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Safety and Efficacy Study of DCVax-Direct in Solid Tumors

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by Northwest Biotherapeutics.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01882946
First Posted: June 21, 2013
Last Update Posted: October 7, 2015
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.
Information provided by (Responsible Party):
Northwest Biotherapeutics
  Purpose
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 Intervention Phase
Locally Advanced Tumor Metastatic Solid Tissue Tumors Liver Cancer Colorectal Cancer Pancreatic Cancer Melanoma Biological: DCVax-Direct Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE I/II CLINICAL TRIAL EVALUATING DCVax-Direct, AUTOLOGOUS ACTIVATED DENDRITIC CELLS FOR INTRATUMORAL INJECTION, IN PATIENTS WITH SOLID TUMORS

Further study details as provided by Northwest Biotherapeutics:

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

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

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

Estimated Enrollment: 60
Study Start Date: June 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DCVax-Direct
DCVax-Direct: autologous, activated dendritic cells for intratumoral injection
Biological: DCVax-Direct
Autologous, activated dendritic cells for intratumoral injection

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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): NCT01882946


Locations
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
Investigators
Study Director: Marnix Bosch, MBA, PhD Northwest Biotherapeutics
  More Information

Responsible Party: Northwest Biotherapeutics
ClinicalTrials.gov Identifier: NCT01882946     History of Changes
Other Study ID Numbers: NWBio 050012
First Submitted: June 14, 2013
First Posted: June 21, 2013
Last Update Posted: October 7, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Pancreatic Neoplasms
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Liver Diseases