A Study to Determine the Activity of SCH 717454 in Subjects With Osteosarcoma or Ewing’s Sarcoma That Has Relapsed After Standard Systemic Therapy.

Not Applicable

Conditions: -C40 Malignant neoplasm of bone and articular cartilage of limbs-C41 Malignant neoplasm of bone and articular cartilage of other and unspecified sites
Malignant neoplasm of bone and articular cartilage of limbs
Malignant neoplasm of bone and articular cartilage of other and unspecified sites
C40
C41

Registration Number: PER-034-08

Lead Sponsor: SCHERING PLOUGH RESEARCH INSTITUTE,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 3

Inclusion Criteria

• Subjects over 11 years of age, of any sex and race;
• Subjects diagnosed with osteosarcoma or histologically confirmed Ewing´s sarcoma;
• Subjects with: a. recurrent and resectable osteosarcoma (to be included in Group 1) that: has relapsed after usual treatment (ie, before exposure to a cisplatin / doxormbicin regimen and a regimen containing ifosfamide); and must present the recurrence confirmed within 6 months after the immediate previous treatment of osteosarcoma (in the case of having elapsed a longer period, you should consult with the sponsor); and must have a tumor sample, surgical or obtained by biopsy puncture with a thick needle (to determine historical tumor proliferation), and the subject must not have been receiving treatment directed to the tumor at the time of obtaining the sample or there must be presented progression of the disease while in said treatment. The sample must have been obtained within 8 months prior to entering the study (cases of samples obtained> 8 months before entering the study should be consulted with the sponsor). b. Recurrent and unresectable osteosarcoma (to be included in Group 2) refractory to usual treatment, that is, it has relapsed after previous systemic treatment with active chemotherapeutic agents (ie, prior exposure to cisplatin / doxorubicin and a regimen containing ifosfamide). The subject must have measurable disease in a computed tomography or magnetic resonance performed during the Selection (within 21 days of Day 1); c. Ewing´s sarcoma (to be included in Group 3) refractory to usual systemic treatments (ie, ifosfamide / etoposide, and cyclophosphamide, doxorubicin, and vincristine). The subject must have measurable disease in a computed tomography or magnetic resonance performed during the Selection (within 21 days of Day 1);
• Subjects> 16 years of age must have a general status of 2 on the scale of the Eastern Cooperative Oncology Group (ECOG); 6-year-old subjects must have a general state on the Karnofsky scale between 50% and 100% or a score between 50% and 100% on the Lansky game execution scale;
• Subjects must have a minimum life expectancy of> 4 months;
• The subjects must have an adequate organic function within 3 weeks prior to Day 1, evidenced by: a. hemoglobin> 9 g / dL, (> 8 g / dL in subjects with Ewing´s sarcoma), b. absolute neturophil count> 1.5 x 10® / L, (> 1.0 x 10 ^ / L in subjects with Ewing´s sarcoma), c. platelet count> 100 x 10® / L, (^ 50 x 10 ^ / L in subjects with Ewing´s sarcoma), d. creatinine <1.5 times the upper limit of normal (ULN) or creatinine clearance> 60 mL / min, e. total bilirubin <1.5 x ULN, except in the case of subjects with Gilbert´s disease, f. aspartate aminotransferase (ASI) / serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) / serum glutamic-pyruvic transaminase (SGPT) <3 times the upper limit of normal, or in the presence of confirmed liver metastases <5 times the upper limit of normal. Laboratory values that are out of range in the Selection may be repeated once during the Selection Period.
• The subjects (and / or their parent / guardian in the case of subjects under the legal age necessary to grant a valid consent) must give their informed consent in writing and be able to comply with the dose and visit schedules;
• Women of childbearing age who participate as study subjects and those who are in pairs with a study subject must agree to u

Exclusion Criteria

• Subjects with a history of another malignancy (with the exception of non-melanoma skin cancer or carcinoma in situ of the cervix treated with curative intention for at least 2 years before the start of treatment, or another malignancy adequately treated of which the subject has been free for 5 years);
• Subjects with confirmed leptomeningeal metastases treated or untreated, or with a metaplastic lesion of the central nervous system.
• Subjects with a history of uncontrolled diabetes mellitus, defined as hemoglobin A1C of 57.5% in a patient with confirmed diabetes mellitus.
• Subjects with recent myocardial infarction (within the last year), or subjects who present unstable or uncontrolled angina at the time of selection, congestive heart failure Class III or IV of the New York City Cardiology Association (NYHA), uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant alterations in the electrocardiogram (ECG);
• Subjects with active infection.
• Subjects with clinically significant hepatitis in the Selection, or subjects with a positive result of antibodies for hepatitis C, positive results of the surface antigen of hepatitis B, or seropositive for the immunodeficiency virus (HIV).
• Subjects who have been treated with an antibody or drug specifically directed against IGF-1R.
• Subjects with hypersensitivity to other antibodies, or to any of the excipients that accompany these medications;
• Subjects with unresolved toxicity related to the drug 5 Grade 2 according to the common terminology criteria for adverse events (CTCAE), associated with previous treatment (the inclusion of subjects with persistent neuropathy or hearing loss> Grade 2 due to previous treatment you must talk to the sponsor);
• Subjects with any situation or clinically significant condition, other than the one being studied that, in the opinion of the researcher, would interfere with the study´s evaluations or the optimal participation in the study.
• Subjects who have received any of the treatments listed in Table 3 of Section 7.3.2 within a period prior to the Selection more recent than indicated or who must continue receiving any treatment listed in Table 3 of Section 7.3 .two.
• Women who are breastfeeding, pregnant or expect to become pregnant, or whose pregnancy test result is positive.
• Subjects who are participating in another clinical trial with a potentially therapeutic agent or who have received another investigational product within 21 days prior to Day 1;
• Subjects with little probability of completing the study and the corresponding follow-up visits

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:The tumor proliferation response will be estimated as a 25% decrease in the proliferation of tumor cells after exposure to SCH 717454 compared to the intraindividual historical sample.<br>Measure:rate of tumor proliferation compared with historical tumor proliferation<br>Timepoints:After treatment<br>;<br>Outcome name:evaluated by the RECIST and WHO criteria.<br>Measure:tumor response rate<br>Timepoints:After treatment<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Clinical evaluation and laboratory tests<br>Measure:time to progression<br>Timepoints:During the study<br>;<br>Outcome name:• Appearance of adverse events,<br>• ECG parameters,<br>• Safety laboratory tests, and<br>• Vital signs.<br>• CD4 assessments.<br>Measure:Safety<br>Timepoints:During the study<br>

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