Spots Global Cancer Trial Database for PAZIT Study for Children and Young Adults With Relapsed or Refractory Sarcoma

Study Description

Brief Summary: This is the first study to evaluate the safety and clinical activity of the combination of oral pazopanib, intravenous or oral irinotecan, and oral temozolomide in pediatric and young adult patients with relapsed or refractory sarcomas. This study will use a 3 + 3 design for dose escalation (Part 1), followed by an expansion cohort (Part 2) at the recommended phase 2 dose level.

Detailed Description: The combination of irinotecan and temozolomide is well-tolerated and provides an active therapy option for heavily pre-treated patients with sarcoma. The toxicity profile and activity level suggest that this combination will provide a useful platform onto which novel compounds may be added. Pazopanib has been shown to demonstrate single-agent activity in sarcomas in the preclinical and clinical settings. Pazopanib has also been shown to have additive or synergistic effects in preclinical models of sarcomas when combined with cytotoxic chemotherapy. Pharmacokinetic studies of pazopanib and irinotecan as well as pharmacodynamic studies of pazopanib to assess anti-angiogenesis will be performed. Exploratory studies to assess non-invasive methods of monitoring tumor response \[circulating tumor DNA and functional imaging by positron emission tomography (PET)/magnetic resonance imaging (MRI) will be performed\].

Keywords

Eligibility

Minimum Age: 6 Years

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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