Trial Outcomes & Findings for Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors (NCT NCT00024258)

NCT ID: NCT00024258

Last Updated: 2015-11-25

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 22 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2015-11-25

Participant Flow

Participant milestones

Measure	Arsenic Trioxide Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-3 months for 1 year and then annually thereafter.
Overall Study STARTED	22
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Arsenic Trioxide Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-3 months for 1 year and then annually thereafter.
Overall Study Withdrawal by Subject	1
Overall Study Disease Progression	8

Baseline Characteristics

Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors

Baseline characteristics by cohort

Measure	Arsenic Trioxide n=22 Participants Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-3 months for 1 year and then annually thereafter.
Age, Categorical <=18 years	19 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Measure	Arsenic Trioxide n=21 Participants Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-3 months for 1 year and then annually thereafter.
Response Rate After Every 3 Courses During Treatment and Then Every 2-3 Months for 1 Year After Completion of Treatment Progression of Disease	16 participants
Response Rate After Every 3 Courses During Treatment and Then Every 2-3 Months for 1 Year After Completion of Treatment Stable Disease	5 participants

Adverse Events

Arsenic Trioxide

Serious events: 12 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arsenic Trioxide n=22 participants at risk Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-3 months for 1 year and then annually thereafter.
Investigations Alanine aminotransferase increased	4.5% 1/22 • Number of events 1
Investigations Aspartate aminotransferase increased	4.5% 1/22 • Number of events 1
Investigations Blood bilirubin increased	4.5% 1/22 • Number of events 1
Infections and infestations Catheter related infection	4.5% 1/22 • Number of events 1
Metabolism and nutrition disorders Dehydration	4.5% 1/22 • Number of events 1
Blood and lymphatic system disorders Febrile Neutropenia	4.5% 1/22 • Number of events 1
Blood and lymphatic system disorders Anemia	4.5% 1/22 • Number of events 1
Metabolism and nutrition disorders Hypercalcemia	4.5% 1/22 • Number of events 1
Metabolism and nutrition disorders Hyperkalemia	4.5% 1/22 • Number of events 1
Metabolism and nutrition disorders Hypocalcemia	4.5% 1/22 • Number of events 1
Infections and infestations Infection NOS	18.2% 4/22 • Number of events 4
Nervous system disorders Neuralgia	4.5% 1/22 • Number of events 1
Investigations Neutrophil count decrease	13.6% 3/22 • Number of events 4
Investigations Electrocardiogram QT corrected interval prolonged	4.5% 1/22 • Number of events 1
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify Respiratory disorder	9.1% 2/22 • Number of events 2
Renal and urinary disorders Renal failure	4.5% 1/22 • Number of events 1
Gastrointestinal disorders Vomiting	4.5% 1/22 • Number of events 1

Other adverse events

Measure	Arsenic Trioxide n=22 participants at risk Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-3 months for 1 year and then annually thereafter.
Metabolism and nutrition disorders Anorexia	9.1% 2/22 • Number of events 2
Investigations Blood bilirubin increased	4.5% 1/22 • Number of events 15
Musculoskeletal and connective tissue disorders Bone pain	18.2% 4/22 • Number of events 4
Injury, poisoning and procedural complications Bruising	4.5% 1/22 • Number of events 1
Eye disorders Conjunctivitis	4.5% 1/22 • Number of events 1
Gastrointestinal disorders Constipation	13.6% 3/22 • Number of events 3
Respiratory, thoracic and mediastinal disorders Cough	13.6% 3/22 • Number of events 4
Eye disorders Dry Eye	4.5% 1/22 • Number of events 1
Respiratory, thoracic and mediastinal disorders Dyspnea	9.1% 2/22 • Number of events 2
General disorders Edema	13.6% 3/22 • Number of events 3
General disorders Fatigue	4.5% 1/22 • Number of events 1
Blood and lymphatic system disorders Febrile Neutropenia	4.5% 1/22 • Number of events 1
General disorders Fever	9.1% 2/22 • Number of events 2
Gastrointestinal disorders Gastrointestinal other	9.1% 2/22 • Number of events 2
Blood and lymphatic system disorders Anemia	13.6% 3/22 • Number of events 3
Metabolism and nutrition disorders Hyperglycemia	4.5% 1/22 • Number of events 1
Metabolism and nutrition disorders Hypermagnesemia	4.5% 1/22 • Number of events 1
Vascular disorders Hypertension	4.5% 1/22 • Number of events 1
Infections and infestations Infection w/o neutropenia	18.2% 4/22 • Number of events 4
Investigations White blood cell decreased	4.5% 1/22 • Number of events 4
Psychiatric disorders Anxiety	9.1% 2/22 • Number of events 2
Gastrointestinal disorders Nausea	13.6% 3/22 • Number of events 3
Nervous system disorders Neurology, other	4.5% 1/22 • Number of events 1
Investigations Neutrophil count decreased	9.1% 2/22 • Number of events 6
General disorders Pain, other	13.6% 3/22 • Number of events 4
Skin and subcutaneous tissue disorders Purpura	4.5% 1/22 • Number of events 1
Investigations Platelet count decreased	9.1% 2/22 • Number of events 3
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.5% 1/22 • Number of events 1
Investigations Alanine aminotransferase increased	4.5% 1/22 • Number of events 1
Cardiac disorders Sinus tachycardia	4.5% 1/22 • Number of events 1
Gastrointestinal disorders Mucositis	4.5% 1/22 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	9.1% 2/22 • Number of events 2
Renal and urinary disorders Urinary retention	4.5% 1/22 • Number of events 1
Gastrointestinal disorders Vomiting	13.6% 3/22 • Number of events 4
Investigations Weight loss	4.5% 1/22 • Number of events 1

Additional Information

Dr. Brian Kushner

Memorial Sloan Kettering Cancer Center

Phone: 212-639-6793

Email: kushnerb@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place