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NCT01610570 · ClinicalTrials.gov registry record · Phase 1
Mithramycin for Children and Adults With Solid Tumors or Ewing Sarcoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT01610570: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01610570 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01610570, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
Background: \- Mithramycin is a drug that was first tested as a cancer therapy in the 1960s. It acted against some forms of cancer, but was never accepted as a treatment. Research suggests that it may be useful against some solid tumors, particularly Ewing sarcoma. Researchers want to see if mithramycin can be used to treat solid tumors in children and adults. It will be tested in different groups of people, including those with a type of Ewing sarcoma that contains a chemical called Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1). Objectives: \- To see if mithramycin is safe and effective against solid tumors and Ewing sarcoma in children and adults. Eligibility: * Children and young adults between 1 and 17 years of age with solid tumors that have not responded to standard treatment. * Adults at least 18 years of age with EWS-FLI1 Ewing sarcoma that has not responded to standard treatment. * Children and young adults between 1 and 17 years of age with EWS-FLI1 Ewing sarcoma that has not responded to standard treatment. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies and tumor tissue samples will be used to monitor the cancer before treatment. Individuals with solid brain tumors will not be eligible. * Participants will receive mithramycin every day for 7 days, followed by 14 days without treatment. Each 28-day round of treatment is called a cycle. * Treatment will be monitored with frequent blood tests and imaging studies. * Participants will continue to take the drug for as long as the side effects are not severe and the tumor responds to treatment.
Primary Outcome
The MTD will be the maximum dose at which fewer than one-third of patients experience Dose Limiting Toxicity (DLT) (i.e., non-hematologic toxicity and hematologic toxicity) during cycle 1 (or 28 days) of therapy.
Interventions
- DRUG Mithramycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2012-05-10 |
| Est. Completion | 2014-05-21 |
| Phase | Phase 1 |
Why NCT01610570 stopped before completion
NCT01610570 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Mithramycin is the first listed.
NCT01610570 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01610570 about?
NCT01610570 is a clinical study titled "Mithramycin for Children and Adults With Solid Tumors or Ewing Sarcoma". Background: \- Mithramycin is a drug that was first tested as a cancer therapy in the 1960s. It acted against some forms of cancer, but was never accepted as a treatment. Research suggests that it may be useful against some solid tumors, particularly Ewing sarcoma. Researchers want to see if mithra...
What is the current status of trial NCT01610570?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2012-05-10. Estimated completion is 2014-05-21.
What interventions are being tested in trial NCT01610570?
The interventions under investigation include: Mithramycin (DRUG).
Who is sponsoring clinical trial NCT01610570?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01610570's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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