Safety and Tolerability of I-040302 in Children and Young Adults With Solitary Bone Cysts

NCT ID: NCT00459641

Last Updated: 2012-07-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2019-07-31

Brief Summary

This is a randomised, controlled, open-label study of a single intralesional administration of I-040302 or a single bone marrow aspirate or a single steroid injection (methylprednisolone). Subjects will undergo screening with X-ray and magnetic resonance imaging (MRI) in the diagnosis of a solitary bone cyst.

Conditions

Bone Cysts

Keywords

Osteogenic Gel; Solitary Bone Cysts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

I-040302 doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34

Group Type: EXPERIMENTAL

I-040302

Intervention Type: DRUG

doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34

2

Standard of care (bone marrow aspirate or steroids)

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Bone marrow aspirate or steroids

Interventions

I-040302

doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34

Intervention Type: DRUG

Standard of Care

Bone marrow aspirate or steroids

Intervention Type: OTHER

Other Intervention Names

Bone marrow aspirate or steroids

Eligibility Criteria

Inclusion Criteria

1. Subjects 6 - 16 years of age

2. Diagnostic evidence of unicameral bone cysts based on one or more of a combination of any of the following methods:

• Cyst fluid examination
• Plain radiographs
• MRI

3. Subjects with the following types of cysts:

• Intact cysts that are either growing or at risk of fracture, requiring surgical intervention
• Persistence of a cyst cavity following cyst fracture that has received conservative treatment/s to repair the fracture
• Persistence of a cyst cavity despite repeated interventions

4. Subjects with bone cyst volumes < 30 mL

5. Subjects must be appropriately communicative to verbalise pain.

6. Subjects must be able to understand and be willing to comply with the protocol procedures.

7. Subjects who have provided written informed consent to participate in the study

8. The legally authorised representative of the child must give written informed consent after the child has agreed to participate in the study.

Exclusion Criteria

1. A history of/or presence of active cancer

2. Family history of retinoblastoma

3. Indication of aneurysmal bone cyst on MRI, cyst aspiration or histology

4. Possible presence of osteosarcoma or uncertain histology

5. Systemic or localised infection at time of surgery

6. Evidence of immune-suppression

7. Evidence of hypercalcemia

8. Cyst volume > 30 mL

9. Fracture present in the cortical bone surrounding the cyst

10. Evidence of rapid venous drainage from the cyst determined by rapid disappearance of X-ray contrast medium during the surgical process.

11. Suspected or known evidence of allergic reactions towards any of the components of I-040302

12. Known clinically significant organ or systemic diseases such that, in the opinion of the investigator, the significance of the disease will compromise the subject's participation in the study

13. Pregnant or lactating females

14. Participation in another clinical trial within 3 months prior to trial start

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kuros Biosurgery AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Virginia Jamieson, MD

Role: STUDY_DIRECTOR

Kuros Biosurgery AG, Technoparkstrasse 1, CH-8005 Zurich

Countries

Italy; Switzerland

Other Identifiers

CS I-040302/01

Identifier Type: -

Identifier Source: org_study_id