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Safety and Efficacy Study of DCVax-Direct in Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Northwest Biotherapeutics
ClinicalTrials.gov Identifier:
NCT01882946
First received: June 14, 2013
Last updated: October 6, 2015
Last verified: October 2015
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Northwest Biotherapeutics:

Primary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of patients with tumor response [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Number of patients surviving [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Number of patients surviving without tumor progression [ Time Frame: 24 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: June 14, 2013
Last Updated: October 6, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on December 09, 2016