Expired Study
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Los Angeles, California 90095


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000439458


NCT ID:

NCT00182637


Secondary ID:

P30CA016042


Study Acronym:


Brief Title:

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)


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Jonsson Comprehensive Cancer Center


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Maski


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

5


Enrollment Type:

Actual


Overall Contact Information

Official Name:Lauren C. Pinter-Brown, MD
Principal Investigator
Jonsson Comprehensive Cancer Center

Study Dates

Start Date:July 2004
Completion Date:September 2010
Completion Type:Actual
Primary Completion Date:September 2010
Primary Completion Type:Actual
Verification Date:August 2012
Last Changed Date:October 28, 2015
First Received Date:September 15, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Toxicity
Time Frame:2 years
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Time to progression
Time Frame:2 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Overall response rate after 2 courses of treatment
Time Frame:2 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:bortezomib
Arm Name:bortezomib

Study Arms

Study Arm Type:Experimental
Arm Name:bortezomib

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Jonsson Comprehensive Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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