoom
- milt marginale zone lymfoom
- stadium II chronische lymfatische leukemie
- stadium III chronische lymfatische leukemie
- stadium IV chronische lymfatische leukemie
- Waldenström macroglobulinemie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Neoplasmata
- Lymfoproliferatieve aandoeningen
- Lymfatische ziekten
- Immunoproliferatieve aandoeningen
- Leukemie, Lymfoïde
- Leukemie, B-cel
- Lymfoom
- Leukemie
- Lymfoom, non-Hodgkin
- Leukemie, lymfatische, chronische, B-cel
- Fysiologische effecten van medicijnen
- Anti-infectieuze middelen
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Angiogenese-remmers
- Angiogenese modulerende middelen
- Groei stoffen
- Groeiremmers
- Antibacteriële middelen
- Leprostatische middelen
- Thalidomide
Andere studie-ID-nummers
- BIDMC-W-01-0384-FB
- CDR0000258419 (Register-ID: PDQ (Physician Data Query))
- NEDH-W-01-0384-FB
- BIDMC-2001-P-001950
- NCI-V02-1714
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