Know Cancer

or
forgot password

Phase II Study of a Proteasome Inhibitor, PS-341 (NSC 681239) in Chronic Myelogenous Leukemia (CML) in Chronic or Accelerated Phase


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

Phase II Study of a Proteasome Inhibitor, PS-341 (NSC 681239) in Chronic Myelogenous Leukemia (CML) in Chronic or Accelerated Phase


OBJECTIVES:

- Determine the efficacy of bortezomib, in terms of response rate, duration of response,
and survival of patients with Philadelphia chromosome-positive chronic myelogenous
leukemia in chronic or accelerated phase.

- Assess the toxicity of this drug in these patients.

OUTLINE: Patients receive bortezomib intravenous (IV) over 3-5 seconds twice weekly on weeks
1-2. Treatment repeats every 3 weeks for up to 12 courses in the absence of disease
progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 5-30 patients will be accrued for this study within 15-30
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of Philadelphia (Ph) chromosome-positive chronic myelogenous leukemia (CML)
in chronic or accelerated phase, defined as having any of the following:

- Peripheral blood (PB) or bone marrow (BM) blasts at least 10% but less than 30%

- PB or BM blasts and promyelocytes at least 20%

- PB or BM basophils at least 20%

- Progressive splenomegaly (at least 10 cm confirmed twice at least 4 weeks apart
or 50% increase in splenomegaly over 4 weeks)

- Clonal evolution defined as the presence of additional cytogenetic abnormalities
other than the Ph chromosome

- Thrombocytopenia (platelet count less than 100,000/mm^3) unrelated to therapy

- Hemoglobin less than 7 g/dL unrelated to therapy or bleeding

- Failed prior treatment with imatinib mesylate or intolerant, unable, or unwilling to
receive it

- Ineligible for higher-priority or higher-efficacy regimens or protocols

- No blastic phase CML

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy:

- At least 18 weeks

Hematopoietic:

- See Disease Characteristics

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance greater than 60 mL/min

Other:

- No other concurrent illness that would preclude study entry

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No more than 2 prior cytotoxic regimens in addition to imatinib mesylate and/or
hydroxyurea

- At least 4 weeks since prior chemotherapy and recovered

- Concurrent hydroxyurea and/or anagrelide allowed during first 2 courses

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 4 weeks since prior radiotherapy and recovered

Surgery:

- Not specified

Other:

- See Disease Characteristics

- See Chemotherapy

- At least 24 hours since prior imatinib mesylate

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Jorge Cortes, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000068872

NCT ID:

NCT00023881

Start Date:

July 2001

Completion Date:

March 2005

Related Keywords:

  • Leukemia
  • relapsing chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • chronic myelogenous leukemia, BCR-ABL1 positive
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

MD Anderson Cancer Center at University of TexasHouston, Texas  77030-4009