Trial Outcomes & Findings for Ifosfamide, Carboplatin, Etoposide, and SGN-30 in Treating Young Patients With Recurrent Anaplastic Large Cell Lymphoma (NCT NCT00354107)

Last Updated: 2018-03-14

Results Overview

Anti tumor activity as assessed by computed tomography of neck/chest/abdomen/pelvis, positron emission tomography scan and/or gallium scan. Assessed by physical examination appropriate imaging studies. Bone marrow aspirate/biopsy must be normal and any macroscopic nodules in any organs detectable on imaging techniques should no longer be present. Gallium scans must be negative if initially positive.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Week 4

Results posted on

2018-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Monoclonal Antibody Therapy, Chemotherapy) Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses\\ in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5). Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study.
Overall Study STARTED	5
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Monoclonal Antibody Therapy, Chemotherapy) Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses\\ in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5). Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study.
Overall Study Adverse Event	2
Overall Study Physician Decision	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Ifosfamide, Carboplatin, Etoposide, and SGN-30 in Treating Young Patients With Recurrent Anaplastic Large Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Monoclonal Antibody Therapy, Chemotherapy) n=5 Participants Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses\\ in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5). Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study.
Age, Categorical <=18 years	5 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	5655 days n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 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	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants
Region of Enrollment Jordan	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4

Outcome measures

Outcome measures
Measure	Treatment (Monoclonal Antibody Therapy, Chemotherapy) n=4 Participants Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses\\ in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5). Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study.
Response	50 percent

SECONDARY outcome

Timeframe: At baseline, at weeks 1, 2, 5, 6, and 11

Population: These data were not collected to assess this study aim and will never be reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline

Population: These data were not collected to assess this study aim and will never be reported.

Summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals. Although the limited sample size precludes formal hypothesis testing, exploratory analysis of the association between soluble CD30 levels and PK parameters and response will be performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to week 11

Population: These data were not collected to assess this study aim and will never be reported.

Change in level from baseline to week 11 will be summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline and weeks 5 and 11

Population: These data were not collected to assess this study aim and will never be collected.

NPM-ALK expression will be summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Monoclonal Antibody Therapy, Chemotherapy)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Monoclonal Antibody Therapy, Chemotherapy) n=5 participants at risk Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses\\ in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5). Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study.
Gastrointestinal disorders Ascites	20.0% 1/5 • Number of events 1
Investigations Neutrophil count decreased	20.0% 1/5 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pleural effusion	20.0% 1/5 • Number of events 1
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	20.0% 1/5 • Number of events 1
Vascular disorders Capillary leak syndrome	20.0% 1/5 • Number of events 1

Other adverse events

Other adverse events
Measure	Treatment (Monoclonal Antibody Therapy, Chemotherapy) n=5 participants at risk Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses\\ in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5). Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study.
Blood and lymphatic system disorders Anemia	60.0% 3/5 • Number of events 3
Gastrointestinal disorders Mucositis oral	20.0% 1/5 • Number of events 1
Infections and infestations Infections and infestations - Other, specify	20.0% 1/5 • Number of events 1
Investigations Alanine aminotransferase increased	40.0% 2/5 • Number of events 2
Investigations Aspartate aminotransferase increased	20.0% 1/5 • Number of events 1
Investigations Blood bilirubin increased	20.0% 1/5 • Number of events 1
Investigations Neutrophil count decreased	20.0% 1/5 • Number of events 1
Investigations Platelet count decreased	40.0% 2/5 • Number of events 2
Investigations White blood cell decreased	40.0% 2/5 • Number of events 2
Metabolism and nutrition disorders Hypercalcemia	20.0% 1/5 • Number of events 1
Metabolism and nutrition disorders Hyperglycemia	40.0% 2/5 • Number of events 2
Metabolism and nutrition disorders Hypoalbuminemia	40.0% 2/5 • Number of events 2
Metabolism and nutrition disorders Hypocalcemia	20.0% 1/5 • Number of events 1
Metabolism and nutrition disorders Hypokalemia	40.0% 2/5 • Number of events 2
Metabolism and nutrition disorders Hypomagnesemia	40.0% 2/5 • Number of events 2
Metabolism and nutrition disorders Hyponatremia	20.0% 1/5 • Number of events 1
Metabolism and nutrition disorders Hypophosphatemia	20.0% 1/5 • Number of events 1

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 3522730558

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60