Trial · NCT02097134
Intra-arterial Melphalan in Treating Younger Patients With Unilateral Retinoblastoma
NCT02097134, Phase 1, Completed, Children's Oncology Group; results first posted 2018-06-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intra-arterial Melphalan in Treating Younger Patients With Unilateral Retinoblastoma. Trials, record NCT02097134. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02097134
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intra-arterial Melphalan in Treating Younger Patients With Unilateral Retinoblastoma
- NCT number
- NCT02097134
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 14 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Unilateral Retinoblastoma
- Interventions
- Melphalan
- First posted
- 2014-03-26
- Last updated
- 2023-10-13
- Results first posted
- 2018-06-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Experiencing Feasibility Failure | Up to 4 months | Feasibility failure is defined as a) interventional radiologist is unable to access the ophthalmic artery for the 1st chemotherapy administration for any reason; b) patient develops central retinal artery occlusion after the 1st or 2nd course that does not reopen by the time the next injection is due; or c) the patient cannot receive all three treatments because of Common Terminology Criteria for Adverse Events (CTCAE) complications grade III or IV that are considered possibly, probably or likely related treatment. |
| Secondary | Incidence of Grade 3 or Higher CTCAE Adverse Events Associated With Multiple Doses of IA Chemotherapy | Up to 30 days after completion of study treatment | The percentage of patients with at least 1 occurrence of grade 3 or higher CTCAE adverse experience will be provided. Ineligible patients or patients who do not receive any protocol therapy are excluded from reporting of adverse events. |
| Secondary | Probability of Ocular Salvage | 2 years | A patient will be considered an ocular-salvage success if enucleation because of disease progression or toxicity is not required during the 2 years following enrollment. |
| Secondary | Rate of Metastases of Retinoblastoma | Up to 2 years | The percentage of patients who experience metastases of retinoblastoma will be estimated. Ineligible patients or patients who do not receive any protocol therapy are excluded from this analysis |
| Secondary | Vision Acuity, Assessed According to the Amblyopia Treatment Study Visual Acuity Testing Protocol | 1 year after therapy | Estimated by the average visual acuity amongst patients evaluated with a 95% confidence interval. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Experiencing Feasibility Failure | Up to 4 months | All Patients who are eligible and evaluable for the feasibility outcome are included in this outcome | participants | NUMBER |
| SECONDARY | Incidence of Grade 3 or Higher CTCAE Adverse Events Associated With Multiple Doses of IA Chemotherapy | Up to 30 days after completion of study treatment | One patient who did not receive protocol therapy was excluded. | Percentage of patients | NUMBER |
| SECONDARY | Probability of Ocular Salvage | 2 years | One patient who did not receive protocol therapy was excluded. Two patients who were lost to follow-up or follow-up was terminated electively prior to 2 years by patient or parent preference were excluded. | Percentage of patients | NUMBER |
| SECONDARY | Rate of Metastases of Retinoblastoma | Up to 2 years | One patient who did not receive protocol therapy was excluded. | Percentage of Patients | NUMBER |
| SECONDARY | Vision Acuity, Assessed According to the Amblyopia Treatment Study Visual Acuity Testing Protocol | 1 year after therapy | The study was terminated at stage I since the therapy was considered not feasible to deliver.~No patients had this data available. Patients either had affected eye enucleated, or did not complete protocol therapy. |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Experiencing Feasibility Failure | Melphalan | 4 | participants | ||
| Incidence of Grade 3 or Higher CTCAE Adverse Events Associated With Multiple Doses of IA Chemotherapy | Melphalan | 38 | 95% Confidence Interval 18 to 64 | Percentage of patients | |
| Probability of Ocular Salvage | Melphalan | 36 | 95% Confidence Interval 15 to 65 | Percentage of patients | |
| Rate of Metastases of Retinoblastoma | Melphalan | 0 | Percentage of Patients |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Melphalan | 14 | |
| Overall Study | COMPLETED | Melphalan | 5 | |
| Overall Study | NOT COMPLETED | Melphalan | 9 |
Source ClinicalTrials.gov
Adverse events6
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 | Anaphylaxis | Immune system disorders | Melphalan | 1 | 14 | |
| other | Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Melphalan | 1 | 14 | |
| other | Neutrophil count decreased | Investigations | Melphalan | 2 | 14 | |
| other | Platelet count decreased | Investigations | Melphalan | 1 | 14 | |
| serious | Hypotension | Vascular disorders | Melphalan | 1 | 14 | |
| serious | Hypoxia | Respiratory, thoracic and mediastinal disorders | Melphalan | 1 | 14 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Melphalan | 0 | 14 |
| Total, other adverse events | Melphalan | 3 | 14 |
| Total, serious adverse events | Melphalan | 2 | 14 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 to 2013 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02097134
GET https://conductscience.org/api/trials/v1/NCT02097134/registered