Spots Global Cancer Trial Database for Gemcitabine Plus Ascorbate for Sarcoma in Adults (Pilot)

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Trial Identification

Brief Title: Gemcitabine Plus Ascorbate for Sarcoma in Adults (Pilot)

Official Title: A Pilot Study of Gemcitabine Plus High-Dose Ascorbate in Locally Advanced Unresectable or Metastatic Soft Tissue and Bone Sarcomas in Adults

Study ID: NCT04634227

Conditions

Sarcoma

Soft Tissue Sarcoma

Unresectable Soft Tissue Sarcoma

Metastatic Bone Tumor

Bone Sarcoma

Interventions

Ascorbate

Study Description

Brief Summary: This study will enroll patients who have a diagnosis of locally advanced, unresectable or metastatic soft tissue or bone sarcoma (except gastrointestinal stromal tumors and Kaposi's sarcoma) from any site.

Detailed Description: The primary objectives of this pilot study are to assess the feasibility of pharmacokinetically-guided, patient-individualized dosing and to obtain preliminary evidence of anti-tumor activity of intravenous ascorbate in combination with gemcitabine to inform a subsequent Phase II trial. Soft tissue and bone sarcomas will be studied as different cohorts given the differences in biology and historical responses to single agent gemcitabine in these disease types. As such, 10 evaluable patients per disease cohort will be included.