- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00271804
Study of Velcade and Thalidomide in Patients With Myelodysplasia
Phase I Dose Escalation Trial of Bortezomib in Combination With Thalidomide in Patients With Myelodysplasia
Studieoversigt
Detaljeret beskrivelse
Initial studies using Velcade in myelodysplasia with early results demonstrating that 35% had a partial response and 25% had stable disease. The combination of Velcade and thalidomide has been studied in patients with multiple myeloma, but not in patients with myelodysplasia. The CRR in the MM patients was 22%, with a good safety profile.
This is a phase 1, prospective, open-label, dose escalation study to evaluate the DLT and MTD of velcade with given in combination with thalidomide in patients with myelodysplasia. Treatment will be given as an outpatient. Patients will receive 4 days of Velcade (days 1, 4, 8, 11) and 21 days of thalidomide 50 mg/day for each 21 day cycle. There will be 3 cohorts of 3-6 patients each, plus 10 additional patients. The tree dose levels ill be 0.7, 1.0 and 1.3 mg/m2. Patients may continue to be treated up to 6 cycles. Cycles 2-6 will start within 2 weeks of completion of the previous cycle. Disease response will be evaluated after cycle 3 and 6.
Undersøgelsestype
Tilmelding
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Forenede Stater, 02115
- Dana Farber Cancer Institute
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Boston, Massachusetts, Forenede Stater, 02115
- Beth Israel Deaconess Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Myelodysplastic syndrome with a IPSS score of 0.5 or greater
- May have had prior chemo/radiotherapy for another malignancy or myelodysplasia
- ECOG performance status of 0-2
- Life expectancy greater than 3 months
- Total bilirubin </+ 2xULN
- ALT and AST </+ 3xULN
- Calculated creatinine clearance > 30 ml/min
- Use of appropriate method of contraception during the study
- ANC > 0.5 x 10(9)
- Platelet count > 30 x 10(9)
- Consideration of treatment with 5 azacytidine is encouraged by not required
Exclusion Criteria:
- Ejection fraction < 40%
- myocardial infarction within 6 months of enrollment of New York Heart Association Class III or IV heart failure, uncontrolled angina, uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Women who are pregnant or breast-feeding
- Major surgery within 4 weeks prior to enrollment
- >/= grade 2 peripheral neuropathy within 14 days prior to enrollment
- Uncontrolled intercurrent illness
- Serious medical or psychiatric illness that could potentially interfere with the completion of treatment
- Hypersensitivity to bortezomib, boron, or mannitol
- Received an investigational drug within 14 days of enrollment
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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The primary objective is to establish the maximally tolerated dose of bortezomib that can be administered with thalidomide in patient with myelodysplasia.
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Sekundære resultatmål
Resultatmål |
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Assess efficacy in terms of the number of patients attaining a 50% reduction in blast percentage, or 50% reduction in number of red blood cell and/or platelet transfusions.
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Determine the toxicity profile of bortezomib when used in combination with thalidomide for patients with myelodysplasia.
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Determine the relationship between NF-kB expression and clinical response to bortezomib and thalidomide.
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Karen Ballen, M, Massachusetts General Hospital, Harvard University
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 04-381
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