Lymphoma
Conditions
Keywords
recurrent mycosis fungoides/Sezary syndrome, recurrent cutaneous T-cell non-Hodgkin lymphoma
Brief 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 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.
Interventions
BIOLOGICALRFT5-dgA immunotoxin
OTHERimmunohistochemistry staining method
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate - Cutaneous T Cell Lymphoma (CTCL) | Once a week for seven weeks | Response rate of patients with relapsed/refractory Cutaneous T Cell Lymphoma (CTCL) following treatment with IMTOX25. |
Countries
United States
Participant flow
Recruitment details
Consent Withdrawn After Treatment Started. Pt withdrew from treatment due to side effects
Participants by arm
| Arm | Count |
|---|---|
| IMTOX25 at 2mg/m²/Dose 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.
RFT5-dgA immunotoxin
fluorescence activated cell sorting
immunohistochemistry staining method | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Response Rate - Cutaneous T Cell Lymphoma (CTCL)
Response rate of patients with relapsed/refractory Cutaneous T Cell Lymphoma (CTCL) following treatment with IMTOX25.
Time frame: Once a week for seven weeks
Population: Consent Withdrawn After Treatment Started Pt withdrew from treatment due to side effects.