Status:
WITHDRAWN
Denileukine Diftitox for Relapsed ALCL
Lead Sponsor:
Columbia University
Conditions:
Anaplastic Large-Cell Lymphoma
Eligibility:
All Genders
2-24 years
Phase:
PHASE2
Brief Summary
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, carbopla...
Detailed Description
Despite significant progress in the treatment and outcome for childhood ALCL, the prognosis for children who develop progressive or recurrent disease is poor with \< 30% DFS. Novel therapies are urgen...
Eligibility Criteria
Inclusion
- 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
- A serum/plasma creatinine GFR calculation using the Schwartz formula (Schwartz et al. J. Peds, 106:522, 1985)
- Estimated Creatinine Clearance (in mL/min/1.73 m2) = (k)(L)/Pcr
- Where L = child's length in cm Pcr = plasma (or serum) creatinine (in mg/dL)
- k Values = 0.33 low birth weight infant 0.45 term infant 0.55 child 0.55 adolescent female 0.70 adolescent male
- Adequate Liver Function Defined As:
- Bilirubin (sum of conjugated + unconjugated) \< 1.5 x upper limit of normal (ULN) for age, and
- SGPT (ALT) \< 3 x upper limit of normal (ULN) for age
- Serum albumin \> 2 g/dL.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00801918
Start Date
December 1 2008
End Date
June 1 2012
Last Update
May 15 2013
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032