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A Phase II Study of Bortezomib (VELCADE®) in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Phase II Study of Bortezomib (VELCADE®) in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)


OBJECTIVES:

- Determine the response rates (complete response and partial response) and duration of
response in patients with relapsed or refractory cutaneous T-cell lymphoma treated with
bortezomib.

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

OUTLINE: This is an open-label study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats
every 21 days for up to 8 courses in the absence of disease progression or unacceptable
toxicity.

After completion of study treatment, patients are followed at 1 month and then at least
every 3 months for 2 years or until disease progression.

PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.


Inclusion Criteria:



- Histologically confirmed cutaneous T-cell lymphoma, including mycosis
fungoides/Sézary syndrome

- Stage IB-IV disease

- Relapsed or refractory disease OR intolerant to ≥ 1 prior systemic therapy

- Measurable disease by radiological imaging or clinical finding

- Age Over 18

- Performance status Karnofsky 70-100%

- Hematopoietic

- WBC > 2,000/mm^3

- Absolute neutrophil count > 1,500/mm^3

- Platelet count > 75,000/mm^3

- Hemoglobin > 8.0 g/dL

- Hepatic

- Bilirubin < 2 times upper limit of normal (ULN)

- AST and ALT < 3 times ULN

- Renal

- Creatinine < 1.5 times ULN

- Creatinine clearance ≥ 30 mL/min

- Negative pregnancy test

- Fertile patients must use effective contraception

- More than 3 months since prior high-dose chemotherapy

- More than 30 days since prior and no other concurrent investigational drugs

Exclusion Criteria:

- history of myelodysplastic syndromes

- evidence of CNS disease

- pregnant or nursing

- peripheral neuropathy ≥ grade 2

- hypersensitivity to bortezomib, boron, or mannitol

- serious medical condition or psychiatric illness that would preclude study
participation

- concurrent immunotherapy

- concurrent chemotherapy

- concurrent steroid dose > 10 mg/day of prednisone or its equivalent

- concurrent radiotherapy

- concurrent surgery for the malignancy

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate after 2 courses of treatment

Outcome Time Frame:

2 months

Safety Issue:

No

Principal Investigator

Lauren C. Pinter-Brown, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000439458

NCT ID:

NCT00182637

Start Date:

July 2004

Completion Date:

September 2010

Related Keywords:

  • Lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • stage I mycosis fungoides/Sezary syndrome
  • stage II mycosis fungoides/Sezary syndrome
  • stage III mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • stage I cutaneous T-cell non-Hodgkin lymphoma
  • stage II cutaneous T-cell non-Hodgkin lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

Name

Location
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781