Last reviewed · How we verify
NCT04634227
Gemcitabine Plus Ascorbate for Sarcoma in Adults (Pilot)
Active, enrolled
EARLY_PHASE1
Last updated 4 May 2025
What this trial tests
EARLY_PHASE1 trial testing Ascorbate in Sarcoma in 30 participants. Participants enrolled and being followed up; not accepting new ones.
Timeline
24 November 2020
Primary endpoint
18 March 2025
18 March 2025
31 December 2026
Quick facts
| Lead sponsor | University of Iowa |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 24 November 2020 |
| Primary completion | 18 March 2025 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ascorbate — full drug profile →
Conditions studied
- Sarcoma — all drugs for Sarcoma →
- Soft Tissue Sarcoma — all drugs for Soft Tissue Sarcoma →
- Unresectable Soft Tissue Sarcoma — all drugs for Unresectable Soft Tissue Sarcoma →
- Metastatic Bone Tumor — all drugs for Metastatic Bone Tumor →
Sponsor
University of Iowa
Who can join
18 and older, any sex, with Sarcoma or Soft Tissue Sarcoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
High-dose intravenous vitamin C, a promising multi-targeting agent in the treatment of cancer.
Böttger F, Vallés-Martí A, Cahn L, Jimenez CR. · · 2021 · cited 119× · PMID 34717701 · DOI 10.1186/s13046-021-02134-y -
Iron-Sulfur Cluster Biogenesis as a Critical Target in Cancer.
Petronek MS, Spitz DR, Allen BG. · · 2021 · cited 35× · PMID 34573089 · DOI 10.3390/antiox10091458 -
Molecular mechanisms of osteosarcoma metastasis and possible treatment opportunities.
Du X, Wei H, Zhang B, Wang B, et al · · 2023 · cited 23× · PMID 37197432 · DOI 10.3389/fonc.2023.1117867 -
Navigating the redox landscape: reactive oxygen species in regulation of cell cycle.
Mackova V, Raudenska M, Polanska HH, Jakubek M, et al · · 2024 · cited 19× · PMID 38972297 · DOI 10.1080/13510002.2024.2371173 -
Diverse antitumor effects of ascorbic acid on cancer cells and the tumor microenvironment.
Maekawa T, Miyake T, Tani M, Uemoto S. · · 2022 · cited 16× · PMID 36203466 · DOI 10.3389/fonc.2022.981547
Verify or expand the search:
- PubMed search for NCT04634227
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ascorbate
Trials testing the same drug.
- NCT03541486 — A Clinical Trial Evaluating the Effect of Pharmacological Ascorbate on Radiation Therapy for Pancreatic Cancer Patients · Phase 2 · withdrawn
- NCT06018896 — Vitamin C to Quality of Life in Patients With Terminal Stage Pancreatic Cancer · Phase 2 · recruiting
- NCT06018883 — Vitamin C to Chemotherapy Related Anemia in Pancreatic Cancer · Phase 3 · active not recruiting
- NCT03508726 — High Dose Ascorbate With Preoperative Radiation in Patients With Locally Advanced Soft Tissue Sarcomas · Phase 1, PHASE2 · completed
- NCT03602235 — High Dose Ascorbic Acid for Plasma Cell Disorders · Phase 1 · completed
Other recruiting trials for Sarcoma
Currently open trials in the same condition.
- NCT07402577 — Brief Title Mechanisms of Cancer-Related Pain and Opioid Use Among Adolescents and Young Adult Sarcoma Survivors: Pilot · recruiting
- NCT07501026 — Preoperative Spatially Fractionated Radiation Therapy (SFRT) in Soft Tissue Sarcoma (neoSFRT-SARC) · Phase 2 · recruiting
- NCT07359911 — Effect of A Multimodal Exercise Intervention on Chemotherapy Uptake in Newly Diagnosed Pediatric and AYA Sarcoma Patient · NA · recruiting
- NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07222735 — Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcoma · Phase 1 · recruiting
Other University of Iowa trials
Trials by the same sponsor.
- NCT07224269 — Effect of Terazosin on ATP Levels in People With Amyotrophic Lateral Sclerosis · EARLY_PHASE1 · not yet recruiting
- NCT07244809 — Probing the Role of Mitochondrial Oxidative Stress in Impaired Vascular Function Among Young Adults With Early Life Adve · NA · recruiting
- NCT07097961 — Paediatric Post-TB Pulmonary Rehab Study · NA · recruiting
- NCT06951594 — Robotic-Assisted Versus Manual Electrode Array Insertion · NA · recruiting
- NCT06710119 — Effect of Custom Dynamic Orthoses on Forefoot Loading · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04634227 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Iowa
- Last refreshed: 4 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04634227.
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