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

NCT00354107 | Terminated Phase 1 Results DMC

• 5 other identifiers: NCI-2009-00407COG-ANHL06P1CDR0000486425ANHL06P1U10CA098543
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anaplastic Large Cell Lymphoma; Recurrent Childhood Anaplastic Large Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 4

Secondary Outcomes (4)

• Pharmacokinetics of Monoclonal Antibody SGN-30 Assessed by Enzyme-linked Immunosorbent Assay (ELISA) Methods

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

• CD30 Concentrations Levels as Assessed by ELISA

  At baseline

• Development of Human Antichimeric Antibodies by Using ELISA Method

  Change from baseline to week 11

• Minimal Residual Disease by Using Southern Blotting or by Real-time Polymerase Chain Reaction (PCR)

  At baseline and weeks 5 and 11

Study Arms (1)

Treatment (monoclonal antibody therapy, chemotherapy)

EXPERIMENTAL

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

Interventions

monoclonal antibody SGN-30 BIOLOGICAL

Given IV

Also known as: SGN-30

Treatment (monoclonal antibody therapy, chemotherapy)

therapeutic hydrocortisone DRUG

Given IT

Also known as: Aeroseb-HC, Barseb HC, Cetacort, Cort-Dome, Cortef

Treatment (monoclonal antibody therapy, chemotherapy)

ifosfamide DRUG

Given IV

Also known as: Cyfos, Holoxan, IFF, IFX, IPP

Treatment (monoclonal antibody therapy, chemotherapy)

carboplatin DRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin

Treatment (monoclonal antibody therapy, chemotherapy)

etoposide DRUG

Given IV

Also known as: EPEG, VP-16, VP-16-213

Treatment (monoclonal antibody therapy, chemotherapy)

methotrexate DRUG

Given IT

Also known as: amethopterin, Folex, methylaminopterin, Mexate, MTX

Treatment (monoclonal antibody therapy, chemotherapy)

cytarabine DRUG

Given IT

Also known as: ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U, cytosine arabinoside

Treatment (monoclonal antibody therapy, chemotherapy)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (monoclonal antibody therapy, chemotherapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (monoclonal antibody therapy, chemotherapy)

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Histologically confirmed anaplastic large cell lymphoma
• CD30-positive disease
• Must be in first or second relapse
• Measurable disease
• No CNS disease
• Karnofsky performance status (PS) 60-100% (\> 16 years of age) OR Lansky PS 60-100% (≤ 16 years of age)
• Absolute neutrophil count ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³ (transfusion independent)
• Platelet count ≥ 20,000/mm³ if bone marrow involvement (platelet transfusions allowed)
• Hemoglobin ≥ 8.0 g/dL (RBC transfusion independent, unless bone marrow involvement)
• Creatinine adjusted according to age as follows:
• No greater than 0.4 mg/dL (≤ 5 months)
• No greater than 0.5 mg/dL (6 months-11 months)
• No greater than 0.6 mg/dL (1 year-23 months)
• No greater than 0.8 mg/dL (2 years-5 years)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Children's Oncology Group

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Lymphoma, Large-Cell, Anaplastic

Interventions

SGN-30 monoclonal antibody; Brentuximab Vedotin; Hydrocortisone; Ifosfamide; indolepropanol phosphate; Carboplatin; Etoposide; Methotrexate; merphos; Cytarabine

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Glucosides; Glycosides; Carbohydrates; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

Number of participants analyzed = 4. One patient was not evaluable for response. The Secondary Outcome measures will never be reported as data were not collected to assess these study aims.

Results Point of Contact

• Title: Results Reporting Coordinator
• Organization: Children's Oncology Group

resultsreportingcoordinator@childrensoncologygroup.org

3522730558

Study Officials

• John Sandlund

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2006
• First Posted: July 20, 2006
• Study Start: January 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: March 14, 2018
• Results First Posted: January 1, 2014

Record last verified: 2018-02

Locations

US (1)