Status:
TERMINATED
Ifosfamide, Carboplatin, Etoposide, and SGN-30 in Treating Young Patients With Recurrent Anaplastic Large Cell Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Anaplastic Large Cell Lymphoma
Recurrent Childhood Anaplastic Large Cell Lymphoma
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
PHASE2
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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00354107
Start Date
January 1 2007
End Date
January 1 2010
Last Update
March 14 2018
Active Locations (1)
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1
Children's Oncology Group
Philadelphia, Pennsylvania, United States, 19104