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

NCT00978471 | Completed Phase 2 DMC

• 2 other identifiers: OSII-TTP2009-009899-12
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 23

Brief 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.

Conditions

Osteosarcoma

Keywords

Conventional chemotherapy; cytapheresis; Peripheral stem cell autograft; Surgical resection; Thiotepa

Outcome Measures

Primary Outcomes (1)

• Estimate the overall survival rate

  24 months

Secondary Outcomes (6)

• Estimate overall survival after relapse diagnosis

  24 months

• Estimate the survival free progression after randomization

  24 months

• Evaluate the tolerance profile of experimental treatment (hematologic toxicity)

  every 3 weeks

• Estimate the rate of tumor response to treatment as assessed by conventional CT-scan

  at inclusion, day 14-day 21 after the 2nd chemotherapy cycle, before randomization, day 14-day 21 after the 4th chemotherapy cycle, after thiotepa cure and 8 weeks after the end of treatment

• Estimate histological response to treatment on surgical tumor samples

  If surgery is applicable, a few weeks after thiotepa cure (12 to 17 weeks after inclusion)

Study Arms (2)

experimental arm thiotepa

EXPERIMENTAL

4 courses of conventional chemotherapy followed by high-dose Thiotepa with peripheral stem cell rescue. Surgical resection of all tumor masses will be performed as soon as possible.

Drug: Thiotepa

Reference arm

OTHER

4 courses of conventional chemotherapy. Surgical resection of all tumor masses will be performed as soon as possible.

Drug: Thiotepa

Interventions

Thiotepa DRUG

Thiotepa 8-12mg/m²/day/injection Total dose for one cure:15-50mg.

Also known as: N N'N'triethylenethiophosphosphoramide, Tepadina

Reference arm; experimental arm thiotepa

Eligibility Criteria

• Age: 1 Year - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (23)

CHU Besançon- Hôpital Jean Minjoz

Besançon, 25000, France

Location

Chu - Hopital Des Enfants Bordeaux

Bordeaux, 33000, France

Location

CHU Dijon Le Bocage, Hôpital d'Enfants

Dijon, 21079, France

Location

Chu Grenoble

Grenoble, 38045, France

Location

Centre Oscar Lambret

Lille, 59000, France

Location

Centre Léon Bérard - Institut d'Hémato-Oncologie Pediatrique

Lyon, 69373, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

Hôpital des Enfants de la Timone

Marseille, 13385, France

Location

Chu Nantes - Hopital Meres Et Enfants

Nantes, 44093, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

CHU Nice, Hôpital L'Archet 2

Nice, 06202, France

Location

Institut Curie

Paris, 75248, France

Location

Hopital D'Enfants Armand Trousseau

Paris, 75571, France

Location

CHU Poitiers, site de la Milétrie

Poitiers, 86021, France

Location

CHU RENNES - Hôpital Sud

Rennes, 35023, France

Location

Chu La Reunion

Saint-Denis, 97405, France

Location

Institut de Cancérologie de l'Ouest - René Gauducheau

Saint-Herblain, 44805, France

Location

CHU de SAINT-ETIENNE, Hôpital Nord

Saint-Priest-en-Jarez, 42270, France

Location

Institut Lucien Neurwith

Saint-Priest-en-Jarez, 42270, France

Location

Hopital de Hautepierre

Strasbourg, 67098, France

Location

Chu Toulouse - Hopital D'Enfants

Toulouse, 31059, France

Location

Chu Nancy - Hopital D'Enfants

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, 95805, France

Location

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MeSH Terms

Conditions

Osteosarcoma

Interventions

Thiotepa

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Phosphoramides; Organophosphorus Compounds; Organic Chemicals; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Perrine MAREC-BÉRARD, Dr

  Institut d'Hématologie et d'Oncologie Pédiatrique (IHOP) - CLB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 17, 2009
• Study Start: July 1, 2009
• Primary Completion: October 29, 2018
• Study Completion: October 29, 2018
• Last Updated: May 17, 2019

Record last verified: 2018-08

Locations

FR (23)