LymphomaPhase 2NCT00182637
Bortezomib in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma
A Phase 2 study testing bortezomib in people with Lymphoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- bortezomib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Sep 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
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- 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
Who cannot join
- 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
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- concurrent immunotherapy
- concurrent chemotherapy
- concurrent steroid dose > 10 mg/day of prednisone or its equivalent
- concurrent radiotherapy
- concurrent surgery for the malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
About this study
Official title: A Phase II Study of Bortezomib (VELCADE®) in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)
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.
Read the 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.
- Conditions
- Lymphoma
- Being tested
- bortezomib
- 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
- Medical subject headings
- Lymphoma, Mycosis Fungoides, Sezary Syndrome, Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
| Study group | Role | What they receive |
|---|---|---|
| bortezomib | Experimental | Not described Receives: Drug: bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate After 2 Courses of Treatment
Measured: 2 months
Secondary outcomes (2)
Time to Progression
Measured: 2 years
Toxicity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Lauren C. Pinter-Brown, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182637
- Sponsor's protocol ID
- CDR0000439458
- Other IDs
- UCLA-0405014-02, MILLENNIUM-VEL-04-103
- Status last verified
- Jan 2016
- First submitted
- 15 Sep 2005
- Last updated
- 3 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Bortezomib (VELCADE®) in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)
- ClinicalTrials.gov ID
- NCT00182637
- Acronym / sponsor ID
- CDR0000439458
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Jul 2004
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 17 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bortezomib | Experimental | Drug: bortezomib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (11 listed)
- history of myelodysplastic syndromes
- evidence of CNS disease
- pregnant or nursing
- peripheral neuropathy ≥ grade 2
- hypersensitivity to bortezomib, boron, or mannitol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bortezomib | Drug | bortezomib |
Primary outcome
Overall Response Rate After 2 Courses of Treatment
Time frame: 2 months
2 secondary outcomes
Time to Progression
Time frame: 2 years
Toxicity
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren C. Pinter-Brown, MD principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bortezomib in people with Lymphoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate After 2 Courses of Treatment (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.