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Open Label, Dose Escalation, Followed by Open Label,Single Arm Clinical Trial of HuMax-CD4 in Patients With Mycosis Fungoides Type CTCL (Stage IB-IVB) or Sezary Syndrome Who Are Refractory or Intolerant to Targretin® (Bexarotene) and One Other Standard Therapy


Phase 3
18 Years
N/A
Not Enrolling
Both
Mycosis Fungoides, Sezary Syndrome

Thank you

Trial Information

Open Label, Dose Escalation, Followed by Open Label,Single Arm Clinical Trial of HuMax-CD4 in Patients With Mycosis Fungoides Type CTCL (Stage IB-IVB) or Sezary Syndrome Who Are Refractory or Intolerant to Targretin® (Bexarotene) and One Other Standard Therapy


Inclusion Criteria:



- A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive
phenotype within 6 months of study entry

- Refractory to or intolerant to at least two prior therapies, one being Targretin® (or
combinations hereof).

- Signed informed consent

Exclusion Criteria:

- Prior treatment with Total Skin Electron Beam (TSEB) therapy within six months

- Prior treatment with Campath (alemtuzumab)

- Prior treatment with more than three regimens of single agent chemotherapy

- Prior treatment with pentostatin within 6 months

- 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 glucocorticosteroids , carmustine, nitrogen mustard,
systemic vitamin A or etretinate

- Treatment with topical glucocorticosteroids within 2 weeks prior to visit 2

- 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

- 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

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

- Known or suspected positive serology for HIV

- Known or suspected positive serology for hepatitis B or C

- 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)

- Prior treatment with anti-CD4 monoclonal antibodies

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

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PGA Score

Outcome Time Frame:

Duration of Study

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

Hx-CD4-110

NCT ID:

NCT00127881

Start Date:

July 2005

Completion Date:

Related Keywords:

  • Mycosis Fungoides
  • Sezary Syndrome
  • Refractory or intolerant to Mycosis Fungoides and sezary syndrome
  • Cutaneous T-cell Lymphoma
  • To evaluate the efficacy and safety of zanolimumab in Mycosis Fungoides and sezary syndrome
  • Mycoses
  • Mycosis Fungoides
  • Sezary Syndrome

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Stanford University Medical CenterStanford, California  94305-5408
Boston Medical CenterBoston, Massachusetts  02118
University of ColoradoDenver, Colorado  80217
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Oregon Health & Science UniversityPortland, Oregon  97201
Duke University Medical CenterDurham, North Carolina  27710
University of Michigan Medical CenterAnn Arbor, Michigan  48104-0914
Northwestern UniversityChicago, Illinois  60611
SUNY Upstate Medical UniversitySyracuse, New York  13210
H. Lee Moffitt Cancer CenterTampa, Florida  33612
Ohio State UniversityColumbus, Ohio  43210
The Emory ClinicAtlanta, Georgia  30322
Memorial Sloan KetteringNew York, New York  10021
Tulane University Health Science CenterNew Orleans, Louisiana  70112
New York Medical CenterNew York, New York  10016
University Hospital of ClevelandCleveland, Ohio  44106
University of Pennsylvania Health SystemPhiladelphia, Pennsylvania  19104
Middle Tennessee Research InstituteNashville, Tennessee  37212-2637