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Safety and Efficacy Study of DCVax-Direct in Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01882946
Recruitment Status : Unknown
Verified October 2015 by Northwest Biotherapeutics.
Recruitment status was:  Active, not recruiting
First Posted : June 21, 2013
Last Update Posted : October 7, 2015
Information provided by (Responsible Party):
Northwest Biotherapeutics

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.

Condition or disease Intervention/treatment Phase
Locally Advanced Tumor Metastatic Solid Tissue Tumors Liver Cancer Colorectal Cancer Pancreatic Cancer Melanoma Biological: DCVax-Direct Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2013
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arm Intervention/treatment
Experimental: DCVax-Direct
DCVax-Direct: autologous, activated dendritic cells for intratumoral injection
Biological: DCVax-Direct
Autologous, activated dendritic cells for intratumoral injection

Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Number of patients with tumor response [ Time Frame: 18 months ]

Other Outcome Measures:
  1. Number of patients surviving [ Time Frame: 24 months ]
  2. Number of patients surviving without tumor progression [ Time Frame: 24 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01882946

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United States, Florida
Orlando Health
Orlando, Florida, United States, 32806
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Northwest Biotherapeutics
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Study Director: Marnix Bosch, MBA, PhD Northwest Biotherapeutics
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Responsible Party: Northwest Biotherapeutics Identifier: NCT01882946    
Other Study ID Numbers: NWBio 050012
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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