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← Retinoblastoma

NCT02097134 · STUDY IN CONTEXT

Intra-arterial Melphalan in Treating Younger Patients With Unilateral Retinoblastoma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

All Patients who are eligible and evaluable for the feasibility outcome are included in this outcome

→

secondary · POSTED

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.

One patient who did not receive protocol therapy was excluded.

→

secondary · POSTED

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.

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.

→

secondary · POSTED

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

One patient who did not receive protocol therapy was excluded.

→

secondary · POSTED

Estimated by the average visual acuity amongst patients evaluated with a 95% confidence interval.

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.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-retinoblastoma
nct id
NCT02097134
trial label
Intra-arterial Melphalan in Treating Younger Patients With Unilateral Retinoblastoma
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
5
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-retinoblastoma
    nct id
    NCT02097134
    outcome key
    om-0000
    source section id
    NCT02097134-om-0000
    source outcome index
    0
    endpoint
    Number of Patients Experiencing Feasibility Failure
    endpoint definition
    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.
    time origin
    Up to 4 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All Patients who are eligible and evaluable for the feasibility outcome are included in this outcome
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-retinoblastoma
    nct id
    NCT02097134
    outcome key
    om-0001
    source section id
    NCT02097134-om-0001
    source outcome index
    1
    endpoint
    Incidence of Grade 3 or Higher CTCAE Adverse Events Associated With Multiple Doses of IA Chemotherapy
    endpoint definition
    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.
    time origin
    Up to 30 days after completion of study treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    One patient who did not receive protocol therapy was excluded.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-retinoblastoma
    nct id
    NCT02097134
    outcome key
    om-0002
    source section id
    NCT02097134-om-0002
    source outcome index
    2
    endpoint
    Probability of Ocular Salvage
    endpoint definition
    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.
    time origin
    2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-retinoblastoma
    nct id
    NCT02097134
    outcome key
    om-0003
    source section id
    NCT02097134-om-0003
    source outcome index
    3
    endpoint
    Rate of Metastases of Retinoblastoma
    endpoint definition
    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
    time origin
    Up to 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    One patient who did not receive protocol therapy was excluded.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-retinoblastoma
    nct id
    NCT02097134
    outcome key
    om-0004
    source section id
    NCT02097134-om-0004
    source outcome index
    4
    endpoint
    Vision Acuity, Assessed According to the Amblyopia Treatment Study Visual Acuity Testing Protocol
    endpoint definition
    Estimated by the average visual acuity amongst patients evaluated with a 95% confidence interval.
    time origin
    1 year after therapy
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-retinoblastoma
    nct id
    NCT02097134
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Melphalan
    regimen
    Patients receive melphalan intra-arterial (IA) on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Melphalan: Given IA
    analyzed count
    12
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02097134-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-retinoblastoma
    nct id
    NCT02097134
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Melphalan
    regimen
    Patients will receive 1 intra-arterial injection (IA) of melphalan every 21- 30 days. Injections may be repeated every 21-30 days (up to a maximum of 3 cycles) assuming the patients meets the criteria to begin the next cycle.
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02097134-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-retinoblastoma
    nct id
    NCT02097134
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Melphalan
    regimen
    Patients will receive 1 intra-arterial injection (IA) of melphalan every 21- 30 days. Injections may be repeated every 21-30 days (up to a maximum of 3 cycles) assuming the patients meets the criteria to begin the next cycle.
    analyzed count
    11
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02097134-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-retinoblastoma
    nct id
    NCT02097134
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Melphalan
    regimen
    Patients will receive 1 intra-arterial injection (IA) of melphalan every 21- 30 days. Injections may be repeated every 21-30 days (up to a maximum of 3 cycles) assuming the patients meets the criteria to begin the next cycle.
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02097134-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-retinoblastoma
    nct id
    NCT02097134
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Melphalan
    regimen
    Patients will receive 1 intra-arterial injection (IA) of melphalan every 21- 30 days. Injections may be repeated every 21-30 days (up to a maximum of 3 cycles) assuming the patients meets the criteria to begin the next cycle.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02097134-om-0004#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-retinoblastoma
    nct id
    NCT02097134
    harm key
    EG000
    source section id
    NCT02097134-ae
    event group key
    EG000
    event group label
    Melphalan
    serious affected
    2
    serious at risk
    14
    other affected
    3
    other at risk
    14
    frequency threshold
    0
    collection period
    Up to 4 months
    event definition
    The Other Adverse Events field contains Common Terminology Criteria for Adverse Events (CTCAEs) reported on protocol therapy, excluding those that were reported as Serious Adverse Events. The Serious Adverse Events field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs).
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice