Ifosfamide, Carboplatin, Etoposide, and SGN-30 in Treating Young Patients With Recurrent Anaplastic Large Cell Lymphoma
Stopped early · Phase 1/Phase 2
Conditions studied: Anaplastic Large Cell Lymphoma, Recurrent Childhood Anaplastic Large Cell Lymphoma
In brief
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.
Key facts
- Study ID
- NCT00354107
- Run by
- National Cancer Institute (NCI)
- People needed
- 5
- Starts
- 2007-01-01
- Expected to finish
- 2010-01-01
- Last updated by the study team
- 2018-03-14
Who can join
Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
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)
- 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
Where it is running
- Children's Oncology Group — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.