Trial Search Results

Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma

This phase II trial studies how well denosumab works in treating patients with osteosarcoma that has come back (recurrent) or does not respond to treatment (refractory). Monoclonal antibodies, such as denosumab, may block tumor growth in different ways by targeting certain cells.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Children's Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Biological: Denosumab
  • Other: Laboratory Biomarker Analysis
  • Other: Pharmacological Study

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Female patients must have a bone age of equal to or greater than 12 years of age as
   determined by local read of appropriate radiographic imaging

   - Male patients must have a bone age of equal to or greater than 14 years of age as
   determined by local read of appropriate radiographic imaging

   - Patients must have relapsed or become refractory to conventional therapy, with a
   regimen including some combination of high dose methotrexate, doxorubicin, cisplatin,
   ifosfamide and etoposide; and have had histologic verification of osteosarcoma at
   original diagnosis or at the time of recurrence

   - Cohort 1 patients must have measurable disease according to Response Evaluation
   Criteria In Solid Tumors (RECIST) 1.1

      - Note: Patients in Cohort 1 will be stratified as follows:

         - Stratum 1: Patients >= 11 years of age but < 18 years

         - Stratum 2: Patients >= 11 years of age but < 50 years

   - Cohort 2 patients must have had a complete resection of all sites of metastatic
   disease within 30 days prior to enrollment

      - Patients will only be eligible after they have undergone complete surgical
      resection of suspected metastatic disease that is histopathologically confirmed
      to be osteosarcoma prior to enrollment

         - Note: The definition of complete resections is: gross resection of all
         disease as per the operating surgeon; post-operative imaging is not required
         for confirmation of complete resection

      - Patients must undergo resection of any lung lesion meeting criteria for likely
      metastatic disease, defined as:

         - 3 or more lesions > 5 mm in diameter OR a single lesion > 1 cm

      - Patients with lung as the only site of resected metastatic disease must have
      refused participation in protocol AOST1421

   - Patient must have adequate tumor specimen available for submission

   - Patients must have a performance status corresponding to Eastern Cooperative Oncology
   Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and
   Lansky for patients =< 16 years of age

   - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
   mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:

      - Age: 11 to < 13 years old; 1.2 (male, female) maximum serum creatinine (mg/dL)

      - Age: 13 to < 16 years old; 1.5 (male), 1.4 (female) maximum serum creatinine
      (mg/dL)

      - Age: >= 16 years old; 1.7 (male), 1.4 (female) maximum serum creatinine (mg/dL)

   - Total bilirubin =< 1.5 x upper limit of normal (ULN) for age

   - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
   serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x
   ULN for age

   - Serum calcium or albumin-adjusted serum calcium >= 2.0 mmol/L (8.0 mg/dL) and =< 2.9
   mmol/L (11.5 mg/dL)

   - All patients and/or their parents or legal guardians must sign a written informed
   consent

   - All institutional, Food and Drug Administration (FDA), and National Cancer Institute
   (NCI) requirements for human studies must be met

Exclusion Criteria:

   - Patients with known sensitivity to any of the products to be administered during the
   study (eg, mammalian derived products, calcium or vitamin D)

   - Patients who are receiving other cancer directed therapy at the time of enrollment

   - Patients who have previously received denosumab

   - Patients who have previously received mithramycin, strontium-89, samarium-153 or
   rhenium

   - Patients receiving bisphosphonates

   - Pre-existing conditions

      - Disorders associated with abnormal bone metabolism

      - Hypocalcemia that is not corrected with oral calcium supplementation

      - Vitamin D < 20 ng/mL

      - Paget's disease

      - Prior history or current evidence of osteonecrosis of the jaw

      - Any dental or oral condition likely to result in disruption of mucosal integrity
      during denosumab therapy including: active dental or jaw condition requiring oral
      surgery or tooth extraction; non-healed dental or oral surgery

      - Unstable systemic disease, excluding osteosarcoma, such as unstable proximal
      renal tubule dysfunction (Fanconi Syndrome) or congestive heart failure

   - Pregnancy and breast feeding

      - Female patients who are pregnant; a pregnancy test is required for female
      patients of childbearing potential

      - Lactating females who plan to breastfeed their infants

      - Sexually active patients of reproductive potential who have not agreed to use an
      effective contraceptive method for the duration of their study participation and
      for 5 months after the end of study treatment

Ages Eligible for Study

11 Years - 49 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting