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Study Summary
No. 2004-0892:.......Skin......Madeleine Duvic......Dermatology
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Study Summary Title
Study Summary
Number:
2004-0892
Study Title:Open-label, Dose escalation, followed by Open-label, Single Arm, Multi-center Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients with Mycosis Fungoides (stage IB-IVB) or Sézary Syndrome who are Refractory or Intolerant to Targretin® (bexarotene) and one other Standard Therapy
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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:713-745-1113
Contact us about clinical trials
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General Information
Disease Group:SkinSupported By:N/A
Phase of Study:Phase I/Phase IIReturn
Visit:
16 visits during 30 week period and every 8 weeks after until progressive
disease or until CD4 count reaches 350/mm3
Treatment
Agents:
Humax-CD4Home Care:n/a
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
n/a
Description/
Intervention:
The goal of this clinical research study is to look at the effectiveness of
HuMax-CD4 in treating patients with CTCL, also know as Mycosis Fungoides (MF)
or Sézary Syndrome (SS). The safety of this treatment will also be studied.
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Study Objectives / Outcomes
The primary objective is to determine the efficacy of HuMax-CD4 in patients with MF (stage IB - IVB) or Sézary Syndrome (SS) who are refractory or intolerant to treatment with Targretin® and one other standard therapy.

Secondary objectives are to explore safety and relief of symptoms and characterize the pharmacokinetic profile of HuMax-CD4 in patients with MF or Sézary Syndrome (SS) who are refractory or intolerant to treatment with Targretin® and one other standard therapy.
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Study Status Information
Study Activation / Registration Date:06/15/2005
IRB Review and Approval Date:01/19/2005
Study Type:Therapeutic
Recruitment Status:Open
Projected Accrual:70 patients will be enrolled in the second part of this study
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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) A biopsy compatible with the diagnosis of MF or SS with a CD4 positive phenotype within 6 months of study entry.

2) MF or SS stage IB to IVB (highest stage ever).

3) Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof), the other being the current standard therapy at each institution.

4) WHO performance status 0, 1, or 2

5) Age >/= 18 years

6) Following receipt of verbal and written information about the study, the patient must provide signed consent before any study related activity is carried out

Exclusion Criteria:1) Primary cutaneous anaplastic large cell lymphoma

2) Lymphomatoid papulosis

3) Histopathological evidence of sheets of large cells (from skin or nodes) or poorly differentiated tumors.

4) Prior treatment with Total Skin Electron Beam (TSEB) therapy within 6 months.

5) Prior treatment with Campath (alemtuzumab)

6) Prior treatment with more than three regimens of single agent chemotherapy

7) Prior treatment with pentostatin within 6 months.

8) Treatment within 4 weeks prior to visit 2 with topical Targretin®, skin directed therapies or systemic anticancer therapies, such as, but not limited to: Targretin® , UV-light therapy, local Electron Beam Therapy (EBT), extracorporal photo chemotherapy, methotrexate, bleomycin, cyclophosphamide, combination chemotherapy, oral retinoids, systemic glucocorticosteroids14, carmustine, nitrogen mustard, systemic vitamin A or etretinate

9) Treatment with topical glucocorticosterioids within 2 weeks prior to visit 2

10) Unwillingness or inability to avoid prolonged exposure to the sun or UV light sufficient to produce a mild erythema or thought by the investigator to likely modify the patient's disease

11) Concurrent or previous malignancies within the past five years except adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell skin carcinoma

12) Acute or chronic infectious disease requiring medication. Patients with a history of intermittent relapsing herpes simplex skin affection on prophylactic treatment with acyclovir or valacyclovir and patients taking dicloxillin for carriage of staphylococcus aureus may be included.

13) Significant concurrent, uncontrolled, or active medical condition including, but not limited to renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral or psychiatric disease

14) Screening blood laboratory values: hemoglobin < 8.5 g/dL, WBC </= 2.5 x 10(9) cells/L, platelets < 100 x 10(9) cells/L, ALT/AST > 3 times upper limit of normal, S-Creatinine > 1.5 mg/dL, CD3(+)CD4(+) cell count > 10000 cells/mm(3).

15) Known or positive serology for HIV

16) Known or positive serology for hepatitis B or C

17) Signs or symptoms of CNS involvement

18) Patients who are currently participating in any other trials or having received treatment with any experimental agent within 4 weeks prior to visit 1 (screening)

19) Prior treatment with anti-CD4 monoclonal antibodies

20) Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)

21) Breast feeding women or women with a positive pregnancy test at Visit 1

22) Women of childbearing potential not willing to use either hormonal birth control, an intrauterine device or double-barrier method for the entire study period

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Links
Registration Number: NCT00127881
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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