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A Pilot Open-Label Single-Dose Study Using Intravenous Micellar Paclitaxel for Patients With Severe Psoriasis


Phase 2
N/A
N/A
Not Enrolling
Both
Psoriasis

Thank you

Trial Information

A Pilot Open-Label Single-Dose Study Using Intravenous Micellar Paclitaxel for Patients With Severe Psoriasis


Paclitaxel is an antiangiogenic chemotherapeutic drug approved by the FDA for use in cancer.
There is anecdotal evidence that some patients with cancer and concomitant psoriasis have
shown improvement in their skin while receiving paclitaxel for cancer. Angiotech
Pharmaceutical, Inc., the company with commercial rights over non-cancer uses of paclitaxel,
has data that suggests paclitaxel demonstrates anti-inflammatory and immunomodulatory
properties, in addition to the better known antiangiogenic and antiproliferative effects
attributed to this compound. In this pilot open-label single-dose study, we initially
treated patients with severe refractory psoriasis using intravenous Micellar Paclitaxel (75
mg/m(2) every 4 weeks) for six months. Because this dosing regimen was well tolerated and
because the dosing interval seemed too long, we now propose to treat patients with
intravenous Micellar Paclitaxel at the adjusted dose of 37.5 mg/m(2) every 2 weeks.

Inclusion Criteria


INCLUSION CRITERIA:

Ability to provide informed consent to all aspects of the study after full information is
provided.

Age equal or greater than 18 years, but not greater than 70 years old.

Severe psoriasis of at least 6 months duration as defined by the following criteria:
Classic psoriatic skin lesions with or without nail involvement; PASI score greater than
or equal to 20.

Therapeutic failure or inability to tolerate at least two alternative therapies for severe
psoriasis (e.g., methotrexate, acitretin, cyclosporine A, PUVA, UVB, interleukin-10).

Ability to obtain intravenous access.

Negative urine pregnancy test (if female), and if pre-menopausal and sexually active,
using two effective forms of contraception (one form being a barrier method).

WBC count greater than 5,000/mm(3).

Neutrophils greater than 2,500/mm(3).

Platelets greater than or equal to 125,000/mm(3).

Hemoglobin greater than or equal to 10 mg/dL.

Creatinine less than or equal to 1.4 mg/dL.

AST and ALT less than 2 times upper limits of normal.

Normal EKG (if any abnormalities suggestive of coronary artery disease then a normal
stress thallium test will be required for entry).

EXCLUSION CRITERIA:

Use of topical or systemic medications for psoriasis (except for bland emollients) during
2 weeks prior to study entry.

Pregnant or nursing women.

Current drug or alcohol abuse.

Evidence of HIV exposure or of chronic/active hepatitis.

Persons who are allergic to bee stings.

History of anaphylactic reactions.

Prior or concurrent malignancies, except non-melanoma skin cancer or carcinoma in situ of
the cervix that have been adequately treated.

Any clinically significant past or current history of coronary artery disease.

Any confounding past or present medical illness that in the judgement of the investigators
would pose added risk for study participants.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

000211

NCT ID:

NCT00006276

Start Date:

September 2000

Completion Date:

October 2002

Related Keywords:

  • Psoriasis
  • Angiogenesis Inhibition
  • Skin Disease
  • Blood Vessels
  • Cytokines
  • Autoimmune Disease
  • Psoriasis

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892