PsoriasisPhase 2NCT00006276
Micellar Paclitaxel to Treat Severe Psoriasis
A Phase 2 study testing Micellar Paclitaxel in people with Psoriasis, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study will evaluate the safety and effectiveness of micellar paclitaxel for treating severe psoriasis. Paclitaxel in another formulation (Taxol) is approved by the Food and Drug Administration for use in patients with cancer. This drug can decrease growth of cancer cells and of new blood vessels. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psoriasis
- What is being tested?
- Micellar Paclitaxel
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to Oct 2002
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Show all 13Show fewer
- 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).
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Official title: A Pilot Open-Label Single-Dose Study Using Intravenous Micellar Paclitaxel for Patients With Severe Psoriasis
This study will evaluate the safety and effectiveness of micellar paclitaxel for treating severe psoriasis. Paclitaxel in another formulation (Taxol) is approved by the Food and Drug Administration for use in patients with cancer. This drug can decrease growth of cancer cells and of new blood vessels. Because patients with psoriasis have an increase in skin cell and blood vessel growth, paclitaxel may also improve their condition. The dose of drug used in this study is much lower than those used to treat cancer patients and is expected to cause relatively few side effects.
Patients 18 to 70 years of age with psoriasis lesions affecting at least 20% of their skin may be eligible for this study. Candidates will be screened with a history and physical examination, blood and urine tests, electrocardiogram, and possibly an exercise stress test.
Read more
Participants will receive six intravenous (through a vein) infusions of paclitaxel over a 6-month period. Each infusion will take about 2 hours. Patients will stay in the clinic for observation for at least 1 hour before going home and will return to the clinic for follow-up examination and tests one week after each infusion. However, on weeks 0 and 8 visit will last for approximately 8 hours and will require a return to the clinic the following morning. Blood collection will be performed during the week 0 and 8 visits to determine how fast Micellar Paclitaxel is eliminated from your body. Approximately 2 teaspoons of blood will be taken prior to the infusion, twice during the infusion, and eight times during the 22 hours following the infusion for a total of eleven samples. These return visits will last approximately 1-2 hours. Patients will have the following procedures:
- A skin biopsy (removal of a small tissue sample for microscopic examination) will be done at the first visit (week 0) and again at weeks 6, 14 and 22. The area of the biopsy will be numbed with an anesthetic, and a small circle of skin about the width of a pencil eraser and half as deep will be cut and lifted away. Stitches will be placed and removed 1 to 2 weeks later.
- A history and physical examination will be done at every visit. Patients will be interviewed about changes in their skin condition and about treatment side effects and will be examined by a nurse or physician.
- Blood and urine samples will be collected at frequent intervals (nearly every visit) to test for side effects.
- Photographs of the skin will be taken at the first visit and at several later visits to document changes in psoriasis.
- A blood sample will be drawn for genetic testing to look for gene changes in people with psoriasis.
- An electrocardiogram will be taken at the last visit. This will be done at week 24 and compared to the screening EKG.
- Gonadal toxicity monitoring will be started with all patients entered into the protocol as of May 2001. Blood will be drawn to measure Inhibit A for females and Inhibit B for males at weeks 0, 6, 14, and 22.
Read the detailed description
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.
- Conditions
- Psoriasis
- Being tested
- Micellar Paclitaxel
- Keywords
- Angiogenesis Inhibition, Skin Disease, Blood Vessels, Cytokines, Autoimmune Disease
- Medical subject headings
- Psoriasis, Skin Diseases, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micellar PaclitaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2000 (estimated)
- Study startSep 2000
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006276
- Sponsor's protocol ID
- 000211
- Other IDs
- 00-C-0211
- Status last verified
- Oct 2002
- First submitted
- 14 Sep 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Nickoloff BJ. The immunologic and genetic basis of psoriasis. Arch Dermatol. 1999 Sep;135(9):1104-10. doi: 10.1001/archderm.135.9.1104. No abstract available.
PubMed 10490116Koo JY. Current consensus and update on psoriasis therapy: a perspective from the U.S. J Dermatol. 1999 Nov;26(11):723-33. doi: 10.1111/j.1346-8138.1999.tb02083.x.
PubMed 10635614Bos JD, De Rie MA. The pathogenesis of psoriasis: immunological facts and speculations. Immunol Today. 1999 Jan;20(1):40-6. doi: 10.1016/s0167-5699(98)01381-4. No abstract available.
PubMed 10081229
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Open-Label Single-Dose Study Using Intravenous Micellar Paclitaxel for Patients With Severe Psoriasis
- ClinicalTrials.gov ID
- NCT00006276
- Acronym / sponsor ID
- 000211
- Conditions
- Psoriasis
- Keywords
- Angiogenesis Inhibition, Skin Disease, Blood Vessels, Cytokines, Autoimmune Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Sep 2000
- Study completion
- Oct 2002
- First posted
- 15 Sep 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and effectiveness of micellar paclitaxel for treating severe psoriasis. Paclitaxel in another formulation (Taxol) is approved by the Food and Drug Administration for use in patients with cancer. This drug can decrease growth of cancer cells and of new blood vessels. Because patients with psoriasis have an increase in skin cell and blood vessel growth, paclitaxel may also improve their condition. The dose of drug used in this study is much lower than those used to treat cancer patients and is expected to cause relatively few side effects.
Patients 18 to 70 years of age with psoriasis lesions affecting at least 20% of their skin may be eligible for this study. Candidates will be screened with a history and physical examination, blood and urine tests, electrocardiogram, and possibly an exercise stress test.
Participants will receive six intravenous (through a vein) infusions of paclitaxel over a 6-month period. Each infusion will take about 2 hours. Patients will stay in the clinic for observation for at least 1 hour before going home and will return to the clinic for follow-up examination and tests one week after each infusion. However, on weeks 0 and 8 visit will last for approximately 8 hours and will require a return to the clinic the following morning. Blood collection will be performed during the week 0 and 8 visits to determine how fast Micellar Paclitaxel is eliminated from your body. Approximately 2 teaspoons of blood will be taken prior to the infusion, twice during the infusion, and eight times during the 22 hours following the infusion for a total of eleven samples. These return visits will last approximately 1-2 hours. Patients will have the following procedures:
- A skin biopsy (removal of a small tissue sample for microscopic examination) will be done at the first visit (week 0) and again at weeks 6, 14 and 22. The area of the biopsy will be numbed with an anesthetic, and a small circle of skin about the width of a pencil eraser and half as deep will be cut and lifted away. Stitches will be placed and removed 1 to 2 weeks later.
- A history and physical examination will be done at every visit. Patients will be interviewed about changes in their skin condition and about treatment side effects and will be examined by a nurse or physician.
- Blood and urine samples will be collected at frequent intervals (nearly every visit) to test for side effects.
- Photographs of the skin will be taken at the first visit and at several later visits to document changes in psoriasis.
- A blood sample will be drawn for genetic testing to look for gene changes in people with psoriasis.
- An electrocardiogram will be taken at the last visit. This will be done at week 24 and compared to the screening EKG.
- Gonadal toxicity monitoring will be started with all patients entered into the protocol as of May 2001. Blood will be drawn to measure Inhibit A for females and Inhibit B for males at weeks 0, 6, 14, and 22.
Detailed description
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micellar Paclitaxel | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 10490116Nickoloff BJ. The immunologic and genetic basis of psoriasis. Arch Dermatol. 1999 Sep;135(9):1104-10. doi: 10.1001/archderm.135.9.1104. No abstract available.
- Background: PubMed 10635614Koo JY. Current consensus and update on psoriasis therapy: a perspective from the U.S. J Dermatol. 1999 Nov;26(11):723-33. doi: 10.1111/j.1346-8138.1999.tb02083.x.
- Background: PubMed 10081229Bos JD, De Rie MA. The pathogenesis of psoriasis: immunological facts and speculations. Immunol Today. 1999 Jan;20(1):40-6. doi: 10.1016/s0167-5699(98)01381-4. No abstract available.
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Micellar Paclitaxel in people with Psoriasis, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006276, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.