Anaplastic Large Cell Lymphoma Clinical Trial
Official title:
A Phase I/II Pilot Study of Ifosfamide, Carboplatin and Etoposide Therapy (ICE) and SGN-30 (NSC# 731636, IND#) in Children With CD30+ Recurrent Anaplastic Large Cell Lymphoma
Verified date | February 2018 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 5 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 21 Years |
Eligibility |
Inclusion Criteria: - 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) - No greater than 1.0 mg/dL (6 years-9 years) - No greater than 1.2 mg/dL (10 years-12 years) - No greater than 1.4 mg/dL (13 years and over [female]) - No greater than 1.5 mg/dL (13 years to 15 years [male]) - No greater than 1.7 mg/dL (16 years and over [male]) - Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min - Bilirubin = 1.5 times upper limit of normal (ULN) - ALT < 3 times ULN - Albumin = 2 g/dL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for = 3 months after completion of study treatment - No evidence of graft-vs-host disease - No documented active infection requiring antibiotics - No isolated bone recurrence - Recovered from prior therapy - At least 3 months since prior monoclonal antibody therapy - At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) - At least 7 days since prior hematopoietic growth factor therapy - At least 3 months since prior biologic (antineoplastic) agents - At least 2 weeks since prior local palliative radiotherapy (small port) - At least 3 months since prior total-body irradiation, craniospinal radiotherapy, or radiotherapy to = 50% of the pelvis - At least 6 weeks since other prior substantial bone marrow irradiation - At least 2 months since prior stem cell transplantation or rescue - No prior monoclonal antibody SGN-30 - Concurrent steroids allowed provided dose has been stable or decreasing for the past 7 days - No concurrent immunosuppressive agents - No concurrent dexamethasone as an antiemetic - No other concurrent investigational drug or anticancer agents, including chemotherapy, radiotherapy, immunotherapy, or biological therapy |
Country | Name | City | State |
---|---|---|---|
United States | Children's Oncology Group | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Pharmacokinetics of Monoclonal Antibody SGN-30 Assessed by Enzyme-linked Immunosorbent Assay (ELISA) Methods | At baseline, at weeks 1, 2, 5, 6, and 11 | ||
Secondary | 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. | At baseline | |
Secondary | 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. | Change from baseline to week 11 | |
Secondary | 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. | At baseline and weeks 5 and 11 |
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