Lymphoma
Conditions
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
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.
Interventions
DRUGbortezomib
Sponsors
Millennium Pharmaceuticals, Inc.
Jonsson Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate After 2 Courses of Treatment | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| Time to Progression | 2 years |
| Toxicity | 2 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bortezomib administration of bortezomib | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Disease Progression | 1 |
Baseline characteristics
| Characteristic | Bortezomib |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Overall Response Rate After 2 Courses of Treatment
Time frame: 2 months
Population: Only two subjects completed the trial. Study closed early due to lack of enrollment. No analysis performed.
Secondary
Time to Progression
Time frame: 2 years
Population: Only two subjects completed the trial. Study closed early due to lack of enrollment. No analysis performed.
Secondary
Toxicity
Time frame: 2 years
Population: Only two subjects completed the trial. Study closed early due to lack of enrollment. No analysis performed.