Belinostat in Treating Patients With Myelodysplastic Syndromes

NCT00357162 | Completed Phase 2 Results

• 8 other identifiers: NCI-2009-00143MAYO-MC0581NCI-7258CDR0000489197MC05817258P30CA015083N01CM62205
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well belinostat works in treating patients with myelodysplastic syndromes. Belinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

Conditions

de Novo Myelodysplastic Syndromes; Previously Treated Myelodysplastic Syndromes; Secondary Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

• Number of Confirmed Responses (Complete Response, Partial Response, or Hematologic Improvement) Noted on 2 Consecutive Evaluations at Least 4 Weeks Apart

  Complete Response (CR) A CR is defined as a participant with bone marrow showing less than 5% myeloblasts with no evidence of dysplasia and with adequate peripheral blood counts for at least 2 months (hemoglobin \> 11 g/dl, neutrophils ≥ 1500/mm3, platelets ≥ 100,000/mm3) and with no blasts in the peripheral. Partial Response (PR) All the CR criteria except bone marrow blasts decreased by ≥ 50% over pretreatment, or a less advanced WHO classification than pretreatment. Hematologic Improvement (HI) A 2g/dl increase in hemoglobin for participants with \<11g/dl hemoglobin at pretreatment, or an increase of \>30,000/mm\^3 platelets for participants with \<100,000/mm\^3 at pretreatment, or a 100% increase in neutrophil counts for participants with \<1500/mm\^3 at pretreatment

  12 weeks

Secondary Outcomes (4)

• Time to Progression

  Time from registration to the date of progression or last follow-up, assessed up to 3 years

• Overall Survival

  From date of registration to the date of last follow-up or death due to any cause, assessed up to 3 years

• Duration of Response

  From the date of documented response until the date of progression or last follow-up, assessed up to 3 years

• Toxicity of Belinostat in Patients With Myelodysplastic Syndrome

  Prior to each course (every 21 days), and every 3 months for up to 3 years after completion of study treatment

Study Arms (1)

Treatment (enzyme inhibitor therapy)

EXPERIMENTAL

Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Drug: belinostat

Interventions

belinostat DRUG

Given IV

Also known as: PXD101

Treatment (enzyme inhibitor therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed myelodysplastic syndromes (MDS)
• De novo or secondary MDS
• Patients with \< 5 % bone marrow blasts must meet ≥ 1 of the following criteria:
• Symptomatic anemia with either hemoglobin \< 10.0 g/dL or required RBC transfusions within the past 3 months
• Thrombocytopenia with ≥ 2 platelet counts \< 50,000/mm³ or significant hemorrhage requiring platelet transfusions
• Neutropenia with ≥ 2 absolute neutrophil counts \< 1,000/mm³
• No acute myeloid leukemia (≥ 20% bone marrow blasts)
• ECOG performance status 0-2
• Life expectancy \> 12 weeks
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST ≤ 2 times ULN
• Creatinine ≤ 2.0 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

belinostat

Results Point of Contact

• Title: Amanda Cashen, M.D.
• Organization: Washington University

acashen@im.wustl.edu

Study Officials

• Amanda Cashen

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2006
• First Posted: July 27, 2006
• Study Start: May 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 20, 2014
• Results First Posted: March 20, 2013

Record last verified: 2011-12

Locations

US (1)