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Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation

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ClinicalTrials.gov Identifier: NCT01251952
Recruitment Status : Terminated (Drug unavailable)
First Posted : December 2, 2010
Results First Posted : December 16, 2013
Last Update Posted : June 20, 2017
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Zaid Al-Kadhimi, Barbara Ann Karmanos Cancer Institute

Study Description
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Brief Summary:

The primary goal of this study is to determine the feasibility and safety of giving two doses of denileukin diftitox (DD) at days 0 and 21 post autologous stem cell transplantation in a dose escalation fashion. Secondary goals include evaluating the the effect of DD on the number and percentage of T-regs in the peripheral blood post transplant at each dose level, the effect of DD on T cell (CD4/CD8) reconstitution post transplant at each dose level and determining the time to engraftment: absolute neutrophil count (>0.5 x 10^9/L for 3 consecutive days), and platelet (>20X 10^9/L for 3 consecutive days).

The hypothesis for the study is based on the ability of DD to deplete T-regs and subsequently enhance the immune reconstitution and reverse post transplant lymphopenia. This may indirectly enhance the efficacy of autologous transplantation and reduce disease relapse.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Denileukin Diftitox (Ontak) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation.
Study Start Date : November 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : May 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Denileukin Diftitox (Ontak)
Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.
 Drug: Denileukin Diftitox (Ontak)

After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.

Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360.

Other Name: Ontak®


Outcome Measures
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Primary Outcome Measures :
  1. Assess Toxicities of Giving Two Doses of Ontak at Days 0 and 21 Post Autologous Stem Cell Transplantation in a Dose Escalation Fashion. [ Time Frame: Up to 21 days post transplant ]
    After drug infusion, participants will be closely monitored for at least 4 hours for side effects


Secondary Outcome Measures :
  1. To Evaluate the Effect of Ontak on the Number and Percentage of Regulatory T Cells in the Peripheral Blood Post Transplant at Each Dose Level. [ Time Frame: days 0 and 21 post autologous stem cell transplantation ]
  2. To Evaluate the Effect of Ontak on T Cell CD4/CD8 Reconstitution Post Transplant at Each Dose. [ Time Frame: days 0 and 21 post autologous stem cell transplantation ]
  3. To Evaluate the Effect of Ontak on Engraftment of Neutrophils and Platelets Post Transplant at Each Dose. [ Time Frame: days 0 and 21 post autologous stem cell transplantation ]
    During hospitalization stay (approximately 2 weeks), participants will receive injections of G-CSF on a daily basis starting on Day 6 and ending when white blood cells have engrafted. Participants usually remain hospitalized until engraftment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All patients age > =18 who have been diagnosed with Multiple Myeloma and are scheduled for autologous peripheral blood hematopoietic stem cell transplant (AHSCT) will be screened for eligibility.

Patients must fulfill all of the following inclusion criteria to be eligible for this study:

  1. Diagnosis of Multiple Myeloma
  2. Age >=18 and no more than 70 years.
  3. Able to understand and sign a consent form.
  4. Can collect peripheral blood stem cells with a CD34+ cell dose of at least 5.0 x 106/kg. The CD34 molecule is a Cluster of Differentiation molecule present on hematopoietic stem cells.
  5. Conditioning regimen to be high dose Melphalan at a dose of 200mg/m2.
  6. Karnofsky Performance Score (KPS) >60 or ECOG (Eastern Cooperative Oncology Group) performance status <=2
  7. Kidney function:Creatinine <2.0 mg/dl or creatinine clearance >50 ml/min
  8. Heart function: Ejection fraction >45%
  9. Liver function tests :Serum bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST) less than 3 X upper limit of normal
  10. Lung function tests: Forced Vital Capacity (FVC), Forced Expiratory Volume in One Second (FEV1) or Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) >45% predicted

Exclusion Criteria:

  1. Age <18 years or > 70 years
  2. Previous exposure to denileukin diftitox.
  3. Patients with documented uncontrolled central nervous system (CNS) disease.
  4. Previous AHSCT.
  5. Significant organ dysfunction deemed to be inappropriate for autologous transplantation.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01251952


Locations
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United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Eisai Inc.
Investigators
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Principal Investigator: Zaid Al-Kadhimi, M.D. Barbara Ann Karmanos Cancer Institute
More Information
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Responsible Party: Zaid Al-Kadhimi, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT01251952    
Other Study ID Numbers: WSU 2010-039
First Posted: December 2, 2010    Key Record Dates
Results First Posted: December 16, 2013
Last Update Posted: June 20, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
 Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Denileukin diftitox
Antineoplastic Agents