Giant Cell Tumors of Bone Clinical Trial
— ZometaOfficial title:
Phase 2 Study of the Effect of Zoledronate on Local Recurrence After Surgical Treatment of Giant Cell Tumors of Bone
The giant cell tumor (GTC) is an aggressive benign bone tumor, growing at the
metaphyseal-epiphyseal regions of long bones, especially around the knee and the distal
radius.It is responsible for bony destruction in para-articular zone fracture and leading to
the breakdown and destruction of the underlying joint.
Histologically, the tumor cell contains a contingent of monocytic cells round, a contingent
of giant type cell of type osteoclastic responsible for bone resorption that accompanies
these tumors and a contingent of lengthened cells fibroblast-like considered to be
contingent tumor.
The treatment is exclusively surgical; or by resection of the lesion which takes away tumour
and its environment, solution which, if it prevents local recurrence, imposes an important
bony and articular reconstruction, always limited and deteriorating rapidly over time in
these young patients; or by curettage of lesion, by "hollowing-out" of the bone, creating a
hole which it will be necessary to fill up by a bony grafting or a substitute of the bone
(cement). This last solution, if it preserves a better function, exposes at risk of local
recurrence,putting into play the prognosis of articulation near, most often the knee.Despite
different local adjuvants treatments used during surgical operation, after having curetted
the cavity and before filling it up, the recidivism rates vary from 12 % to 41 % (average 25
%) in literature.
The beneficial effect of the adjuvants therapeutics suggests the concept broadly accepted by
a tumoral microscopic residual at the origin of the local recidivism .Biphosphonates (BP) is
molecules which settle in vivo on the hydroxyapatite of the bone; they inhibit the
recruitment of the osteoclast forerunners and the activity of mature osteoclast. Besides,
biphosphonates containing some nitrogen (N-BP), leads to the apoptose of mature osteoclast.
These molecules also have a direct effect on tumor cells , causing apoptosis of neoplastic
cells of myeloma, of breast cancer. Clinical controlled studies confirm the experimental
data of N-BP. Two work also showed their effect on osteoclasts and stroma cells of tumours
with giant cells but no clinical study assessed potential on the prevention of the local
recurrence.
The investigators offer a study phase 2 of the effectiveness of N-BP (acid zoledronique) on
the prevention of the local recurrence of tumours with primary huge cells after surgical
treatment by curettage - filing by a surgeon referent in oncologic orthopedic surgery.
Number of patients: 24
| Status | Terminated |
| Enrollment | 24 |
| Est. completion date | January 2011 |
| Est. primary completion date | January 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patient age (18 years) - Benign giant cell tumor of the bone histologically confirmed after biopsy - Non-metastatic tumor - The first surgical treatment of the tumor - Indication of conservative treatment with curettage, filling asked by the surgeon investigator - Written consent of the patient Exclusion Criteria: - Minor patient - Location of a pulmonary TCG - Surgical indication of prior or immediately en bloc resection - Need for treatment with an aminoglycoside - Against-indication for zoledronic acid: pregnancy, lactation, known hypersensitivity to this drug or another bisphosphonate, severe renal impairment or a previous kidney failure, severe bradycardia or conduction disturbance on ECG. - Dental Problems in progress, including an infection of the teeth or jaw underlying (mandible and maxilla), dental trauma or recent diagnosis or history of osteo-necrosis of the jaw (ONJ) , or exposure of the OSE or delayed healing after dental procedures. - Dental or jaw bone recent (within 6 weeks) or planned (extractions, implants, ...). |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Nantes | Nantes |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Decrease in the recurrence rate of GTC of the bone after surgery (efficacy). | 36 months | Yes | |
| Secondary | Tolerance at the filling treatment with zoledronic acid (safety). | Clinical examination of the patient, clinical examination (confusing yes / no, headache yes / no, visual yes / no, nausea yes / no, vomiting yes / no, itching rash yes / no, arthralgia yes / no, bone pain yes / no, bradycardia <60 during the infusion yes / no, fever yes / no, taste thirst yes / no, chest pain yes / no) Organic: blood count (NFS), creatinine, serum calcium, phosphate, magnesium (below the standards of the laboratory that conducted the review yes / no) |
36 months | Yes |