Denileukin Diftitox Followed by Vaccine Therapy in Treating Patients With Metastatic Cancer
NCT ID: NCT00128622
Last Updated: 2012-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2005-09-30
2009-05-31
Brief Summary
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PURPOSE: This phase I trial is studying the side effects of giving denileukin diftitox together with vaccine therapy in treating patients with metastatic cancer that expresses carcinoembryonic antigen.
Detailed Description
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Primary
* Determine the safety and feasibility of two different schedules of denileukin diftitox followed by active immunotherapy comprising autologous dendritic cells infected with recombinant fowlpox-CEA(6D)-TRICOM vaccine in patients with metastatic CEA-expressing malignancies.
Secondary
* Determine the immune response to this regimen in these patients.
* Determine, preliminarily, clinical response rate and/or time to progression in patients with assessable disease treated with this regimen.
OUTLINE: Patients undergo leukapheresis for collection of peripheral blood mononuclear cells (PBMCs). PBMCs are cultured with sargramostim (GM-CSF) and interleukin-4 for the production of dendritic cells( DC). DC are mixed with recombinant fowlpox-TRICOM to produce the vaccine. Patients are assigned to 1 of 2 cohorts according to timing of study enrollment.
* Cohort 1: Patients receive denileukin diftitox IV over at least 15 minutes once in week 0 and vaccine therapy comprising autologous DC infected with recombinant fowlpox-CEA (6D)-TRICOM vaccine intradermally and subcutaneously once in weeks 0 (beginning 4 days after the denileukin diftitox infusion), 3, 6, and 9. If \< 2 of 6 patients experience dose-limiting toxicity, a second cohort of patients is enrolled.
* Cohort 2: Patients receive denileukin diftitox as in cohort 1 once in weeks 0, 3, 6, and 9 and vaccine as in cohort 1.
In both cohorts, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed annually for up to 15 years.
PROJECTED ACCRUAL: A total of 6-12 patients (6 per cohort) will be accrued for this study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Denileukin Diftitox plus vaccine
This is a single arm Phase I safety study.
denileukin diftitox
recombinant fowlpox-CEA(6D)/TRICOM vaccine
therapeutic autologous dendritic cells
Interventions
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denileukin diftitox
recombinant fowlpox-CEA(6D)/TRICOM vaccine
therapeutic autologous dendritic cells
Eligibility Criteria
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Inclusion Criteria
* No history of allergies to eggs or any component of the study vaccine, denileukin diftitox, or diphtheria toxin NOTE: \*Patients with a positive anti-nuclear antibody (ANA) ≤ 1:256 with no other evidence of autoimmune disease are eligible
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 4 months after completion of study treatment
* No acute or chronic skin disorder that would preclude study treatment
* No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer
* No psychological or medical impediment that would preclude study compliance
* No other serious acute or chronic illness that would preclude study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* Prior vaccine, dendritic cell, or CEA-targeted immunotherapy allowed
* At least 4 weeks since prior and no other concurrent immunotherapy
* Concurrent palliative single-agent trastuzumab for breast cancer allowed provided patient has been on therapy for ≥ 3 months before study entry
Chemotherapy
* See Disease Characteristics
* At least 4 weeks since prior and no concurrent chemotherapy
Endocrine therapy
* At least 4 weeks since prior hormonal therapy
* At least 6 weeks since prior steroid therapy except steroids used as premedication for chemotherapy or contrast-enhanced studies
* No concurrent steroids, including corticosteroids administered to manage toxic effects from dendritic cell or denileukin diftitox administration
* Concurrent palliative endocrine therapy for breast cancer allowed provided patient has been on therapy for ≥ 3 months before study entry
Radiotherapy
* At least 4 weeks since prior and no concurrent radiotherapy
Surgery
* See Disease Characteristics
Other
* Recovered from all prior therapy
* At least 4 weeks since prior investigational drugs or procedures
* At least 4 weeks since other prior therapy
* No other concurrent immunosuppressive therapy (e.g., azathioprine or cyclosporine)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
H. Kim Lyerly
OTHER
Responsible Party
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H. Kim Lyerly
Professor, Gen & Thor Surgery
Principal Investigators
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Michael A. Morse, MD
Role: STUDY_CHAIR
Duke Cancer Institute
Locations
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Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Countries
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References
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Schonfeld K, Mahnke K, Schallenberg S, et al.: Treatment of melanoma bearing individuals with ONTAK® depletes regulatory T cells resulting in an augmented immune response following vaccination. [Abstract] J Invest Dermatol 126 (Suppl S3): A-594, s101, 2006.
Morse MA, Hobeika AC, Osada T, Serra D, Niedzwiecki D, Lyerly HK, Clay TM. Depletion of human regulatory T cells specifically enhances antigen-specific immune responses to cancer vaccines. Blood. 2008 Aug 1;112(3):610-8. doi: 10.1182/blood-2008-01-135319. Epub 2008 Jun 2.
Other Identifiers
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DUMC-NCI-7042
Identifier Type: -
Identifier Source: secondary_id
NCI-7042
Identifier Type: -
Identifier Source: secondary_id
CDR0000437795
Identifier Type: -
Identifier Source: org_study_id