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

• Status: Terminated
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Monoclonal; Brentuximab Vedotin; Carboplatin; Cortisol succinate; Cytarabine; Etoposide; Etoposide phosphate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Ifosfamide; Immunoglobulins; Isophosphamide mustard; Methotrexate

Criteria

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