Trial · NCT02859415
Continuous 24h Intravenous Infusion of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in People With Primary Thoracic Malignancies or Carcinomas, Sarcomas or Germ Cell Neoplasms With Pleuropulmonary Metastases
NCT02859415, Phase 1, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2022-04-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Continuous 24h Intravenous Infusion of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in People With Primary Thoracic Malignancies or Carcinomas, Sarcomas or Germ Cell Neoplasms With Pleuropulmonary Metastases. Trials, record NCT02859415. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02859415
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Continuous 24h Intravenous Infusion of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in People With Primary Thoracic Malignancies or Carcinomas, Sarcomas or Germ Cell Neoplasms With Pleuropulmonary Metastases
- NCT number
- NCT02859415
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Esophageal Neoplasms, Lung Neoplasms, Mesothelioma, Thymus Neoplasms, Neoplasms, Germ Cell and Embryonal
- Interventions
- Mithramycin
- First posted
- 2016-08-09
- Last updated
- 2022-04-05
- Results first posted
- 2022-04-05
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) | At the end of first 14 day cycle at each dose level | MTD is defined as the number of participants experiencing a dose-limiting toxicity (DLT). A DLT is defined as Grade 4 or greater anemia or neutropenia exceeding 5 days duration, thrombocytopenia requiring transfusion, or Grade 3 or greater nonhematologic toxicity possibly, probably, or definitely related to the investigational therapy excluding alopecia during Cycle 1 of therapy. |
| Primary | Number of Participants Whose Best Response is a Complete Response (CR) or Partial Response (PR) | every 8 weeks until at disease progression, approximately 3.5 months | Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | To Ascertain if Mithramycin Inhibits Stem Cell Gene Expression in Participants With Thoracic Malignancies | baseline, Cycle 1 Day 4 (+/- 3 days), and possible treatment evaluation following Course 1 | Studies on tumor tissue obtained during baseline /previous biopsy (if available), Cycle 1 Day 4(+/- 3 days), and possible treatment evaluation following Course 1. Plasma and blood will also be collected. |
| Secondary | To Evaluate Gene Expression, Deoxyribonucleic Acid (DNA) Methylation and Micro-ribonucleic Acid (RNA) Profiles in Pre- and Post-treatment Tumor Biopsies | baseline, Cycle 1 Day 4 (+/- 3 days), and possible treatment evaluation following Course 1 | Studies on tumor tissue obtained during baseline /previous biopsy (if available), Cycle 1 Day 4(+/- 3 days), and possible treatment evaluation following Course 1. |
| Secondary | To Compare Gene Expression, Deoxyribonucleic Acid (DNA) Methylation and Micro-ribonucleic Acid (RNA) Profiles in Participant Tumor Biopsies With Treatment Response Profiles in Pre-clinical Studies | baseline, Cycle 1 Day 4 (+/- 3 days), and possible treatment evaluation following Course 1 | Studies on tumor tissue obtained during baseline /previous biopsy (if available), Cycle 1 Day 4(+/- 3 days), and possible treatment evaluation following Course 1. |
| Secondary | To Examine if Mithramycin Decreases Pluripotent Cancer Stem Cells (Side Population) | baseline, Cycle 1 Day 4 (+/- 3 days), and possible treatment evaluation following Course 1 | Studies on tumor tissue obtained during baseline /previous biopsy (if available), Cycle 1 Day 4(+/- 3 days), and possible treatment evaluation following Course 1. |
| Secondary | To Develop Methodologies for Assessing Effects of Mithramycin on Cancer Stem Cells, Hematopoietic Stem Cells, Mesenchymal Stem Cells, and Circulating Tumor Cells (CTC) | baseline, Cycle 1 Day 4 (+/- 3 days), and possible treatment evaluation following Course 1 | Studies on tumor tissue obtained during baseline /previous biopsy (if available), Cycle 1 Day 4(+/- 3 days), and possible treatment evaluation following Course 1. Plasma and blood will also be collected. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Date treatment consent signed to date off study, approximately 1 month and 4 days, and 3 months and 17 days for the first and second group respectively. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Other | Number of Participants With a Dose-limiting Toxicity (DLT) | Cycle 1 | A DLT is defined as Grade 4 or greater anemia or neutropenia exceeding 5 days duration, thrombocytopenia requiring transfusion, or Grade 3 or greater nonhematologic toxicity possibly, probably, or definitely related to the investigational therapy excluding alopecia during Cycle 1 of therapy. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) | At the end of first 14 day cycle at each dose level | mcg/kg | NUMBER | |
| PRIMARY | Number of Participants Whose Best Response is a Complete Response (CR) or Partial Response (PR) | every 8 weeks until at disease progression, approximately 3.5 months | One participant in the first group only received one dose, thus was not evaluable. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | To Ascertain if Mithramycin Inhibits Stem Cell Gene Expression in Participants With Thoracic Malignancies | baseline, Cycle 1 Day 4 (+/- 3 days), and possible treatment evaluation following Course 1 | No data was collected thus this outcome measure was not done. | ||
| SECONDARY | To Evaluate Gene Expression, Deoxyribonucleic Acid (DNA) Methylation and Micro-ribonucleic Acid (RNA) Profiles in Pre- and Post-treatment Tumor Biopsies | baseline, Cycle 1 Day 4 (+/- 3 days), and possible treatment evaluation following Course 1 | No data was collected thus this outcome measure was not done. | ||
| SECONDARY | To Compare Gene Expression, Deoxyribonucleic Acid (DNA) Methylation and Micro-ribonucleic Acid (RNA) Profiles in Participant Tumor Biopsies With Treatment Response Profiles in Pre-clinical Studies | baseline, Cycle 1 Day 4 (+/- 3 days), and possible treatment evaluation following Course 1 | No data was collected thus this outcome measure was not done. | ||
| SECONDARY | To Examine if Mithramycin Decreases Pluripotent Cancer Stem Cells (Side Population) | baseline, Cycle 1 Day 4 (+/- 3 days), and possible treatment evaluation following Course 1 | No data was collected thus this outcome measure was not done. | ||
| SECONDARY | To Develop Methodologies for Assessing Effects of Mithramycin on Cancer Stem Cells, Hematopoietic Stem Cells, Mesenchymal Stem Cells, and Circulating Tumor Cells (CTC) | baseline, Cycle 1 Day 4 (+/- 3 days), and possible treatment evaluation following Course 1 | No data was collected thus this outcome measure was not done. | ||
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Date treatment consent signed to date off study, approximately 1 month and 4 days, and 3 months and 17 days for the first and second group respectively. | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With a Dose-limiting Toxicity (DLT) | Cycle 1 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) | All Participants | NA | mcg/kg | ||
| Number of Participants Whose Best Response is a Complete Response (CR) or Partial Response (PR) | Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg | Complete Response | 0 | Participants | |
| Number of Participants Whose Best Response is a Complete Response (CR) or Partial Response (PR) | Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg | Partial Response | 0 | Participants | |
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Phase I Dose Level 1 Mithramycin 60 mcg/kg | 1 | Participants | ||
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg | 2 | Participants | ||
| Number of Participants With a Dose-limiting Toxicity (DLT) | Phase I Dose Level 1 Mithramycin 60 mcg/kg | 0 | Participants | ||
| Number of Participants With a Dose-limiting Toxicity (DLT) | Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I Dose Level 1 Mithramycin 60 mcg/kg | 1 | |
| Overall Study | STARTED | Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg | 2 | |
| Overall Study | COMPLETED | Phase I Dose Level 1 Mithramycin 60 mcg/kg | 0 | |
| Overall Study | COMPLETED | Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg | 1 | |
| Overall Study | NOT COMPLETED | Phase I Dose Level 1 Mithramycin 60 mcg/kg | 1 | |
| Overall Study | NOT COMPLETED | Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg | 1 |
Source ClinicalTrials.gov
Adverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Activated partial thromboplastin time prolonged | Investigations | Phase I Dose Level 1 Mithramycin 60 mcg/kg | 0 | 1 | 0 |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg | 1 | 2 | 1 |
| other | Alanine aminotransferase increased | Investigations | Phase I Dose Level 1 Mithramycin 60 mcg/kg | 1 | 1 | 2 |
| other | Alanine aminotransferase increased | Investigations | Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg | 1 | 2 | 4 |
| other | Anemia | Blood and lymphatic system disorders | Phase I Dose Level 1 Mithramycin 60 mcg/kg | 0 | 1 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg | 2 | 2 | 19 |
| other | Aspartate aminotransferase increased | Investigations | Phase I Dose Level 1 Mithramycin 60 mcg/kg | 1 | 1 | 2 |
| other | Aspartate aminotransferase increased | Investigations | Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg | 1 | 2 | 3 |
| other | Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | Phase I Dose Level 1 Mithramycin 60 mcg/kg | 1 | 1 | 1 |
| other | Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg | 0 | 2 | 0 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I Dose Level 1 Mithramycin 60 mcg/kg | 0 | 1 |
| Total, all-cause mortality | Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg | 0 | 2 |
| Total, other adverse events | Phase I Dose Level 1 Mithramycin 60 mcg/kg | 1 | 1 |
| Total, other adverse events | Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg | 2 | 2 |
| Total, serious adverse events | Phase I Dose Level 1 Mithramycin 60 mcg/kg | 0 | 1 |
| Total, serious adverse events | Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg | 2 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Phase I Dose Level 1 Mithramycin 60 mcg/kg vs Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Trial comparisons |
| Phase I Dose Level 1 Mithramycin 60 mcg/kg vs Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg: deaths from any cause | Trial comparisons |
| Phase I Dose Level 1 Mithramycin 60 mcg/kg vs Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg: Number of Participants With a Dose-limiting Toxicity (DLT) | Trial comparisons |
| Phase I Dose Level 1 Mithramycin 60 mcg/kg vs Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02859415
GET https://conductscience.org/api/trials/v1/NCT02859415/events?page=2