Clinical trial NCT00182637: Bortezomib in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma
Official title: A Phase II Study of Bortezomib (VELCADE®) in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: 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
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2005-09-16
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Bortezomib may stop the growth of tumor 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 relapsed or refractory cutaneous T-cell lymphoma.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Response Rate After 2 Courses of Treatment
timeFrame: 2 months
Secondary outcomes:
measure: Time to Progression
timeFrame: 2 years
measure: Toxicity
timeFrame: 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center at UCLA
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Lauren C. Pinter-Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: