Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma

• ClinicalTrials.gov Identifier: NCT01767194
• Recruitment Status: Completed
• First Posted: January 14, 2013
• Results First Posted: November 18, 2019
• Last Update Posted: October 24, 2022
• Sponsor: National Cancer Institute (NCI)
• Collaborator: United Therapeutics
• Information provided by (Responsible Party): National Cancer Institute (NCI)

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Ganglioneuroblastoma; Recurrent Neuroblastoma
• Interventions: Biological: Dinutuximab; Drug: Irinotecan Hydrochloride; Other: Laboratory Biomarker Analysis; Biological: Sargramostim; Drug: Temozolomide; Drug: Temsirolimus
• Enrollment: 73

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus)	Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)
Arm/Group Description	CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Temozolomide: Given PO Temsirolimus: Given IV	Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Dinutuximab: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Sargramostim: Given SC or IV Temozolomide: Given PO
Period Title: Overall Study
Started	19	54
Completed	1	11
Not Completed	18	43
Reason Not Completed
Adverse Event	1	1
Death	0	1
Lack of Efficacy	12	11
Physician Decision	2	23
Withdrawal by Subject	0	1
Ineligible	1	1
Refusal by patient/parent	2	4
Criteria not met on time for next cycle	0	1

Baseline Characteristics

Arm/Group Title		Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus)	Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)	Total
Arm/Group Description		CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Temozolomide: Given PO Temsirolimus: Given IV	Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Dinutuximab: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Sargramostim: Given SC or IV Temozolomide: Given PO	Total of all reporting groups
Overall Number of Baseline Participants		19	54	73
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	19 participants	54 participants	73 participants
	<=18 years	19 100.0%	54 100.0%	73 100.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	19 participants	54 participants	73 participants
		7.2; (2.9 to 16.2)	4.9; (1.3 to 15.9)	5.7; (1.3 to 16.2)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	19 participants	54 participants	73 participants
	Female	8 42.1%	21 38.9%	29 39.7%
	Male	11 57.9%	33 61.1%	44 60.3%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	19 participants	54 participants	73 participants
	Hispanic or Latino	5 26.3%	8 14.8%	13 17.8%
	Not Hispanic or Latino	14 73.7%	43 79.6%	57 78.1%
	Unknown or Not Reported	0 0.0%	3 5.6%	3 4.1%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	19 participants	54 participants	73 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	1 5.3%	3 5.6%	4 5.5%
	Native Hawaiian or Other Pacific Islander	0 0.0%	2 3.7%	2 2.7%
	Black or African American	3 15.8%	7 13.0%	10 13.7%
	White	14 73.7%	36 66.7%	50 68.5%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	1 5.3%	6 11.1%	7 9.6%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	19 participants	54 participants	73 participants
United States		15	45	60
Canada		2	5	7
Australia		2	2	4
New Zealand		0	2	2

Outcome Measures

1. Primary Outcome

Title	Percentage of Randomized Patients Who Are Responders
Description	The percentage of patients who are responders will be tabulated, including a 95% confidence interval on the response rate. Responders are defined as patients who achieve a best overall response of complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Neuroblastoma Response Criteria (INRC). Per INRC: CR= Disappearance of all target lesions. No evidence of tumor at any site; VGPR= >90% decrease of the disease measurement for CT/MRI target lesions. All pre-existing bone lesions with CR by MIBG; MIBG scan can be stable disease (SD) or CR in soft tissue lesions corresponding to lesions on CT/MRI. CR in bone marrow. No new sites of tumor; PR= >=30% decrease in the disease measurement for CT/MRI target lesions. Bone marrow with CR. MIBG with either PR/CR in bone lesions; MIBG may be SD or CR in soft tissue lesions corresponding to lesions on CT/MRI. Homovanillic acid (HVA)/Vanillylmandelic acid (VMA) may still be elevated.
Time Frame	Up to the first 6 cycles of treatment

Outcome Measure Data

Analysis Population Description

Includes all eligible patients randomly assigned to Arm I or Arm II. Of the 19 participants randomized to Arm I, one was ineligible and not included in the analysis. Of the 54 participants assigned to Arm II, 1 was ineligible and 36 were non-randomly assigned, and not included in the analysis.

Arm/Group Title	Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus)	Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)
Arm/Group Description:	CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Temozolomide: Given PO Temsirolimus: Given IV	Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Dinutuximab: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Sargramostim: Given SC or IV Temozolomide: Given PO
Overall Number of Participants Analyzed	18	17
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of patients
	5.6; (0.0 to 16.1)	52.9; (29.2 to 76.7)

2. Primary Outcome

Title	Percentage of Patients in the Dinutuximab Arm Who Are Responders
Description	Percentage of patients who are responders to therapy with dinutuximab will be tabulated, including a 95% confidence interval on the response rate. Responders are defined as patients who achieve a best overall response of complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Neuroblastoma Response Criteria (INRC). Per INRC: CR= Disappearance of all target lesions. No evidence of tumor at any site; VGPR= >90% decrease of disease measurement for CT/MRI target lesions. All pre-existing bone lesions with CR by MIBG; MIBG scan can be stable disease (SD) or CR in soft tissue lesions corresponding to lesions on CT/MRI. CR in bone marrow. No new sites of tumor; PR= ≥30% decrease in disease measurement for CT/MRI target lesions. Bone marrow with CR. MIBG with either PR/CR in bone lesions; MIBG may be SD or CR in soft tissue lesions corresponding to lesions on CT/MRI. Homovanillic acid (HVA)/ Vanillylmandelic acid (VMA) may still be elevated.
Time Frame	Up to the first 6 cycles of treatment

Outcome Measure Data

Analysis Population Description

Includes all eligible patients either randomized or non-randomly assigned to Arm II. Of the 54 participants assigned to Arm II, 1 was ineligible and not included in the analysis. The remaining 53 eligible participants are included in the analysis, 17 randomized and 36 non-randomly assigned to Arm II.

Arm/Group Title	Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)
Arm/Group Description:	Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Dinutuximab: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Sargramostim: Given SC or IV Temozolomide: Given PO
Overall Number of Participants Analyzed	53
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of patients
	41.2; (28.2 to 54.8)

3. Other Pre-specified Outcome

Title	Progression-free Survival
Description	Kaplan-Meier method will be used to estimate progression-free survival. Progression-free survival will be defined as the time from enrollment to relapse, progressive disease, or death attributable to tumor or treatment.
Time Frame	Up to 3 years

Outcome Measure Data Not Reported

4. Other Pre-specified Outcome

Title	Overall Survival
Description	Kaplan-Meier method will be used to estimate overall survival. Overall survival is defined as the time from enrollment on the study until death.
Time Frame	Up to 3 years

Outcome Measure Data Not Reported

5. Other Pre-specified Outcome

Title	Occurrence of Unacceptable Toxicities
Description	The proportion of patients with at least one grade 3 or higher toxicity, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Time Frame	Up to 1 year

Outcome Measure Data Not Reported

6. Other Pre-specified Outcome

Title	Ability to Maintain Intended Treatment Without a Dose Reduction or Going Off Protocol Therapy for Toxicity
Description	The proportion of patients who required a dose modification or went off protocol therapy for toxicity will be calculated for each treatment group.
Time Frame	Up to 1 year

Outcome Measure Data Not Reported

7. Other Pre-specified Outcome

Title	Overall Response
Description	The proportion of patients achieving each type of overall response (complete response, partial response, stable disease, progressive disease) will be calculated according to the International Neuroblastoma Response Criteria (INRC).
Time Frame	Up to the first 6 cycles of treatment

Outcome Measure Data Not Reported

Adverse Events

Time Frame	Through completion of protocol therapy, up to approximately 1 year.
Adverse Event Reporting Description	Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients and patients that reported not receiving treatment are excluded from reporting of adverse events.
Arm/Group Title	Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus)	Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)
Arm/Group Description	CLOSED TO ACCRUAL 06/17/2016 Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Temozolomide: Given PO Temsirolimus: Given IV	Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Dinutuximab: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Optional correlative studies Sargramostim: Given SC or IV Temozolomide: Given PO
All-Cause Mortality
	Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus)	Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	12/18 (66.67%)	15/51 (29.41%)
Serious Adverse Events
	Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus)	Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	5/18 (27.78%)	18/51 (35.29%)
Blood and lymphatic system disorders
Anemia † 1	1/18 (5.56%)	2/51 (3.92%)
Febrile neutropenia † 1	2/18 (11.11%)	0/51 (0.00%)
Ear and labyrinth disorders
Hearing impaired † 1	0/18 (0.00%)	1/51 (1.96%)
Eye disorders
TEMPORARY VISION LOSS † 1	0/18 (0.00%)	1/51 (1.96%)
Gastrointestinal disorders
Diarrhea † 1	2/18 (11.11%)	2/51 (3.92%)
Nausea † 1	0/18 (0.00%)	1/51 (1.96%)
Vomiting † 1	2/18 (11.11%)	0/51 (0.00%)
General disorders
Death NOS † 1	0/18 (0.00%)	1/51 (1.96%)
Fever † 1	1/18 (5.56%)	1/51 (1.96%)
Pain † 1	0/18 (0.00%)	1/51 (1.96%)
Immune system disorders
Allergic reaction † 1	1/18 (5.56%)	0/51 (0.00%)
Anaphylaxis † 1	0/18 (0.00%)	1/51 (1.96%)
Infections and infestations
BACTEREMIA - LINE INFECTIONS † 1	0/18 (0.00%)	1/51 (1.96%)
BLOOD † 1	1/18 (5.56%)	0/51 (0.00%)
Mucosal infection † 1	1/18 (5.56%)	0/51 (0.00%)
norovirus † 1	0/18 (0.00%)	1/51 (1.96%)
POSITIVE BLOOD CULTURES † 1	1/18 (5.56%)	0/51 (0.00%)
RSV † 1	0/18 (0.00%)	1/51 (1.96%)
Sepsis † 1	0/18 (0.00%)	1/51 (1.96%)
Small intestine infection † 1	0/18 (0.00%)	1/51 (1.96%)
Soft tissue infection † 1	0/18 (0.00%)	1/51 (1.96%)
Upper respiratory infection † 1	0/18 (0.00%)	1/51 (1.96%)
Injury, poisoning and procedural complications
Infusion related reaction † 1	1/18 (5.56%)	0/51 (0.00%)
Prolapse of intestinal stoma † 1	0/18 (0.00%)	1/51 (1.96%)
Investigations
Alanine aminotransferase increased † 1	1/18 (5.56%)	1/51 (1.96%)
Aspartate aminotransferase increased † 1	0/18 (0.00%)	2/51 (3.92%)
Creatinine increased † 1	0/18 (0.00%)	1/51 (1.96%)
GGT increased † 1	1/18 (5.56%)	1/51 (1.96%)
Neutrophil count decreased † 1	1/18 (5.56%)	4/51 (7.84%)
Platelet count decreased † 1	1/18 (5.56%)	0/51 (0.00%)
Urine output decreased † 1	0/18 (0.00%)	1/51 (1.96%)
Weight loss † 1	1/18 (5.56%)	0/51 (0.00%)
White blood cell decreased † 1	2/18 (11.11%)	1/51 (1.96%)
Metabolism and nutrition disorders
Anorexia † 1	1/18 (5.56%)	0/51 (0.00%)
Dehydration † 1	2/18 (11.11%)	1/51 (1.96%)
Hypokalemia † 1	1/18 (5.56%)	0/51 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain † 1	0/18 (0.00%)	1/51 (1.96%)
Nervous system disorders
Depressed level of consciousness † 1	0/18 (0.00%)	1/51 (1.96%)
Headache † 1	0/18 (0.00%)	1/51 (1.96%)
Peripheral motor neuropathy † 1	0/18 (0.00%)	1/51 (1.96%)
Renal and urinary disorders
Urinary retention † 1	0/18 (0.00%)	1/51 (1.96%)
Respiratory, thoracic and mediastinal disorders
Bronchospasm † 1	0/18 (0.00%)	1/51 (1.96%)
Dyspnea † 1	0/18 (0.00%)	2/51 (3.92%)
Hypoxia † 1	0/18 (0.00%)	3/51 (5.88%)
Wheezing † 1	0/18 (0.00%)	2/51 (3.92%)
Vascular disorders
Hypertension † 1	0/18 (0.00%)	1/51 (1.96%)
Hypotension † 1	0/18 (0.00%)	1/51 (1.96%)
1 Term from vocabulary, CTCAE version 5.0; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus)	Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	10/18 (55.56%)	39/51 (76.47%)
Blood and lymphatic system disorders
Anemia † 1	5/18 (27.78%)	12/51 (23.53%)
Febrile neutropenia † 1	1/18 (5.56%)	1/51 (1.96%)
Cardiac disorders
Cardiac arrest † 1	0/18 (0.00%)	1/51 (1.96%)
Eye disorders
Blurred vision † 1	0/18 (0.00%)	1/51 (1.96%)
Gastrointestinal disorders
Abdominal pain † 1	0/18 (0.00%)	3/51 (5.88%)
Diarrhea † 1	0/18 (0.00%)	8/51 (15.69%)
Enterocolitis † 1	0/18 (0.00%)	1/51 (1.96%)
Mucositis oral † 1	2/18 (11.11%)	0/51 (0.00%)
Nausea † 1	0/18 (0.00%)	1/51 (1.96%)
Oral pain † 1	1/18 (5.56%)	0/51 (0.00%)
Vomiting † 1	1/18 (5.56%)	5/51 (9.80%)
General disorders
Fatigue † 1	1/18 (5.56%)	1/51 (1.96%)
Fever † 1	0/18 (0.00%)	10/51 (19.61%)
Non-cardiac chest pain † 1	0/18 (0.00%)	1/51 (1.96%)
Pain † 1	0/18 (0.00%)	10/51 (19.61%)
Immune system disorders
Allergic reaction † 1	0/18 (0.00%)	1/51 (1.96%)
Infections and infestations
BACTEREMIA † 1	0/18 (0.00%)	1/51 (1.96%)
BLOOD † 1	1/18 (5.56%)	0/51 (0.00%)
BLOOD - STAPHYLOCOCCUS EPIDERMIDIS ISOLATED. † 1	0/18 (0.00%)	1/51 (1.96%)
BLOOD - STAPHYLOCOCCUS HOMINIS ISOLATES † 1	0/18 (0.00%)	1/51 (1.96%)
CENTRAL LINE INFECTION † 1	0/18 (0.00%)	1/51 (1.96%)
Enterocolitis infectious † 1	0/18 (0.00%)	1/51 (1.96%)
GRAM-POSITIVE BACILLI FROM PORT BLOOD CULTURE † 1	1/18 (5.56%)	0/51 (0.00%)
INFECTION † 1	0/18 (0.00%)	1/51 (1.96%)
LINE INFECTION † 1	0/18 (0.00%)	1/51 (1.96%)
Lung infection † 1	0/18 (0.00%)	1/51 (1.96%)
RESPIRATORY SYNCTIAL VIRUS (RSV) FROM NASAL SWAB † 1	0/18 (0.00%)	1/51 (1.96%)
Skin infection † 1	1/18 (5.56%)	1/51 (1.96%)
STAPH. WARNERI FROM WHITE LUMEN † 1	0/18 (0.00%)	1/51 (1.96%)
Urinary tract infection † 1	0/18 (0.00%)	3/51 (5.88%)
Investigations
Activated partial thromboplastin time prolonged † 1	0/18 (0.00%)	1/51 (1.96%)
Alanine aminotransferase increased † 1	4/18 (22.22%)	8/51 (15.69%)
Aspartate aminotransferase increased † 1	2/18 (11.11%)	2/51 (3.92%)
Blood bilirubin increased † 1	1/18 (5.56%)	0/51 (0.00%)
GGT increased † 1	0/18 (0.00%)	2/51 (3.92%)
Lymphocyte count decreased † 1	4/18 (22.22%)	13/51 (25.49%)
Lymphocyte count increased † 1	0/18 (0.00%)	1/51 (1.96%)
Neutrophil count decreased † 1	7/18 (38.89%)	13/51 (25.49%)
Platelet count decreased † 1	5/18 (27.78%)	6/51 (11.76%)
Urine output decreased † 1	0/18 (0.00%)	1/51 (1.96%)
Weight gain † 1	0/18 (0.00%)	1/51 (1.96%)
White blood cell decreased † 1	4/18 (22.22%)	14/51 (27.45%)
Metabolism and nutrition disorders
Anorexia † 1	2/18 (11.11%)	2/51 (3.92%)
Dehydration † 1	1/18 (5.56%)	3/51 (5.88%)
Hyperglycemia † 1	1/18 (5.56%)	3/51 (5.88%)
Hyperkalemia † 1	0/18 (0.00%)	2/51 (3.92%)
Hypoalbuminemia † 1	0/18 (0.00%)	1/51 (1.96%)
Hypocalcemia † 1	0/18 (0.00%)	4/51 (7.84%)
Hypokalemia † 1	4/18 (22.22%)	9/51 (17.65%)
Hypomagnesemia † 1	1/18 (5.56%)	0/51 (0.00%)
Hyponatremia † 1	0/18 (0.00%)	6/51 (11.76%)
Hypophosphatemia † 1	1/18 (5.56%)	1/51 (1.96%)
Musculoskeletal and connective tissue disorders
Back pain † 1	0/18 (0.00%)	1/51 (1.96%)
Pain in extremity † 1	0/18 (0.00%)	2/51 (3.92%)
Psychiatric disorders
Delirium † 1	0/18 (0.00%)	1/51 (1.96%)
Insomnia † 1	1/18 (5.56%)	0/51 (0.00%)
Irritability † 1	0/18 (0.00%)	2/51 (3.92%)
Renal and urinary disorders
Urinary retention † 1	0/18 (0.00%)	1/51 (1.96%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	0/18 (0.00%)	1/51 (1.96%)
Dyspnea † 1	0/18 (0.00%)	1/51 (1.96%)
Hypoxia † 1	0/18 (0.00%)	4/51 (7.84%)
Respiratory failure † 1	0/18 (0.00%)	1/51 (1.96%)
Skin and subcutaneous tissue disorders
Rash maculo-papular † 1	0/18 (0.00%)	1/51 (1.96%)
Vascular disorders
Capillary leak syndrome † 1	0/18 (0.00%)	2/51 (3.92%)
Hypotension † 1	0/18 (0.00%)	5/51 (9.80%)
1 Term from vocabulary, CTCAE version 5.0; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Results Reporting Coordinator
• Organization: Children's Oncology Group
• Phone: 626-447-0064
• EMail: resultsreportingcoordinator@childrensoncologygroup.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mody R, Yu AL, Naranjo A, Zhang FF, London WB, Shulkin BL, Parisi MT, Servaes SE, Diccianni MB, Hank JA, Felder M, Birstler J, Sondel PM, Asgharzadeh S, Glade-Bender J, Katzenstein H, Maris JM, Park JR, Bagatell R. Irinotecan, Temozolomide, and Dinutuximab With GM-CSF in Children With Refractory or Relapsed Neuroblastoma: A Report From the Children's Oncology Group. J Clin Oncol. 2020 Jul 1;38(19):2160-2169. doi: 10.1200/JCO.20.00203. Epub 2020 Apr 28.

Mody R, Naranjo A, Van Ryn C, Yu AL, London WB, Shulkin BL, Parisi MT, Servaes SE, Diccianni MB, Sondel PM, Bender JG, Maris JM, Park JR, Bagatell R. Irinotecan-temozolomide with temsirolimus or dinutuximab in children with refractory or relapsed neuroblastoma (COG ANBL1221): an open-label, randomised, phase 2 trial. Lancet Oncol. 2017 Jul;18(7):946-957. doi: 10.1016/S1470-2045(17)30355-8. Epub 2017 May 23.

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT01767194
• Other Study ID Numbers: NCI-2012-03125; NCI-2012-03125 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); CDR0000745188; ANBL1221; COG-ANBL1221; PANBL1221_A08PAMDREVW01; ANBL1221 ( Other Identifier: Children's Oncology Group ); ANBL1221 ( Other Identifier: CTEP ); U10CA180886 ( U.S. NIH Grant/Contract ); U10CA098543 ( U.S. NIH Grant/Contract )
• First Submitted: January 9, 2013
• First Posted: January 14, 2013
• Results First Submitted: June 24, 2019
• Results First Posted: November 18, 2019
• Last Update Posted: October 24, 2022