Know Cancer

or
forgot password

A Phase II Pilot Study of VELCADE in Patients With MDS


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Myelodysplastic Syndromes

Thank you

Trial Information

A Phase II Pilot Study of VELCADE in Patients With MDS


OBJECTIVES:

Primary

- Determine the efficacy of bortezomib, in terms of reduced cytopenia, in patients with
myelodysplastic syndromes.

- Determine the safety and toxic effects of this drug in these patients.

Secondary

- Determine changes in marrow blast percentage or karyotypic profile in patients treated
with this drug.

OUTLINE: This is an open-label study.

Patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days for
up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 1 year.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of myelodysplastic syndromes (MDS)

- Requires treatment or transfusion support for MDS, as indicated by 1 of the
following:

- Demonstrates transfusion or epoetin alfa dependence

- Transfusion dependence is defined as requiring ≥ 2 units of packed RBCs
within an 8-week period prior to study entry

- Hemoglobin < 11g/dL on 2 separate occasions 2 weeks apart

- No iron, cyanocobalamin (vitamin B_12), or folic acid deficiency or other
causes of anemia

- Must have 1 of the following FAB subtypes:

- Refractory anemia

- Refractory anemia with ringed sideroblasts

- Refractory anemia with excess blasts

- Secondary MDS (if ≥ 3 years since active primary cancer)

- No chronic myelomonocytic leukemia

- Not refractory to platelet transfusion support (i.e., inability to maintain platelet
count > 20,000/mm^3 with transfusion)

- No current acute myelogenous leukemia (e.g., > 30% blasts)

PATIENT CHARACTERISTICS:

Performance status

- Karnofsky 50-100%

Life expectancy

- At least 6 months

Hematopoietic

- See Disease Characteristics

Hepatic

- Bilirubin ≤ 2 mg/dL

- AST and ALT < 2 times upper limit of normal

Renal

- Creatinine clearance ≥ 30 mL/min

Cardiovascular

- No significant cardiovascular condition that would preclude study participation

- No uncontrolled hypertension

Pulmonary

- No significant pulmonary condition that would preclude study participation

Immunologic

- No serious concurrent infection

- Active infections must be adequately treated with antibiotics prior to study
entry

- No hypersensitivity to bortezomib, boron, or mannitol

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for up to 4 weeks after
completion of study treatment

- No peripheral neuropathy ≥ grade 2

- No uncontrolled seizure activity, as defined by no activity within the past year on
stable anticonvulsant medications

- No other malignancy within the past 3 years except adequately treated basal cell skin
cancer or carcinoma in situ of the cervix

- No endocrine, neurologic, or other systemic disease that would preclude study entry

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- No prior allogeneic bone marrow transplantation

- Concurrent transfusion support allowed

- Concurrent epoetin alfa or darbepoetin alfa allowed if initiated before start of
study therapy, dose is stable for ≥ 4 weeks, and dose is stable during study
participation

- No concurrent platelet growth factor support

- No concurrent thalidomide

Chemotherapy

- No concurrent chemotherapy

- No concurrent hydroxyurea

Endocrine therapy

- Concurrent corticosteroids for chronic autoimmune or inflammatory condition allowed
if initiated before start of study therapy and maintained on a stable or decreasing
dose

Other

- Recovered from all prior therapies

- At least 4 weeks since prior MDS therapy, except epoetin alfa, darbepoetin alfa,
filgrastim (G-CSF), pegfilgrastim (G-CSF), or transfusion support

- At least 30 days since prior investigational agents

- No prior bortezomib

- No other concurrent investigational agents

- No other concurrent therapy for MDS

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety as measured by NCI toxicity criteria after every course

Safety Issue:

Yes

Principal Investigator

Jane L. Liesveld, MD

Investigator Role:

Study Chair

Investigator Affiliation:

James P. Wilmot Cancer Center

Authority:

Unspecified

Study ID:

CDR0000449689

NCT ID:

NCT00262873

Start Date:

May 2005

Completion Date:

Related Keywords:

  • Myelodysplastic Syndromes
  • previously treated myelodysplastic syndromes
  • refractory anemia with excess blasts
  • refractory anemia with ringed sideroblasts
  • refractory anemia
  • secondary myelodysplastic syndromes
  • de novo myelodysplastic syndromes
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642