Trial Outcomes & Findings for Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma (NCT NCT00077207)

Last Updated: 2018-05-16

Results Overview

Success is defined as the completion of induction plus one cycle of maintenance within 24 weeks of enrollment without more than a 25% reduction in either carboplatin or temozolomide dosage. Failure to complete the induction and one cycle of maintenance within 24 weeks counts as a short-term-feasibility failure.

Recruitment status

COMPLETED

Study phase

Target enrollment

66 participants

Primary outcome timeframe

24 weeks

Results posted on

2018-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression. carboplatin: Given IV temozolomide: Given orally vincristine sulfate: Given IV
Overall Study STARTED	66
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression. carboplatin: Given IV temozolomide: Given orally vincristine sulfate: Given IV
Overall Study Adverse Event	5
Overall Study Lack of Efficacy	12
Overall Study Physician Decision	6
Overall Study Withdrawal by Subject	6
Overall Study Ineligible	1

Baseline Characteristics

Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) n=66 Participants Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression. carboplatin: Given IV temozolomide: Given orally vincristine sulfate: Given IV
Age, Continuous	4 years n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	6 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	61 participants n=5 Participants
Region of Enrollment Canada	1 participants n=5 Participants
Region of Enrollment Australia	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Fourteen (14) patients were considered not evaluable for short-term toxicity because: ineligible - 1 patient; progression during induction - 9 patients; progression during maintenance 2 patients; parent preference - 1 patient and infection resulting in termination of protocol therapy - 1 patient.

Outcome measures

Outcome measures
Measure	Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) n=52 Participants Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression. carboplatin: Given IV temozolomide: Given orally vincristine sulfate: Given IV
Short Term Feasibility Success	25 participants

PRIMARY outcome

Timeframe: 60 weeks

Population: Fourteen (14) patients were considered not evaluable for long-term toxicity because: ineligible - 1 patient; progression during induction - 9 patients; progression during maintenance 2 patients; parent preference - 1 patient and infection resulting in termination of protocol therapy - 1 patient.

Success is defined as the completion of induction plus four cycles of maintenance within 60 weeks of enrollment without more than a 25% reduction in either carboplatin or temozolomide dosage. If the participant completes all therapy within 60 weeks the patient is a long-term feasibility success. As such, a patient who experiences short term feasibility failure can be classified as a long-term feasibility success.

Outcome measures

Outcome measures
Measure	Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) n=52 Participants Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression. carboplatin: Given IV temozolomide: Given orally vincristine sulfate: Given IV
Long Term Feasibility Success	41 participants

SECONDARY outcome

Timeframe: Up to 6 years after the start of protocol therapy

Population: Sixty-five (65) eligible patients were enrolled and received protocol therapy. These patients are considered for this outcome measure.

Primary safety endpoints are (1) the occurrence of toxic death, which is death during treatment that is not primarily attributable to disease progression, and (2) the occurrence of grade 4 allergy to carboplatin.

Outcome measures

Outcome measures
Measure	Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) n=65 Participants Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression. carboplatin: Given IV temozolomide: Given orally vincristine sulfate: Given IV
Number of Participants Who Experienced Toxic Death	0 Participants

SECONDARY outcome

Timeframe: Up to 18 months of protocol therapy

Population: Sixty-five (65) eligible patients were enrolled and received protocol therapy. These patients are considered for this outcome measure.

Occurence of grade 3 or 4 thrombocytopenia or neutropenia while receiving protocol therapy.

Outcome measures

Outcome measures
Measure	Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) n=65 Participants Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression. carboplatin: Given IV temozolomide: Given orally vincristine sulfate: Given IV
Number of Participants Who Experienced a Grade 3 or 4 Thrombocytopenia and/or Neutropenia.	43 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Sixty-five (65) eligible patients were enrolled and received protocol therapy. These patients are considered for this outcome measure.

Percentage probability of being alive and without the occurrence of disease progression 3 years following enrollment.

Outcome measures

Outcome measures
Measure	Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) n=65 Participants Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression. carboplatin: Given IV temozolomide: Given orally vincristine sulfate: Given IV
Percent Probability of Progression-free Survival (PFS)	60.59 Percent probability PFS Interval 47.48 to 71.4

SECONDARY outcome

Timeframe: Six years

Population: Sixty-five (65) eligible patients were enrolled and received protocol therapy. These patients are considered for this outcome measure.

Percentage probability of being alive and without the occurrence of disease progression or second malignant neoplasm 6 years following enrollment.

Outcome measures

Outcome measures
Measure	Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) n=65 Participants Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression. carboplatin: Given IV temozolomide: Given orally vincristine sulfate: Given IV
Percentage Probability of Event-free Survival (EFS)	40.89 percent probability EFS Interval 28.63 to 52.76

SECONDARY outcome

Timeframe: Up to 18 months of protocol therapy

Population: Sixty-five (65) eligible patients were enrolled and received protocol therapy. Of these patients, 60 had data submission sufficient to determine response.

Response as complete response, partial response, stable disease, or progressive disease using three-dimensional imaging measurements (preferable) or two-dimensional imaging measurements, as well as the response in the context of multiple lesions or disseminated disease.

Outcome measures

Outcome measures
Measure	Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) n=60 Participants Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression. carboplatin: Given IV temozolomide: Given orally vincristine sulfate: Given IV
Total Number of Patients Experiencing a Response Complete response	2 Participants
Total Number of Patients Experiencing a Response Partial response	15 Participants
Total Number of Patients Experiencing a Response Stable disease	36 Participants
Total Number of Patients Experiencing a Response Progressive disease	7 Participants

Adverse Events

Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)

Serious events: 6 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) n=64 participants at risk Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression. carboplatin: Given IV temozolomide: Given orally vincristine sulfate: Given IV
Investigations Alanine aminotransferase increased	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Respiratory, thoracic and mediastinal disorders Cough	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Eye disorders Eye disorders - Other, specify	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Investigations Neutrophil count decreased	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Investigations Platelet count decreased	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Renal and urinary disorders Proteinuria	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.

Other adverse events

Other adverse events
Measure	Treatment (Carboplatin, Vincristine Sulfate, Temozolomide) n=64 participants at risk Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression. carboplatin: Given IV temozolomide: Given orally vincristine sulfate: Given IV
Gastrointestinal disorders Abdominal distension	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Gastrointestinal disorders Abdominal pain	15.6% 10/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Metabolism and nutrition disorders Acidosis	15.6% 10/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Psychiatric disorders Agitation	4.7% 3/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Investigations Alanine aminotransferase increased	29.7% 19/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Investigations Alkaline phosphatase increased	10.9% 7/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Immune system disorders Allergic reaction	10.9% 7/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	7.8% 5/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Skin and subcutaneous tissue disorders Alopecia	15.6% 10/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Immune system disorders Anaphylaxis	10.9% 7/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Blood and lymphatic system disorders Anemia	51.6% 33/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Metabolism and nutrition disorders Anorexia	15.6% 10/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Musculoskeletal and connective tissue disorders Arthralgia	3.1% 2/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Musculoskeletal and connective tissue disorders Arthritis	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Investigations Aspartate aminotransferase increased	32.8% 21/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Nervous system disorders Ataxia	9.4% 6/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Musculoskeletal and connective tissue disorders Back pain	4.7% 3/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Investigations Blood antidiuretic hormone abnormal	3.1% 2/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Investigations Blood bilirubin increased	4.7% 3/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Investigations Blood corticotrophin decreased	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Eye disorders Blurred vision	4.7% 3/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Respiratory, thoracic and mediastinal disorders Bronchospasm	3.1% 2/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Injury, poisoning and procedural complications Bruising	4.7% 3/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Cardiac disorders Cardiac disorders - Other, specify	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Infections and infestations Catheter related infection	3.1% 2/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Investigations Cholesterol high	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Nervous system disorders Cognitive disturbance	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Gastrointestinal disorders Constipation	25.0% 16/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Respiratory, thoracic and mediastinal disorders Cough	14.1% 9/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Investigations Creatinine increased	4.7% 3/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Endocrine disorders Cushingoid	4.7% 3/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Renal and urinary disorders Cystitis noninfective	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Metabolism and nutrition disorders Dehydration	6.2% 4/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Injury, poisoning and procedural complications Dermatitis radiation	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Gastrointestinal disorders Diarrhea	14.1% 9/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Skin and subcutaneous tissue disorders Dry skin	3.1% 2/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Gastrointestinal disorders Dysphagia	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
General disorders Edema face	3.1% 2/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Infections and infestations Enterocolitis infectious	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Infections and infestations Esophageal infection	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Eye disorders Extraocular muscle paresis	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Eye disorders Eye disorders - Other, specify	4.7% 3/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Infections and infestations Eye infection	3.1% 2/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
General disorders Facial pain	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
General disorders Fatigue	20.3% 13/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Blood and lymphatic system disorders Febrile neutropenia	15.6% 10/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
General disorders Fever	28.1% 18/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
General disorders Flu like symptoms	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
General disorders General disorders and administration site conditions - Other, specify	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Infections and infestations Gum infection	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Nervous system disorders Headache	17.2% 11/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Nervous system disorders Hydrocephalus	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Metabolism and nutrition disorders Hypercalcemia	4.7% 3/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Metabolism and nutrition disorders Hyperglycemia	35.9% 23/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Skin and subcutaneous tissue disorders Hyperhidrosis	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Metabolism and nutrition disorders Hyperkalemia	6.2% 4/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Metabolism and nutrition disorders Hypermagnesemia	14.1% 9/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Metabolism and nutrition disorders Hypernatremia	4.7% 3/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Vascular disorders Hypertension	6.2% 4/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Metabolism and nutrition disorders Hypoalbuminemia	10.9% 7/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Metabolism and nutrition disorders Hypocalcemia	14.1% 9/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Metabolism and nutrition disorders Hypoglycemia	12.5% 8/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Metabolism and nutrition disorders Hypokalemia	29.7% 19/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Metabolism and nutrition disorders Hypomagnesemia	6.2% 4/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Metabolism and nutrition disorders Hyponatremia	21.9% 14/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Metabolism and nutrition disorders Hypophosphatemia	15.6% 10/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Vascular disorders Hypotension	3.1% 2/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Gastrointestinal disorders Ileus	3.1% 2/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Infections and infestations Infections and infestations - Other, specify	17.2% 11/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Psychiatric disorders Insomnia	3.1% 2/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Injury, poisoning and procedural complications Intraoperative neurological injury	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Investigations Investigations - Other, specify	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
General disorders Irritability	4.7% 3/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Cardiac disorders Left ventricular systolic dysfunction	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Investigations Lymphocyte count decreased	26.6% 17/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Nervous system disorders Memory impairment	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Ear and labyrinth disorders Middle ear inflammation	3.1% 2/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Gastrointestinal disorders Mucositis oral	4.7% 3/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Gastrointestinal disorders Nausea	25.0% 16/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Musculoskeletal and connective tissue disorders Neck pain	3.1% 2/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Nervous system disorders Nervous system disorders - Other, specify	6.2% 4/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Investigations Neutrophil count decreased	65.6% 42/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
General disorders Non-cardiac chest pain	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Nervous system disorders Oculomotor nerve disorder	3.1% 2/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Eye disorders Optic nerve disorder	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Gastrointestinal disorders Oral pain	4.7% 3/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Infections and infestations Otitis media	4.7% 3/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
General disorders Pain	14.1% 9/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Musculoskeletal and connective tissue disorders Pain in extremity	7.8% 5/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Nervous system disorders Peripheral motor neuropathy	12.5% 8/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Nervous system disorders Peripheral sensory neuropathy	10.9% 7/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Psychiatric disorders Personality change	4.7% 3/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Infections and infestations Pharyngitis	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	3.1% 2/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Eye disorders Photophobia	3.1% 2/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Investigations Platelet count decreased	46.9% 30/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Skin and subcutaneous tissue disorders Pruritus	6.2% 4/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Skin and subcutaneous tissue disorders Purpura	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Nervous system disorders Pyramidal tract syndrome	4.7% 3/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Skin and subcutaneous tissue disorders Rash maculo-papular	12.5% 8/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Gastrointestinal disorders Rectal hemorrhage	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Renal and urinary disorders Renal and urinary disorders - Other, specify	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	6.2% 4/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Infections and infestations Rhinitis infective	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Nervous system disorders Seizure	4.7% 3/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Immune system disorders Serum sickness	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Cardiac disorders Sinus tachycardia	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Infections and infestations Sinusitis	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	4.7% 3/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Infections and infestations Skin infection	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Gastrointestinal disorders Toothache	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Nervous system disorders Tremor	7.8% 5/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Nervous system disorders Trigeminal nerve disorder	4.7% 3/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Infections and infestations Upper respiratory infection	4.7% 3/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Renal and urinary disorders Urinary frequency	3.1% 2/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Renal and urinary disorders Urinary tract pain	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Skin and subcutaneous tissue disorders Urticaria	4.7% 3/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Reproductive system and breast disorders Vaginal inflammation	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Vascular disorders Vascular disorders - Other, specify	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Respiratory, thoracic and mediastinal disorders Voice alteration	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Gastrointestinal disorders Vomiting	35.9% 23/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Eye disorders Watering eyes	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Investigations Weight gain	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Investigations Weight loss	7.8% 5/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Investigations White blood cell decreased	48.4% 31/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Injury, poisoning and procedural complications Wound dehiscence	1.6% 1/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.
Infections and infestations Wound infection	3.1% 2/64 66 patients enrolled, 64 reported for adverse events as 1 patient was ineligible and 1 patient missed a reporting period.

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 352-273-0558

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place