Safety and Efficacy Study of DCVax-Direct in Solid Tumors
A PHASE I/II CLINICAL TRIAL EVALUATING DCVax-Direct, AUTOLOGOUS ACTIVATED DENDRITIC CELLS FOR INTRATUMORAL INJECTION, IN PATIENTS WITH SOLID TUMORS
1 other identifier
interventional
60
1 country
2
Brief Summary
The study comprises a Phase I component during which the optimal dose of DCVax-Direct for the treatment of solid tissue tumors will be identified, followed by a Phase II component to determine if the injection of DCVax-Direct into selected solid tissue tumors has the ability to reduce tumor growth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 14, 2013
CompletedFirst Posted
Study publicly available on registry
June 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedOctober 7, 2015
October 1, 2015
3.5 years
June 14, 2013
October 6, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with adverse events
6 months
Secondary Outcomes (1)
Number of patients with tumor response
18 months
Other Outcomes (2)
Number of patients surviving
24 months
Number of patients surviving without tumor progression
24 months
Study Arms (1)
DCVax-Direct
EXPERIMENTALDCVax-Direct: autologous, activated dendritic cells for intratumoral injection
Interventions
Eligibility Criteria
You may qualify if:
- Age between 18 and 75 years (inclusive) at screening.
- Karnofsky performance status (KPS) of 70 or higher or Eastern Cooperative Oncology Group (ECOG) 0-1 at screening.
- Subjects with a histological or cytopathological confirmed diagnosis of a locally advanced or metastatic solid tumor malignancy for which primary treatment is no longer effective or does not offer curative or life-prolonging potential per clinician judgment, with the understanding that DCVax-Direct is not intended as a treatment of last resort.
- Not eligible for complete resection due to either tumor location, physician's assessment or subject's choice.
- Must have completed at least one recent treatment regimen in the metastatic or advanced setting in the disease currently under treatment to reduce tumor burden.
- Any steroid therapy \>2 mg dexamethasone or equivalent dose should be stopped or have been tapered down 2 weeks prior to the leukapheresis.
- At least one measurable tumor mass, i.e. a lesion that can accurately be measured by CT/MRI in at least one dimension with longest diameter ≥ 1 cm, that is accessible for injection either with or without imaging (CT/ultrasound) guidance.
- Adequate hematological, hepatic, and renal function,
- Adequate blood coagulation parameters
- Life expectation of \>3 months.
You may not qualify if:
- Positive HIV-1, HIV-2, or Human T-lymphotropic virus (HTLV-I/II) tests.
- History of current or prior (within the last two years) active clinically significant malignancy other than the tumor type for which DCVax-Direct treatment is considered, and except for primary tumor in the case of metastases and adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Heavily pretreated (HP) subjects are not eligible for this study, unless treatments have occurred more than 1 year in the past.
- Presence of brain metastases, unless treated surgically and/or irradiated and clinically stable off steroids or on low dose (\< 2 mg per day) steroids for ≥ 14 days, or presence of leptomeningeal disease.
- History of immunodeficiency or unresolved autoimmune disease.
- Requirement for ongoing immunosuppressants.
- Prior active immunotherapy for cancer within the past 2 years.
- Ongoing medical need for continuous anti-coagulation or anti-platelet medication.
- Known genetic cancer-susceptibility syndromes.
- Acute or active uncontrolled infection
- Ongoing fever ≥ 101.5 degrees F/38.6 degrees C at screening.
- Unstable or severe intercurrent medical conditions such as unstable angina, uncontrolled arrhythmias, Crohn's Disease, ulcerative colitis etc.
- Females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception (surgical, hormonal or double barrier, i.e. condom and diaphragm).
- Allergy or anaphylaxis to any of the reagents used in this study.
- Inability to obtain informed consent because of psychiatric or complicating medical problems.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Orlando Health
Orlando, Florida, 32806, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marnix Bosch, MBA, PhD
Northwest Biotherapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2013
First Posted
June 21, 2013
Study Start
June 1, 2013
Primary Completion
December 1, 2016
Last Updated
October 7, 2015
Record last verified: 2015-10