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Study of Velcade and Thalidomide in Patients With Myelodysplasia

7. marts 2008 opdateret af: Massachusetts General Hospital

Phase I Dose Escalation Trial of Bortezomib in Combination With Thalidomide in Patients With Myelodysplasia

The purpose of this study is to find out what the maximal tolerated dose of Velcade can be given with thalidomide in patients with myelodysplasia.

Studieoversigt

Status

Afsluttet

Betingelser

Myelodysplastisk syndrom

Intervention / Behandling

Medicin: bortezomib

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

Interventionel

Tilmelding

Fase

Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Massachusetts
  - Boston, Massachusetts, Forenede Stater, 02114
    - Massachusetts General Hospital
  - Boston, Massachusetts, Forenede Stater, 02115
    - Dana Farber Cancer Institute
  - Boston, Massachusetts, Forenede Stater, 02115
    - Beth Israel Deaconess Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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
The primary objective is to establish the maximally tolerated dose of bortezomib that can be administered with thalidomide in patient with myelodysplasia.

Sekundære resultatmål

Resultatmål
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.
Determine the toxicity profile of bortezomib when used in combination with thalidomide for patients with myelodysplasia.
Determine the relationship between NF-kB expression and clinical response to bortezomib and thalidomide.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Massachusetts General Hospital

Samarbejdspartnere

Dana-Farber Cancer Institute

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Efterforskere

Ledende efterforsker: Karen Ballen, M, Massachusetts General Hospital, Harvard University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2005

Studieafslutning

1. april 2007

Datoer for studieregistrering

Først indsendt

30. december 2005

Først indsendt, der opfyldte QC-kriterier