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Completed
NCT01588522
Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for the Treatment of Chemotherapy-Induced Alopecia
Conditions: Chemotherapy-Induced Alopecia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 28
Sponsor: BPGbio
Location: Samuel Oschin Comprehensive Cancer Institute Cedars-Sinai Los Angeles California
Summary
The goal of this clinical trial is to learn if Compound 31543 (topical calcitriol) for treatment of hair-loss in patients with a diagnosis of breast cancer, gynecologic cancer or sarcomas receiving a taxane-based chemotherapy is safe. The main questions it aims to answer are:
* What medical problems do participants have when using compound 31543?
* How much Compound 31543 is in blood after treatment?
* How much hair is lost during treatment?
Participants will:
* Apply Compound 31543 to their scalp twice a day, starting at least 5 days before starting chemotherapy for at least 3 months or until chemotherapy treatment is completed.
* Have blood drawn on weeks 1, 5, 9, 13, and 54.
* Have photographs taken of their hair before starting and at weeks 7, 15, 27, and 54.
* Keep a diary of the condition of their hair.
Eligibility Criteria
Inclusion Criteria:
* Adult patients at least 18 years of age
* Able to fully understand and participate in the informed consent process
* Patients who are scheduled to receive a taxane-based regimen for a histologically confirmed solid tumor that is:
1. Early stage and/or treatment naïve, or
2. Relapsed or is refractory to previous therapy, or
3. Operable and necessitates adjuvant or neo-adjuvant treatment
* Have no evidence of alopecia or mild alopecia (NCI CTCAE v.4.0 grade 1 alopecia defined as hair loss of \ 1500 cells/mm3 within 72 hours prior to registration
* Has serum calcium less than or equal to upper limit of normal (ULN) (for patients with an albumin lower than 3.0, a corrected calcium serum calcium = serum calcium +\[0.8\]\[3.5-serum albumin\]) within 72 hours prior to registration
Exclusion Criteria:
* Patients receiving calcium-lowering therapy or drugs that may affect calcium levels (e.g., calcitonin, mithramycin, phosphate, denosumab) within 4 weeks of initiation of topical calcitriol. Patients who have been managed with bisphosphonates or calcium-lowering therapy for 3 months or greater prior to the start of the trial and have demonstrated evidence for stability of calcium metabolism would be considered eligible for participation in the trial.
* Has a history of drug or alcohol abuse within 1 year of study enrollment as determined by the investigator.
* Patients who elect to shave the scalp hair prior to the initiation of chemotherapy or who plan to do so during the chemotherapy treatment.
* Any dermatological condition that in the opinion of the investigator will affect the absorption of the study medication, e.g. Atopic Dermatitis, etc.
* Has been treated with an investigational agent within 30 days or six half-lives of its biologic activity whichever is longer, before the start of study. (Patients may not be concurrently enrolled on another trial or concurrently treated with another investigational agent)
* Patients with a history of hypercalcemia or vitamin D toxicity, or hospitalization for treatment of angina, myocardial infarction, or congestive heart failure or psychiatric illness currently or within 30 days of study entry as determined by the investigator.
* Has a history of significant allergy to calcitriol as determined by the investigator.
* Has any condition that interferes with the ability of the subject to understand or comply with the requirements of the study.
* Patients taking Vitamin D supplements during the study, unless they have been taking Vitamin D supplements for 30 days or more prior to the start of the study and that the dose of the Vitamin D supplement remain the same throughout the study.
* Patients treated with medications that are known to affect calcium levels within 4 weeks of initiation of topical therapy (\>500 IU vitamin A, calcium supplements, fluoride, antiepileptics).with the exception of patients on stable therapy for more than six months
* Patients with hypercalcemia or kidney stones
* Patients that indicate they have significant hair breakage or hair damage and associated hair loss from hair over-processing within the last 30 days due to peroxide applications, permanent hair coloring, bleaches, streaking, perms, relaxers and/or hair oxidative dyes.
* Current alopecia grade 2 or greater as per NCI-CTCAE v.4.0, or significant hair loss or hair breakage
* Prior radiation to the cranium
* Pregnant or breastfeeding
Source: ClinicalTrials.gov (NCT01588522). StuddyBuddy aggregates publicly available trial information.