|
Use of Isotretinoin for Prevention of Skin Cancer in Patients with Xeroderma Pigmentosum or Nevoid Basal Cell Carcinoma Syndrome Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Use of Isotretinoin for Prevention of Skin Cancer in Patients with Xeroderma Pigmentosum or Nevoid Basal Cell Carcinoma Syndrome conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Use of Isotretinoin for Prevention of Skin Cancer in Patients with Xeroderma Pigmentosum or Nevoid Basal Cell Carcinoma Syndrome Clinical research trials and Use of Isotretinoin for Prevention of Skin Cancer in Patients with Xeroderma Pigmentosum or Nevoid Basal Cell Carcinoma Syndrome healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Use of Isotretinoin for Prevention of Skin Cancer in Patients with Xeroderma Pigmentosum or Nevoid Basal Cell Carcinoma Syndrome. Use of Isotretinoin for Prevention of Skin Cancer in Patients with Xeroderma Pigmentosum or Nevoid Basal Cell Carcinoma Syndrome Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Use of Isotretinoin for Prevention of Skin Cancer in Patients with Xeroderma Pigmentosum or Nevoid Basal Cell Carcinoma Syndrome clinical trial. Subjects frequently obtain the most expert healthcare possible for their Use of Isotretinoin for Prevention of Skin Cancer in Patients with Xeroderma Pigmentosum or Nevoid Basal Cell Carcinoma Syndrome condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "U" Clinical Trials Conditions > Use of Isotretinoin for Prevention of Skin Cancer in Patients with Xeroderma Pigmentosum or Nevoid Basal Cell Carcinoma Syndrome  Use of Isotretinoin for Prevention of Skin Cancer in Patients with Xeroderma Pigmentosum or Nevoid Basal Cell Carcinoma Syndrome
Use of Isotretinoin for Prevention of Skin Cancer in Patients with Xeroderma Pigmentosum or Nevoid Basal Cell Carcinoma Syndrome
For Condition: Xeroderma Pigmentosum,Basal Cell Nevus Syndrome
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: In a prior study (84-C-0039) oral isotretinoin, administered in high dose (2 mg/kg/day), was effective in preventing the appearance of new skin cancers in patients with xeroderma pigmentosum. The incidence of new skin cancers in patients with the nevoid basal cell carcinoma syndrome also improved. Some patients responded to doses as low as 0.5 mg/kg/day. The purpose of this protocol is to continue to follow those patients previously treated and to study new patients to further define the cancer preventative effects of isotretinoin in these genodermatoses.
Details: In a prior study (84-C-0039) oral isotretinoin, administered in high dose (2 mg/kg/day), was effective in preventing the appearance of new skin cancers in patients with xeroderma pigmentosum. The incidence of new skin cancers in patients with the nevoid basal cell carcinoma syndrome also improved. Some patients responded to doses as low as 0.5 mg/kg/day. The purpose of this protocol is to continue to follow those patients previously treated and to study new patients to further define the cancer preventative effects of isotretinoin in these genodermatoses.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Patients with autosomal recessive disorder xeroderma pigmentosum or the autosomal dominant NBCC syndrome: Patients with xeroderma pigmentosum the diagnosis must be documented by the clinical signs and symptoms listed in standard text books: sun sensitivity, increased numbers of freckles and other pigmentary lesions, cutaneous atrophy and telangiectasia, actinic keratoses, and skin cancers. Ocular abnormalities such as photophobia, conjunctivitis, and keratitis or premalignant or malignant tumors of the eye or lids may be present. Some patients may have neurological abnormalities such as progressive hearing loss, diminished reflexes, or progressive mental deterioration. Patients with the nevoid basal cell carcinoma syndrome the diagnosis must be documented on the basis of clinical signs and symptoms listed in standard text books. These include basal carcinomas, palmar pits, skeletal abnormalities, and calcification of the falx. Laboratory tests of ultraviolet inducted killing of cultured cells or of DNA repair may be performed. An accurate assessment of the total number of skin cancers that the patient developed during the past 2 years must be documented by pathology reports. During 2 years prior to beginning oral isotretinoin therapy, the patient must have had a minimum of two documented skin cancers per year. Patients must be clear of all skin cancers before beginning oral therapy. Patients (or parent, guardian, surrogate where appropriate) must give written informed consent. Patients must be available for and agreeable to regular follow-up examinations in the clinic for clinical evaluation and blood tests. Patients must be willing and able to participate for the duration of the study (2 or more years of outpatient treatment). Patients who have not had prior isotretinoin therapy. Patients must obtain appropriate treatment for skin cancers that arise during the study. Fertile women must use effective means of birth control during the time of use of isotretinoin and for 1 month after discontinuing treatment. No evidence of metastatic cancer. Patients with persistently abnormal (SGOT or SGPT greater than 3 times the upper limit of normal) liver function tests are ineligible. Patients with persistent pre-treatment hypertriglyceridemia (greater than 300 mg/dl) are ineligible. Patients with persistently abnormal (creatinine greater than 3 times the upper limit of normal) renal function tests are ineligible. No proven active malignancy other than skin cancer. No severe coronary artery disease (Class III-IV criteria of New York Heart Association). Patients with recent, chronic high dose vitamin A use (greater than 30,000 IU/day) are ineligible. Patients with hypersensitivity to parabens which are in the soft gelatin capsule of Accutane are ineligible.
Total Enrollment: 30
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 910161; 91-C-0161
Study Start Date: June 20, 1991
Record last reviewed: January 11, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005661
Other Basal Cell Nevus Syndrome Studies:
1. Use of Isotretinoin for Prevention of Skin Cancer in Patients with Xeroderma Pigmentosum or Nevoid Basal Cell Carcinoma Syndrome
Related Studies:
Other Basal Cell Nevus Syndrome Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Use of Isotretinoin for Prevention of Skin Cancer in Patients with Xeroderma Pigmentosum or Nevoid Basal Cell Carcinoma Syndrome
|
|
|
|
|
|
|
|
