Trial Outcomes & Findings for Systemic Chemotherapy and Subtenon Carboplatin, and Local Ophthalmic Therapy in Children With Intraocular Retinoblastoma (NCT NCT00072384)

Last Updated: 2021-07-30

Results Overview

Each Group D eye will be classified as experiencing failure within one year after start of treatment: yes or no. The method of Rosner et al. (Biometrics v. 38, 105-114, 1982) will be used to model possible dependence between eyes from the same patient. The point estimate of the probability of treatment failure is reported as the "Mean" measure type.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

30 participants

Primary outcome timeframe

One year

Results posted on

2021-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Chemotherapy, Surgery) Patients receive liposomal vincristine sulfate IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 3 and continuing until blood counts recover. Patients receive subtenon carboplatin to each group C or D eye on day 0 or 1prior of courses 2-4 only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic chemotherapy, patients undergo local ophthalmic therapy comprising local laser surgery and/or cryosurgery on day 1. liposomal vincristine sulfate: Given IV cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue. laser surgery: Surgery using a laser (instead of a scalpel) to cut tissue carboplatin: Given IV etoposide: Given IV filgrastim: Given subcutaneously
Overall Study STARTED	30
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Chemotherapy, Surgery) Patients receive liposomal vincristine sulfate IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 3 and continuing until blood counts recover. Patients receive subtenon carboplatin to each group C or D eye on day 0 or 1prior of courses 2-4 only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic chemotherapy, patients undergo local ophthalmic therapy comprising local laser surgery and/or cryosurgery on day 1. liposomal vincristine sulfate: Given IV cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue. laser surgery: Surgery using a laser (instead of a scalpel) to cut tissue carboplatin: Given IV etoposide: Given IV filgrastim: Given subcutaneously
Overall Study Physician Decision	1
Overall Study Ineligible	8

Baseline Characteristics

Systemic Chemotherapy and Subtenon Carboplatin, and Local Ophthalmic Therapy in Children With Intraocular Retinoblastoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Chemotherapy, Surgery) n=30 Participants Patients receive liposomal vincristine sulfate IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 3 and continuing until blood counts recover. Patients receive subtenon carboplatin to each group C or D eye on day 0 or 1prior of courses 2-4 only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic chemotherapy, patients undergo local ophthalmic therapy comprising local laser surgery and/or cryosurgery on day 1. liposomal vincristine sulfate: Given IV cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue. laser surgery: Surgery using a laser (instead of a scalpel) to cut tissue carboplatin: Given IV etoposide: Given IV filgrastim: Given subcutaneously
Age, Continuous	7.5 months n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: One year

Population: Twenty eligible patients had at least one Group D eye to contribute to the analysis. A total of 25 Group D eyes were available for analysis.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, Surgery) n=25 Eyes Patients receive liposomal vincristine sulfate IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 3 and continuing until blood counts recover. Patients receive subtenon carboplatin to each group C or D eye on day 0 or 1prior of courses 2-4 only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic chemotherapy, patients undergo local ophthalmic therapy comprising local laser surgery and/or cryosurgery on day 1. liposomal vincristine sulfate: Given IV cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue. laser surgery: Surgery using a laser (instead of a scalpel) to cut tissue carboplatin: Given IV etoposide: Given IV filgrastim: Given subcutaneously	Group D Eyes Group D: Diffuse disease with significant vitreous and/or subretinal seeding * Tumor(s) may be massive or diffuse * Subretinal fluid, without prior or concurrent seeding, involving up to total retinal detachment * Diffuse or massive vitreous disease may include "greasy" seeds or avascular tumor masses * Diffuse subretinal seeding may include subretinal plaques or tumor nodules
Group D Eyes - Treatment Failure Within One Year	0.52 Probability of treatment failure Standard Deviation 0.102299	—

PRIMARY outcome

Timeframe: One year

Population: Four eligible patients had at least one Group C eye to contribute to the analysis

Each Group C eye will be classified as experiencing failure within one year after start of treatment: yes or no. The method of Rosner et al. (Biometrics v. 38, 105-114, 1982) will be used to model possible dependence between eyes from the same patient. The point estimate of the probability of treatment failure is reported as the "Mean" measure type.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, Surgery) n=4 Eyes Patients receive liposomal vincristine sulfate IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 3 and continuing until blood counts recover. Patients receive subtenon carboplatin to each group C or D eye on day 0 or 1prior of courses 2-4 only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic chemotherapy, patients undergo local ophthalmic therapy comprising local laser surgery and/or cryosurgery on day 1. liposomal vincristine sulfate: Given IV cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue. laser surgery: Surgery using a laser (instead of a scalpel) to cut tissue carboplatin: Given IV etoposide: Given IV filgrastim: Given subcutaneously	Group D Eyes Group D: Diffuse disease with significant vitreous and/or subretinal seeding * Tumor(s) may be massive or diffuse * Subretinal fluid, without prior or concurrent seeding, involving up to total retinal detachment * Diffuse or massive vitreous disease may include "greasy" seeds or avascular tumor masses * Diffuse subretinal seeding may include subretinal plaques or tumor nodules
Group C Eyes - Treatment Failure Within One Year	0.25 Probability of treatment failure Standard Deviation 0.217	—

SECONDARY outcome

Timeframe: One year after study enrollment

Population: 22 eligible patients were considered for this endpoint.

Proportion of patients event free at 1 year following enrollment. Event free survival time is computed as the time to study entry until disease relapse/progression, secondary malignancy, or death.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, Surgery) n=22 Participants Patients receive liposomal vincristine sulfate IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 3 and continuing until blood counts recover. Patients receive subtenon carboplatin to each group C or D eye on day 0 or 1prior of courses 2-4 only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic chemotherapy, patients undergo local ophthalmic therapy comprising local laser surgery and/or cryosurgery on day 1. liposomal vincristine sulfate: Given IV cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue. laser surgery: Surgery using a laser (instead of a scalpel) to cut tissue carboplatin: Given IV etoposide: Given IV filgrastim: Given subcutaneously	Group D Eyes Group D: Diffuse disease with significant vitreous and/or subretinal seeding * Tumor(s) may be massive or diffuse * Subretinal fluid, without prior or concurrent seeding, involving up to total retinal detachment * Diffuse or massive vitreous disease may include "greasy" seeds or avascular tumor masses * Diffuse subretinal seeding may include subretinal plaques or tumor nodules
Event-free Survival (EFS)	45.45 Percentage probability Interval 24.44 to 64.33	—

SECONDARY outcome

Timeframe: From date of enrollment until termination of protocol therapy assessed up to 72 weeks

Population: 22 eligible patients were evaluable for the occurrence of grade 3 or higher toxicity of any kind.

The number of patients that experience CTC Version 4 grade 3 or higher toxicities of any kind.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, Surgery) n=22 Participants Patients receive liposomal vincristine sulfate IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 3 and continuing until blood counts recover. Patients receive subtenon carboplatin to each group C or D eye on day 0 or 1prior of courses 2-4 only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic chemotherapy, patients undergo local ophthalmic therapy comprising local laser surgery and/or cryosurgery on day 1. liposomal vincristine sulfate: Given IV cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue. laser surgery: Surgery using a laser (instead of a scalpel) to cut tissue carboplatin: Given IV etoposide: Given IV filgrastim: Given subcutaneously	Group D Eyes Group D: Diffuse disease with significant vitreous and/or subretinal seeding * Tumor(s) may be massive or diffuse * Subretinal fluid, without prior or concurrent seeding, involving up to total retinal detachment * Diffuse or massive vitreous disease may include "greasy" seeds or avascular tumor masses * Diffuse subretinal seeding may include subretinal plaques or tumor nodules
Toxicity Associated With Chemotherapy	10 Patients	—

SECONDARY outcome

Timeframe: From the date of enrollment assessed up to 36 months

Population: 1 patient had at least one Group C eye and 11 patients had at least one Group D eye that experienced treatment failure. There were a total of 13 Group D eyes that experienced treatment failure.

Sites of disease recurrence for Group C and Group D eyes where treatment failure was detected

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, Surgery) n=1 Participants Patients receive liposomal vincristine sulfate IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 3 and continuing until blood counts recover. Patients receive subtenon carboplatin to each group C or D eye on day 0 or 1prior of courses 2-4 only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic chemotherapy, patients undergo local ophthalmic therapy comprising local laser surgery and/or cryosurgery on day 1. liposomal vincristine sulfate: Given IV cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue. laser surgery: Surgery using a laser (instead of a scalpel) to cut tissue carboplatin: Given IV etoposide: Given IV filgrastim: Given subcutaneously	Group D Eyes n=11 Participants Group D: Diffuse disease with significant vitreous and/or subretinal seeding * Tumor(s) may be massive or diffuse * Subretinal fluid, without prior or concurrent seeding, involving up to total retinal detachment * Diffuse or massive vitreous disease may include "greasy" seeds or avascular tumor masses * Diffuse subretinal seeding may include subretinal plaques or tumor nodules
Patterns of Failure for Group C and Group D in Terms of Vitreous vs Patterns of Failure for Group C and Group D in Terms of Vitreous vs Retinal vs Both as Sites of Recurrence Neither retinal seeding nor vitreal seeding	0 Eyes	4 Eyes
Patterns of Failure for Group C and Group D in Terms of Vitreous vs Patterns of Failure for Group C and Group D in Terms of Vitreous vs Retinal vs Both as Sites of Recurrence Retinal seeding and vitreal seeding	0 Eyes	1 Eyes
Patterns of Failure for Group C and Group D in Terms of Vitreous vs Patterns of Failure for Group C and Group D in Terms of Vitreous vs Retinal vs Both as Sites of Recurrence Retinal seeding but no vitreal seeding	1 Eyes	7 Eyes
Patterns of Failure for Group C and Group D in Terms of Vitreous vs Patterns of Failure for Group C and Group D in Terms of Vitreous vs Retinal vs Both as Sites of Recurrence Vitreal seeding but no retinal seeding	0 Eyes	1 Eyes

SECONDARY outcome

Timeframe: From the date of enrollment assessed up to 12 months

Population: According to the initial sites of involvement, 4 patients were analyzed in Group C eyes and 20 patients were analyzed for Group D eyes

The association between the probability of experiencing treatment failure vs. no failure in a C eye and the presence of subretinal seeding (SRS), subretinal fluid (SRF), or vitreal seeding (VS) at the on study ophthalmological examination under anesthesia. The association between the probability of experiencing treatment failure vs. no failure in a D eye and the presence of subretinal seeding (SRS), subretinal fluid (SRF), or vitreal seeding (VS) at the on study ophthalmological examination under anesthesia.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, Surgery) n=4 Participants Patients receive liposomal vincristine sulfate IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 3 and continuing until blood counts recover. Patients receive subtenon carboplatin to each group C or D eye on day 0 or 1prior of courses 2-4 only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic chemotherapy, patients undergo local ophthalmic therapy comprising local laser surgery and/or cryosurgery on day 1. liposomal vincristine sulfate: Given IV cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue. laser surgery: Surgery using a laser (instead of a scalpel) to cut tissue carboplatin: Given IV etoposide: Given IV filgrastim: Given subcutaneously	Group D Eyes n=20 Participants Group D: Diffuse disease with significant vitreous and/or subretinal seeding * Tumor(s) may be massive or diffuse * Subretinal fluid, without prior or concurrent seeding, involving up to total retinal detachment * Diffuse or massive vitreous disease may include "greasy" seeds or avascular tumor masses * Diffuse subretinal seeding may include subretinal plaques or tumor nodules
Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement Treatment failure- SRS, SRF, VS	0 Eyes	3 Eyes
Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement Treatment failure- SRS; no SRF; no VS	0 Eyes	0 Eyes
Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement Treatment failure- SRS and SRF; no VS	0 Eyes	3 Eyes
Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement Treatment failure- SRS and VS; no SRF	0 Eyes	0 Eyes
Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement Treatment failure- SRF; no SRS; no VS	1 Eyes	2 Eyes
Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement Treatment failure- SRF and VS; no SRS	0 Eyes	3 Eyes
Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement Treatment failure- VS; no SRS; no SRF	0 Eyes	2 Eyes
Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement Treatment failure- No SRS; no VS; no SRF	0 Eyes	0 Eyes
Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement No treatment failure- SRS, SRF, VS	0 Eyes	2 Eyes
Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement No treatment failure- SRS; no SRF; no VS	0 Eyes	1 Eyes
Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement No treatment failure- SRS and SRF; no VS	0 Eyes	2 Eyes
Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement No treatment failure- SRS and VS; no SRF	0 Eyes	2 Eyes
Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement No treatment failure- SRF; no SRS; no VS	1 Eyes	2 Eyes
Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement No treatment failure- SRF and VS; no SRS	0 Eyes	0 Eyes
Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement No treatment failure- VS; no SRS; no SRF	1 Eyes	2 Eyes
Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement No treatment failure- No SRS; no VS; no SRF	1 Eyes	1 Eyes

Adverse Events

Treatment (Chemotherapy, Surgery)

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Chemotherapy, Surgery) n=22 participants at risk Patients receive liposomal vincristine sulfate IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 3 and continuing until blood counts recover. Patients receive subtenon carboplatin to each group C or D eye on day 0 or 1prior of courses 2-4 only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic chemotherapy, patients undergo local ophthalmic therapy comprising local laser surgery and/or cryosurgery on day 1. liposomal vincristine sulfate: Given IV cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue. laser surgery: Surgery using a laser (instead of a scalpel) to cut tissue carboplatin: Given IV etoposide: Given IV filgrastim: Given subcutaneously
Infections and infestations Anorectal infection	4.5% 1/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Note that while the participant flow demonstrates that 21 completed all cycles of therapy, one additional patient completed fewer than 6 cycles of therapy. The AE profiles are calculated on a per-person basis for the time during which the patient was on therapy.
Infections and infestations Bladder infection	4.5% 1/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Note that while the participant flow demonstrates that 21 completed all cycles of therapy, one additional patient completed fewer than 6 cycles of therapy. The AE profiles are calculated on a per-person basis for the time during which the patient was on therapy.
Infections and infestations Device related infection	4.5% 1/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Note that while the participant flow demonstrates that 21 completed all cycles of therapy, one additional patient completed fewer than 6 cycles of therapy. The AE profiles are calculated on a per-person basis for the time during which the patient was on therapy.
Eye disorders Eye disorders - Other, specify	9.1% 2/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Note that while the participant flow demonstrates that 21 completed all cycles of therapy, one additional patient completed fewer than 6 cycles of therapy. The AE profiles are calculated on a per-person basis for the time during which the patient was on therapy.
Infections and infestations Eye infection	4.5% 1/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Note that while the participant flow demonstrates that 21 completed all cycles of therapy, one additional patient completed fewer than 6 cycles of therapy. The AE profiles are calculated on a per-person basis for the time during which the patient was on therapy.
Blood and lymphatic system disorders Febrile neutropenia	4.5% 1/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Note that while the participant flow demonstrates that 21 completed all cycles of therapy, one additional patient completed fewer than 6 cycles of therapy. The AE profiles are calculated on a per-person basis for the time during which the patient was on therapy.
Ear and labyrinth disorders Hearing impaired	9.1% 2/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Note that while the participant flow demonstrates that 21 completed all cycles of therapy, one additional patient completed fewer than 6 cycles of therapy. The AE profiles are calculated on a per-person basis for the time during which the patient was on therapy.
Infections and infestations Infections and infestations - Other, specify	9.1% 2/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Note that while the participant flow demonstrates that 21 completed all cycles of therapy, one additional patient completed fewer than 6 cycles of therapy. The AE profiles are calculated on a per-person basis for the time during which the patient was on therapy.
Infections and infestations Lung infection	4.5% 1/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Note that while the participant flow demonstrates that 21 completed all cycles of therapy, one additional patient completed fewer than 6 cycles of therapy. The AE profiles are calculated on a per-person basis for the time during which the patient was on therapy.
Ear and labyrinth disorders Middle ear inflammation	4.5% 1/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Note that while the participant flow demonstrates that 21 completed all cycles of therapy, one additional patient completed fewer than 6 cycles of therapy. The AE profiles are calculated on a per-person basis for the time during which the patient was on therapy.
Investigations Neutrophil count decreased	13.6% 3/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Note that while the participant flow demonstrates that 21 completed all cycles of therapy, one additional patient completed fewer than 6 cycles of therapy. The AE profiles are calculated on a per-person basis for the time during which the patient was on therapy.
Investigations Platelet count decreased	4.5% 1/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Note that while the participant flow demonstrates that 21 completed all cycles of therapy, one additional patient completed fewer than 6 cycles of therapy. The AE profiles are calculated on a per-person basis for the time during which the patient was on therapy.
Skin and subcutaneous tissue disorders Skin induration	4.5% 1/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Note that while the participant flow demonstrates that 21 completed all cycles of therapy, one additional patient completed fewer than 6 cycles of therapy. The AE profiles are calculated on a per-person basis for the time during which the patient was on therapy.

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
Publication restrictions are in place

Restriction type: OTHER