Losartan + Sunitinib in Treatment of Osteosarcoma
ConditionOsteosarcoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age10+
SponsorUniversity of Colorado, Denver
About this trial
This study is a Phase 1/1b clinical trial that aims to determine the Maximally Tolerated Dose of Losartan and Sunitinib Combination Therapy. Patients will first be accrued to the Dose Escalation phase of the study, using a 3+3 design. Medication dosages will increase until a maximally tolerated dose is found. Patients will then be accrued to the Dose Expansion phase of the trial, where efficacy of pre-determined dose will be preliminarily assessed.
Eligibility criteria
Qualifiers
1. Provision to sign and date the consent form (if individual is a minor, provision of a parent or legal guardian to sign and date the consent form and provision of individual to provide assent for study).
Patients with surface or periosteal osteosarcoma are not eligible.
Patients with active CNS metastasis are not eligible. Previously treated CNS metastases which occurred 3 months or more prior, without evidence of active recurrence, are acceptable.
Dose Escalation (Part A): Patients must have measurable or evaluable disease.
Disqualifiers
Peripheral absolute neutrophil count (ANC) ≥ 750/mm3
Platelet count ≥ 75,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).
Creatinine clearance or radioisotope GFR > 70 mL/min/1.73 m2 OR a serum creatinine based on age/gender.
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age
Trial design
Treatments tested in this trial
- Losartan
- Sunitinib
Treatment groups
41 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Colorado, Denver
Lead sponsor
Cancer League of Colorado
Collaborator
Colorado State University
Collaborator
Swim Across America
Collaborator
Source ClinicalTrials.gov