Denileukine Diftitox for Relapsed ALCL

NCT00801918 | Withdrawn Phase 2 DMC

• 1 other identifier: AAAC8963
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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, 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).

Conditions

Anaplastic Large-Cell Lymphoma

Keywords

lymphoma; pediatric; adolescent; relapsed; refractory; denileukin diftitox; Ontak

Outcome Measures

Primary Outcomes (3)

• Toxicity

  5 months

• Determine response rate

  6 months

• Evaluate safety of combination of Denileukin Diftitox and ICE chemotherapy

  6 months

Secondary Outcomes (1)

• Biology Studies of ALCL

  6 months

Study Arms (2)

DD Alone

OTHER

Patients will get Denileukin Diftitox for 5 days every 3 weeks for a total of 4 cycles.

Drug: Denileukin Diftitox

DD with ICE Chemotherapy

EXPERIMENTAL

For patients who show a response to DD alone after 4 cycles or for patients who show progressive disease after 2 cycles, DD will be given with ICE chemotherapy for 2 cycles.

Drug: Denileukin diftitox, ifosfamide, cyclophosphamide, etoposide

Interventions

Denileukin Diftitox DRUG

Denileukin Diftitox: 18 mcg/kg/day: days 1-5 in cycles 1,2,3,4

Also known as: Ontak

DD Alone

Denileukin diftitox, ifosfamide, cyclophosphamide, etoposide DRUG

Denileukin Diftitox: 18 mcg/kg/day days 1-2 in cycles 5 and 6 Ifosfamide: 3000mg/m²/IV/d X 3 days + Mesna 3000 mg/m2/d X 3 days Carboplatin: 635mg/m2/d X 1 day Etoposide: 100mg/m2/d X 3 days

Also known as: Ontak

DD with ICE Chemotherapy

Eligibility Criteria

• Age: 2 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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:

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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Lymphoma, Large-Cell, Anaplastic; Lymphoma; Recurrence

Interventions

denileukin diftitox; Ifosfamide; Cyclophosphamide; Etoposide

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Mitchell S Cairo, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 3, 2008
• First Posted: December 4, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: May 15, 2013

Record last verified: 2009-10

Locations

US (1)