Safety and Efficacy Study of DCVax-Direct in Solid Tumors

• ClinicalTrials.gov Identifier: NCT01882946
• Recruitment Status: Unknown
• First Posted: June 21, 2013
• Last Update Posted: October 7, 2015
• Sponsor: Northwest Biotherapeutics
• Information provided by (Responsible Party): Northwest Biotherapeutics

Tracking Information

• First Submitted Date: June 14, 2013
• First Posted Date: June 21, 2013
• Last Update Posted Date: October 7, 2015
• Study Start Date: June 2013
• Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 20, 2013): Number of patients with adverse events [ Time Frame: 6 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: June 20, 2013): Number of patients with tumor response [ Time Frame: 18 months ]
• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: June 20, 2013)

• Number of patients surviving [ Time Frame: 24 months ]
• Number of patients surviving without tumor progression [ Time Frame: 24 months ]

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Safety and Efficacy Study of DCVax-Direct in Solid Tumors
• Official Title: A PHASE I/II CLINICAL TRIAL EVALUATING DCVax-Direct, AUTOLOGOUS ACTIVATED DENDRITIC CELLS FOR INTRATUMORAL INJECTION, IN PATIENTS WITH SOLID TUMORS
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Locally Advanced Tumor
• Metastatic Solid Tissue Tumors
• Liver Cancer
• Colorectal Cancer
• Pancreatic Cancer
• Melanoma

Intervention

Biological: DCVax-Direct

Autologous, activated dendritic cells for intratumoral injection

Study Arms

Experimental: DCVax-Direct

DCVax-Direct: autologous, activated dendritic cells for intratumoral injection

Intervention: Biological: DCVax-Direct

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 20, 2013): 60
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria (summary):

• 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.

Exclusion Criteria (Summary):

• 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.
• Inability or unwillingness to return for required visits and follow-up exams.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01882946
• Other Study ID Numbers: NWBio 050012
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Northwest Biotherapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: Northwest Biotherapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Marnix Bosch, MBA, PhD; Northwest Biotherapeutics

• PRS Account: Northwest Biotherapeutics
• Verification Date: October 2015