Safety and Efficacy Study of DCVax-Direct in Solid Tumors

Colorectal Cancer Clinical Trial

Official title:

A PHASE I/II CLINICAL TRIAL EVALUATING DCVax-Direct, AUTOLOGOUS ACTIVATED DENDRITIC CELLS FOR INTRATUMORAL INJECTION, IN PATIENTS WITH SOLID TUMORS

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01882946
• Other study ID #: NWBio 050012
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: June 14, 2013
• Last updated: October 6, 2015
• Start date: June 2013

Study information

• Verified date: October 2015
• Source: Northwest Biotherapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Biological:
• DCVax-Direct
Autologous, activated dendritic cells for intratumoral injection

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas
United States	Orlando Health	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Northwest Biotherapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients surviving		24 months	No
Other	Number of patients surviving without tumor progression		24 months	No
Primary	Number of patients with adverse events		6 months	Yes
Secondary	Number of patients with tumor response		18 months	No