Safety and Efficacy Study of DCVax-Direct in Solid Tumors

This study is currently recruiting participants.
Verified March 2014 by Northwest Biotherapeutics
Sponsor:
Information provided by (Responsible Party):
Northwest Biotherapeutics
ClinicalTrials.gov Identifier:
NCT01882946
First received: June 14, 2013
Last updated: March 18, 2014
Last verified: March 2014
  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: June 2015 (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
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 60 or higher or Eastern Cooperative Oncology Group (ECOG) 0-2 at screening.
  • Patients with a histological or cytopathological confirmed diagnosis of a locally advanced or metastatic solid tumor malignancy for which standard treatment is no longer effective or does not offer curative or life-prolonging potential per clinician judgment.
  • Not eligible for complete resection due to either, tumor location, physician's assessment or patient's choice.
  • Must have completed at least one and no more than four treatment regimens in the metastatic or advanced setting in the disease currently under treatment to reduce tumor burden. Treatment must have been discontinued at least 14 days prior to initiating leukapheresis.
  • 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 adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01882946

Locations
United States, Florida
MD Anderson Cancer Center Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Mollie Geismer, RN, PhD, CCRP       Mollie.Geismer@orlandohealth.com   
Principal Investigator: Omar Kayaleh, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Babita Saigal, MD    713-745-8618    bsaigal@mdanderson.org   
Contact: Patient Access Center    713-792-1160      
Principal Investigator: Vivek Subbiah, MD         
Sponsors and Collaborators
Northwest Biotherapeutics
Investigators
Study Director: Marnix Bosch, MBA, PhD Northwest Biotherapeutics
  More Information

No publications provided

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: March 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Liver Neoplasms
Melanoma
Pancreatic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014