LymphomaPhase 2NCT00667017
RFT5-dgA Immunotoxin in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma
A Phase 2 study testing RFT5-dgA immunotoxin, fluorescence activated cell sorting and immunohistochemistry staining method in people with Lymphoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
RATIONALE: Immunotoxins, such as RFT5-dgA immunotoxin (also called anti-CD25 immunotoxin IMTOX25), can find certain cancer cells and kill them without harming normal cells. PURPOSE: This phase II trial is studying the side effects of anti-CD25 immunotoxin IMTOX25 and how well it works in treating patients with… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- RFT5-dgA immunotoxin, fluorescence activated cell sorting and immunohistochemistry staining method
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2008to Feb 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed cutaneous T-cell non-Hodgkin lymphoma (CTCL)
- Relapsed or refractory disease, meeting 1 of the following criteria:
- Progression of disease following 2 prior chemotherapies
- Failure to respond to the second prior chemotherapy
- Measurable disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 3 months
- Serum creatinine < 1.5 times upper limit of normal (ULN)
- Serum AST/ALT < 2.5 times ULN
- Total bilirubin ≤ 2.0 mg/dL (< 3.0 mg/dL in patients with Gilbert syndrome)
- WBC count ≥ 3,000/mm³
- Platelet count ≥ 100,000/mm³
- Serum albumin > 2.5 g/dL
- LVEF ≥ 45% by 2-D ECHO or MUGA scan
- Human antimurine antibody < 1 μg/mL
- Patients with a history of electrocardiogram abnormalities, symptoms of cardiac ischemia, or arrhythmias must have a normal cardiac stress test (i.e., stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test)
- Must be willing to undergo venipuncture and central line placement
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No HBV surface antigen, HCV, or HIV antibody positivity
- No autoimmune disease or immunodeficiency (i.e., HIV)
- No history of uncontrolled concurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Ongoing or active cardiac disease (i.e., congestive heart failure, unstable angina pectoris, or cardiac arrhythmia)
- Psychiatric illness and/or social situation that would preclude study compliance
- No other malignancies except treated basal cell or squamous cell carcinoma of the skin, or treated carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 3 weeks since prior systemic therapy for CTCL
- More than 6 months since prior chronic steroid therapy or chronic anti-coagulation therapy
- No prior therapy with anti-CD25 immunotoxin IMTOX25 and/or Ontak
- No other concurrent cancer chemotherapy, experimental therapy, investigational agent, or immunomodulating agent (including steroids)
Trial locations and contacts
1 site in 1 country.
United States1 site
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
About this study
Official title: Phase II Study of IMTOX25 in Relapsed/Refractory Cutaneous T-Cell Lymphoma
RATIONALE: Immunotoxins, such as RFT5-dgA immunotoxin (also called anti-CD25 immunotoxin IMTOX25), can find certain cancer cells and kill them without harming normal cells.
PURPOSE: This phase II trial is studying the side effects of anti-CD25 immunotoxin IMTOX25 and how well it works in treating patients with relapsed or refractory cutaneous T-cell non-Hodgkin lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the response rate of patients with relapsed or refractory cutaneous T-cell non-Hodgkin lymphoma (CTCL) following treatment with RFT5-dgA immunotoxin (anti-CD25 immunotoxin IMTOX25) .
Secondary
- Determine whether responses correlate with the level of CD25+ expression on the CTCL tumor cells.
- Determine whether changes in the pre-treatment and the post-treatment levels of CD4+CD25+ Treg cells correlate with responses.
OUTLINE: Patients receive anti-CD25 immunotoxin IMTOX25 IV over 4 hours on days 1, 3, and 5. Treatment repeats every 6 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Tissue and blood samples are collected at baseline, and during study for CD25+ expression by fluorescent-activated cell sorter analysis, immunohistochemistry.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
- Conditions
- Lymphoma
- Being tested
- RFT5-dgA immunotoxin, fluorescence activated cell sorting, immunohistochemistry staining method
- Keywords
- recurrent mycosis fungoides/Sezary syndrome, 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.
RFT5-dgA immunotoxinBiological
fluorescence activated cell sortingOther
| Study group | Role | What they receive |
|---|---|---|
| IMTOX25 at 2mg/m²/dose | Experimental | Patients will receive IMTOX25 at 2mg/m²/dose, by IV administration, every other day for a total of 3 doses. A total of 6 cycles of treatment will be allowed. A cycle is equal to 6 weeks, with IMTOX25 infusion on Day 1, 3 and 5, followed by a 5 week rest period. Receives: Biological: RFT5-dgA immunotoxin; Other: fluorescence activated cell sorting; Other: immunohistochemistry staining method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate - Cutaneous T Cell Lymphoma (CTCL)
Response rate of patients with relapsed/refractory Cutaneous T Cell Lymphoma (CTCL) following treatment with IMTOX25.
Measured: Once a week for seven weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study start7 Nov 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: Slow accrual.
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 University of Texas Southwestern Medical 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simrit Parmar, MD, Principal investigator, Simmons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667017
- Sponsor's protocol ID
- SCCC-02407
- Other IDs
- CDR0000594170, SCCC-122007-014
- Status last verified
- Nov 2018
- First submitted
- 24 Apr 2008
- Last updated
- 14 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of IMTOX25 in Relapsed/Refractory Cutaneous T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00667017
- Acronym / sponsor ID
- SCCC-02407
- Conditions
- Lymphoma
- Keywords
- recurrent mycosis fungoides/Sezary syndrome, recurrent cutaneous T-cell non-Hodgkin lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 7 Nov 2008 (actual)
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 25 Apr 2008 (estimated)
- Results
- Posted 14 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Immunotoxins, such as RFT5-dgA immunotoxin (also called anti-CD25 immunotoxin IMTOX25), can find certain cancer cells and kill them without harming normal cells.
PURPOSE: This phase II trial is studying the side effects of anti-CD25 immunotoxin IMTOX25 and how well it works in treating patients with relapsed or refractory cutaneous T-cell non-Hodgkin lymphoma.
Detailed description
OBJECTIVES:
Primary
- Determine the response rate of patients with relapsed or refractory cutaneous T-cell non-Hodgkin lymphoma (CTCL) following treatment with RFT5-dgA immunotoxin (anti-CD25 immunotoxin IMTOX25) .
Secondary
- Determine whether responses correlate with the level of CD25+ expression on the CTCL tumor cells.
- Determine whether changes in the pre-treatment and the post-treatment levels of CD4+CD25+ Treg cells correlate with responses.
OUTLINE: Patients receive anti-CD25 immunotoxin IMTOX25 IV over 4 hours on days 1, 3, and 5. Treatment repeats every 6 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Tissue and blood samples are collected at baseline, and during study for CD25+ expression by fluorescent-activated cell sorter analysis, immunohistochemistry.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMTOX25 at 2mg/m²/dose | Experimental | Biological: RFT5-dgA immunotoxin, Other: fluorescence activated cell sorting, Other: immunohistochemistry staining methodPatients will receive IMTOX25 at 2mg/m²/dose, by IV administration, every other day for a total of 3 doses. A total of 6 cycles of treatment will be allowed. A cycle is equal to 6 weeks, with IMTOX25 infusion on Day 1, 3 and 5, followed by a 5 week rest period. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| RFT5-dgA immunotoxin | Biological | IMTOX25 at 2mg/m²/dose |
| fluorescence activated cell sorting | Other | IMTOX25 at 2mg/m²/dose |
| immunohistochemistry staining method | Other | IMTOX25 at 2mg/m²/dose |
Primary outcome
Response Rate - Cutaneous T Cell Lymphoma (CTCL)
Time frame: Once a week for seven weeks
Response rate of patients with relapsed/refractory Cutaneous T Cell Lymphoma (CTCL) following treatment with IMTOX25.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- 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.
Simrit Parmar, MD principal investigator
Simmons 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 RFT5-dgA immunotoxin, fluorescence activated cell sorting and immunohistochemistry staining method in people with Lymphoma, run by University of Texas Southwestern Medical 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?
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: stopped early, as of the sponsor's last update on 14 Dec 2018. 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 14 Dec 2018). 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?
Response Rate - Cutaneous T Cell Lymphoma (CTCL) (time frame: Once a week for seven weeks). 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 14 Dec 2018.