A Phase 1/2 interventional study of monoclonal antibody SGN-30 and therapeutic hydrocortisone in Anaplastic Large Cell Lymphoma and Recurrent Childhood Anaplastic Large Cell Lymphoma, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Open to participants aged 1 Year to 21 Years. Per ClinicalTrials.gov, last updated 2018-03-14.
Sponsored by National Cancer Institute (NCI) · Phase 1/2, Interventional, and Treatment
This phase I/II trial is studying the side effects and best dose of SGN-30 when given together with ifosfamide, carboplatin, and etoposide and to see how well they work in treating young patients with recurrent anaplastic large cell lymphoma. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as SGN-30, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.
PRIMARY OBJECTIVES:
I. Define and describe the toxicities of monoclonal antibody SGN-30 alone (window) and in combination with ifosfamide, carboplatin, and etoposide (ICE) in pediatric patients with CD30-positive recurrent anaplastic large cell lymphoma.
II. Define, preliminarily, the antitumor activity of monoclonal antibody SGN-30 alone (window) and in combination with ICE in these patients.
SECONDARY OBJECTIVES:
I. Characterize the pharmacokinetics of monoclonal antibody SGN-30 in these patients.
II. Characterize the soluble CD30 concentrations at time of relapse in these patients.
III. Characterize the development of human antichimeric antibodies in these patients.
IV. Measure minimal residual disease in these patients.
OUTLINE: This is a multicenter, pilot, phase I, dose-finding study of monoclonal antibody SGN-30 followed by a phase II study.
Patients receive monoclonal antibody SGN-30 IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV over 2 hours on days 1-3, carboplatin IV over 1 hour on day 1, and etoposide IV 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 comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).
NOTE: **Patients planning to undergo bone marrow transplantation (BMT) receive 2 courses of ICE only and then undergo BMT off study.
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 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.
After completion of study treatment, patients are followed periodically for 5 years.
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This study's enrollment of 5 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
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Inclusion Criteria:
Platelet count ≥ 100,000/mm³ (transfusion independent)
Creatinine adjusted according to age as follows:
Patients receive monoclonal antibody SGN-30 IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV over 2 hours on days 1-3, carboplatin IV over 1 hour on day 1, and etoposide IV 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 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 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.
Biological: monoclonal antibody SGN-30 · Drug: therapeutic hydrocortisone · Drug: ifosfamide · Drug: carboplatin · Drug: etoposide · Drug: methotrexate · Drug: cytarabine · Other: pharmacological study · Other: laboratory biomarker analysis
Given IV
Also known as: SGN-30
Given IT
Also known as: Aeroseb-HC, Barseb HC, Cetacort, Cort-Dome, Cortef
Given IV
Also known as: Cyfos, Holoxan, IFF, IFX, IPP
Given IV
Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Given IV
Also known as: EPEG, VP-16, VP-16-213
Given IT
Also known as: amethopterin, Folex, methylaminopterin, Mexate, MTX
Given IT
Also known as: ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U, cytosine arabinoside
Correlative studies
Also known as: pharmacological studies
Correlative studies
Response
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.
Time frame: Week 4
Pharmacokinetics of Monoclonal Antibody SGN-30 Assessed by Enzyme-linked Immunosorbent Assay (ELISA) Methods
Time frame: At baseline, at weeks 1, 2, 5, 6, and 11
CD30 Concentrations Levels as Assessed by ELISA
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.
Time frame: At baseline
Development of Human Antichimeric Antibodies by Using ELISA Method
Change in level from baseline to week 11 will be summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals.
Time frame: Change from baseline to week 11
Minimal Residual Disease by Using Southern Blotting or by Real-time Polymerase Chain Reaction (PCR)
NPM-ALK expression will be summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals.
Time frame: At baseline and weeks 5 and 11
| Milestone | Treatment (Monoclonal Antibody Therapy, Chemotherapy) |
|---|---|
| Started | 5 |
| Completed | 0 |
| Not completed | 5 |
| Withdrew: Adverse event | 2 |
| Withdrew: Physician decision | 2 |
| Withdrew: Withdrawal by subject | 1 |
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.
| percent | Treatment (Monoclonal Antibody Therapy, Chemotherapy) |
|---|---|
| Response | 50 |
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Change in level from baseline to week 11 will be summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals.
No measurements were reported for this outcome.
NPM-ALK expression will be summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Monoclonal Antibody Therapy, Chemotherapy) | — | 1/5 (20%) | 3/5 (60%) |
| Event | Treatment (Monoclonal Antibody Therapy, Chemotherapy) |
|---|---|
| AscitesGastrointestinal disorders | 1/5 |
| Neutrophil count decreasedInvestigations | 1/5 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 1/5 |
| Skin and subcutaneous tissue disorders - Other, specifySkin and subcutaneous tissue disorders | 1/5 |
| Capillary leak syndromeVascular disorders | 1/5 |
| Event | Treatment (Monoclonal Antibody Therapy, Chemotherapy) |
|---|---|
| AnemiaBlood and lymphatic system disorders | 3/5 |
| Alanine aminotransferase increasedInvestigations | 2/5 |
| Platelet count decreasedInvestigations | 2/5 |
| White blood cell decreasedInvestigations | 2/5 |
| HyperglycemiaMetabolism and nutrition disorders | 2/5 |
| HypoalbuminemiaMetabolism and nutrition disorders | 2/5 |
| HypokalemiaMetabolism and nutrition disorders | 2/5 |
| HypomagnesemiaMetabolism and nutrition disorders | 2/5 |
| Mucositis oralGastrointestinal disorders | 1/5 |
| Infections and infestations - Other, specifyInfections and infestations | 1/5 |
| Age, Categorical(Participants) | Treatment (Monoclonal Antibody Therapy, Chemotherapy) |
|---|---|
| <=18 years | 5 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(days) | Treatment (Monoclonal Antibody Therapy, Chemotherapy) |
|---|---|
| Median | 5655 (3157 to 5786) |
| Sex: Female, Male(Participants) | Treatment (Monoclonal Antibody Therapy, Chemotherapy) |
|---|---|
| Female | 0 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (Monoclonal Antibody Therapy, Chemotherapy) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 5 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment (Monoclonal Antibody Therapy, Chemotherapy) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Treatment (Monoclonal Antibody Therapy, Chemotherapy) |
|---|---|
| United States | 4 |
| Jordan | 1 |
This study is terminated, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)