- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00667017
RFT5-dgA Immunotoxin in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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-
Texas
-
Dallas, Texas, Forente stater, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Response Rate - Cutaneous T Cell Lymphoma (CTCL)
Tidsramme: Once a week for seven weeks
|
Response rate of patients with relapsed/refractory Cutaneous T Cell Lymphoma (CTCL) following treatment with IMTOX25.
|
Once a week for seven weeks
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Simrit Parmar, MD, Simmons Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SCCC-02407
- CDR0000594170 (Registeridentifikator: PDQ (Physician Data Query))
- SCCC-122007-014
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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