Bortezomib in Treating Patients With Myelodysplastic Syndromes

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with myelodysplastic syndromes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: Bortezomib

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