Denileukine Diftitox for Relapsed ALCL

Withdrawn before enrolling · Phase 2

Conditions studied: Anaplastic Large-Cell Lymphoma

In brief

The purpose of this study is to determine is Denileukin diftitox will be safe, well tolerated and induce a significant overall response alone and in combination with chemotherapy: ifosfamide, carboplatin and etoposide (ICE) and will be safe and well tolerated in a population of children, adolescents and young adults with relapsed or refractory anaplastic large cell lymphoma (ALCL).

Key facts

Study ID

NCT00801918

Run by

Columbia University

People needed

0

Starts

2008-12-01

Expected to finish

2012-06-01

Last updated by the study team

2013-05-15

Who can join

Age: 2 and older, up to 24. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: Patients must be ≥ 2.00 year and ≤ 24.99 years of age at the time of study entry.
• Diagnosis:
• Patients must have previous histologic verification of anaplastic large cell lymphoma (ALCL). Patients must be in first, second or third relapse or initial induction failure.
• Disease Status: Patients must have measurable radiographic disease.
• Performance Level: Karnofsky > 60% for patients > 16 years of age and Lansky > 60 for patients <16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
• Prior Therapy
• Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. Patients who are post-allogeneic transplant should be off immunosuppressive agents prior to starting therapy. Steroid doses should also be stable or decreasing for at least 1 week prior to starting therapy.
• Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (6 weeks if prior nitrosourea).
• Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. These patients must be discussed with the Study Chair on a case-by-case basis.
• XRT: > 2 wks for local palliative XRT (small port); > 2 months must have elapsed if prior TBI, craniospinal XRT or if > 50% radiation of pelvis; > 6 wks must have elapsed if other substantial BM radiation.
• Stem Cell Transplant or Rescue: No evidence of active graft vs. host disease and > 2 months must have elapsed since SCT.
• Patients may not have received prior therapy with Denileukin Diftitox
• Organ Function Requirements
• Adequate Bone Marrow Function Defined As:
• For patients without bone marrow involvement:
• Peripheral absolute neutrophil count (ANC) > 1,000
• Platelet count > 100,000 (transfusion independent)
• Hemoglobin > 8.0 gm (RBC transfusion independent)
• For patients with bone marrow involvement:
• Peripheral absolute neutrophil count (ANC) > 1,0
• Platelet count > 20,000 (may receive platelet transfusions)
• Hemoglobin > 8.0 (may receive RBC transfusions)
• Adequate Renal Function Defined As:
• Creatinine clearance or radioisotope GFR 70mL/min/1.73m2
• OR

You may not qualify if…

• Patients must not be currently receiving another investigational drug.
• Patients must not be currently receiving other anti-cancer agents.
• Patients must have a negative pregnancy test and Nursing mothers must agree not to breast-feed.
• Patients who have a documented uncontrolled infection requiring IV antibiotics
• Patients with CNS disease are not eligible.

Where it is running

• Columbia University Medical Center — New York, New York, 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.