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Study Summary
No. 2008-0077:.......Skin......Madeleine Duvic......Dermatology
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Study Summary Title
Study Summary
Number:
2008-0077
Study Title:A Phase I/II Study of A-dmDT390-bisFv (UCHT1) Fusion Protein
in Patients with Surface CD3+ Malignant T Cell Diseases
(FDA IND Number: 100712).
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Physician New Patient Referral
Name:Madeleine DuvicPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:DermatologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-4578
Contact us about clinical trials
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General Information
Disease Group:SkinSupported By:Angiimune
Phase of Study:Phase I/Phase IIReturn
Visit:
1 return follow-up visit after hospitalization thereafter, the visits are
standard of care
Treatment
Agents:
A-dmDT390-bisFv (UCHT1)Home Care:n/a
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
5 days (4 day administration cycle)
Description/
Intervention:
The goal of this clinical research study is to learn the safety and efficacy of
AdmDT390-bisFv (UCHT1) in patients with a CD3 positive T-cell cancer.
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Study Objectives / Outcomes
Primary:
Determine the maximal tolerated dose (MTD) of A-dmDT390-bisFv(UCHT1) fusion protein as a bolus infusion on days 1-4 in patients with CD3+ T-cell malignant diseases.
    Secondary Objectives:
    Define the dose-limiting toxicities (DLT) of this A-dmDT390-bisFv(UCHT1) regimen in patients with CD3+ T-cell malignant diseases.

    Measure the pharmacokinetics and immune responses to this course of bolus infusions of A-dmDT390-bisFv(UCHT1) fusion protein.

    Evaluate responses and correlate with the in vitro sensitivity of patient malignant T-cells to A-dmDT390-bisFv(UCHT1).

    Determine the extent and kinetics of resting and malignant T-cell depletion and repopulation in the treatment groups by flow cytometry of samples obtained from blood and marrow aspirations.
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    Study Status Information
    Study Activation / Registration Date:05/29/2009
    IRB Review and Approval Date:09/24/2008
    Study Type:Phase Ii Or Phase I/Ii
    Recruitment Status:Open
    Projected Accrual:65
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    Enrollment Eligibility
    If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

    Inclusion Criteria:1) All patients must have either surface CD3+ T-cell malignant diseases diagnosed by morphologic, histochemical or cell surface marker criteria. Patients with T-ALL must have surface CD3 on at least 80% of the lymphoblasts as determined by flow cytometry.

    2) Patients with CD3+ T-cell malignant diseases must have failed or be refractory to approved therapeutic agents or choose to decline or defer, after adequate informed consent, clinically meaningful palliative therapy.

    3) Age >/= 18 years.

    4) Patients >/= 12 years of age with CD3+ T-cell malignant diseases must have failed or be refractory to approved therapeutic agents [applies only for subjects enrolled at Texas Children' Hospital].

    5) Patients >/= 12 years may be accrued beginning at dose level 2.5 mcg/kg.[applies only for subjects enrolled at Texas Children' Hospital].

    6) Patients must have a performance status of </= 2 on Eastern Cooperative Oncology Group scale. Patients must have fully recovered from toxicity of prior chemotherapy or radiation therapy.

    7) Patients must have bilirubin </= 1.5 mg/dL, transaminases < 2.5 X ULN, albumin >/= 3 gm/dL, creatinine </= 2.0 mg/dL, adequate pulmonary function by physical exam and pulse oxometry and adequate cardiac reserve (EF >/= 50% normal).

    8) Pre-treatment anti-A-dmDT390-bisFv (UCHT1) level is </= 3 micrograms/mL.

    9) Patients must give written informed consent prior to registration.

    10) Females and males must be willing to use an approved form of birth control while on this study and for 2 weeks after completion.

    Exclusion Criteria:1) Failure to meet any of the criteria set forth in inclusion requirements.

    2) Inability to give informed consent because of psychiatric problems, or complicated medical problems.

    3) Serious concurrent medical problems, uncontrolled infections, or disseminated intravascular coagulopathy (DIC).

    4) Central Nervous System leukemia.

    5) Patients who have had a myocardial infarction within the past six months.

    6) Pregnant or nursing women will be excluded from study.

    7) Patients with allergies to diphtheria toxoid or diphtheria antitoxin will be excluded as Corynebacterium diphtheriae and its toxin are both considered potentially fatal in all humans

    8) Preexisting cardiovascular disease (e.g. congestive heart failure, coronary artery disease, cardiomyopathy, myocardial infarction with the past 3 months, arrhythmia) requiring ongoing treatment

    9) History of congestive heart failure

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    Links
    Registration Number: NCT00611208
    Study Information on Clinical Trials Registry (clinicaltrials.gov)

    Other Links:
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    Results


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