Adjuvant High-Dose Thiotepa and Stem Cell Rescue Associated With Conventional Chemotherapy in Relapsed Osteosarcoma

• Status: Completed
• Trial end date: 2018-10-29
• Target enrollment: 0
• Participant gender: All

Summary

Approximately 150 new cases of osteosarcoma are reported each year in France, of which 15 to 20% are metastatic.

Further to the initial standard care, about 45% of the patients relapse within a median duration of 20 months.

Result of the OS94 study results and of the investigation performed within the CRLCC, indicate that 25 to 30 patients (children and adults) experience an osteosarcoma relapse each year in FRANCE.

According to several studies, the 5-year overall survival rate of patients in first relapse is 23-28%,with a median post relapse survival of 10 to 17 months. Multiple relapse cases are also reported in the COSS study, with a median time to second relapse of 0.8 year.

At present, there is no reference treatment for the standard care of osteosarcoma relapse in FRANCE.

Thiotepa is known for its antitumor effect in numerous malignant tumors. In 2007, a study from our institution reported that about 35% of all osteosarcoma relapses are treated with a high-dose thiotepa while the efficacy and tolerance of this therapeutic strategy have never been assessed.

These results highlight the need to the evaluate the efficacy and tolerance of this high-dose of thiotepa within a clinical trial and its inclusion in the standard care of the osteosarcoma at relapse.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Leon Berard
• Treatments: Thiotepa

Criteria

Inclusion Criteria:

• Age > 1 year and < 50 years

• First osteosarcoma relapse, either local or metastatic, or second relapse after exclusive surgery NB: Whenever possible, only patients with histological evidence of relapse will be included.

• Indication for chemotherapy confirmed by a multidisciplinary committee.

• Surgical resection of all tumor sites must be possible, either as first-line therapy or after chemotherapy.

• Lansky score ≥ 60%, or ECOG Performance Status ≤ 2

• ≥ 21-day interval after first-line chemotherapy

• Blood tests, renal and liver functions within the normal range for age with, in particular, 7 days prior to study entry, blood or serum values as follows:

• blood: neutrophil count > 1 G/L; platelets >100 G/L

• renal: serum creatinine ≤ 1.5 x ULN depending on age; patients with serum creatinine values > 1.5 x ULN are eligible if creatinine clearance is > 70 mL/min/1.73 m²

• liver: total bilirubin < 2 x ULN; ASAT and ALAT ≤ 5 x ULN

• cardiac: isotopic or echographic Left Ventricular Ejection Fraction > 50 %.

• Signed written informed consent; for children, signed consent from the patient (depending on age) and from the parents or legal representative is mandatory

• Documented negative serum βHCG for female patients of childbearing age

• Affiliation with health insurance.

Exclusion Criteria:

• Patients with multiple relapses for whom surgical resection seems impossible, even after chemotherapy.

• Patients already treated with high-dose chemotherapy regimens

• Patients with a contra-indication to the treatment proposed

• Patients not eligible for leukapheresis

• Two-year follow-up impossible due to social, family, geographic or psychological reasons

• Patient included in another protocol of clinical research

• Pregnant or lactating women.