High Dose Ascorbate With Preoperative Radiation in Patients With Locally Advanced Soft Tissue Sar… (NCT03508726) | Clinical Trial Compass
CompletedPhase 1/2
High Dose Ascorbate With Preoperative Radiation in Patients With Locally Advanced Soft Tissue Sarcomas
United States25 participantsStarted 2019-06-27
Plain-language summary
This is a single-arm open-label phase Ib/II clinical study assessing the efficacy of concurrent high dose ascorbate in combination with radiotherapy in patients with locally advanced, resectable, high grade sarcomas.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject or subject's legally acceptable representative has provided informed consent.
✓. Histologically confirmed diagnosis of locally advanced soft tissue sarcoma of extremity, trunk or retroperitoneum that is unresectable with clear wide margins, for which preoperative radiotherapy is considered appropriate
✓. Patients with locally recurrent sarcoma after surgery alone are eligible for enrollment if other inclusion criteria are met.
✓. Patients do not have histologic subtypes: GIST, Desmoid, Ewing sarcoma, bone sarcomas and Kaposi sarcoma.
✓. Age ≥18 years.
✓. Patients with a history of non-melanomatous skin cancer, in situ carcinoma, or low-risk prostate cancer can be enrolled.
✓. ECOG performance status \</=1.
✓. Tolerate one test dose (15g) of ascorbate.
Exclusion criteria
✕. Inadequate organ function within 21 days of Day 1 of study as defined by:
✕. Prior history of symptomatic oxalate kidney stones within the last year.
✕. Prior radiation therapy in excess of 20 Gy to the site of the current diagnosis of sarcoma. No overlap with prior radiation fields in excess of 20 Gy is allowed.
What they're measuring
1
Number of Participants That Experienced Dose Limiting Toxicities (DLTs) Using CTCAE, Version 4.0
Timeframe: Start of treatment up to 4 weeks after the last ascorbate infusion
2
Number of Participants With Pathologic Tumor Necrosis ≥ 95% Following Concurrent Radiation Therapy and Ascorbate
Timeframe: Start of treatment up to 6 weeks after the last ascorbate infusion
✕. Prior history of receiving pharmacological ascorbate.
✕. Patients actively receiving insulin therapy and needing daily fingerstick for glucose monitoring.
✕. Concurrent, clinically significant, active malignancies within two years of study enrollment.
✕. Female subjects who are pregnant or breast-feeding, or planning to become pregnant during study treatment and through 3 months after the last dose of study treatment.