Locally Advanced TumorPhase 1/2NCT01882946
Safety and Efficacy Study of DCVax-Direct in Solid Tumors
A Phase 1/2 study testing DCVax-Direct in people with Locally Advanced Tumor and Metastatic Solid Tissue Tumors, run by Northwest Biotherapeutics at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Tumor, Metastatic Solid Tissue Tumors, Liver Cancer
- What is being tested?
- DCVax-Direct
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2013to Dec 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MD Anderson Cancer Center
Houston, Texas, 77030
Orlando Health
Orlando, Florida, 32806
About this study
Official title: A PHASE I/II CLINICAL TRIAL EVALUATING DCVax-Direct, AUTOLOGOUS ACTIVATED DENDRITIC CELLS FOR INTRATUMORAL INJECTION, IN PATIENTS WITH SOLID TUMORS
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.
- Conditions
- Locally Advanced Tumor, Metastatic Solid Tissue Tumors, Liver Cancer, Colorectal Cancer, Pancreatic Cancer, Melanoma
- Being tested
- DCVax-Direct
- Medical subject headings
- Liver Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCVax-DirectBiological
Autologous, activated dendritic cells for intratumoral injection
| Study group | Role | What they receive |
|---|---|---|
| DCVax-Direct | Experimental | DCVax-Direct: autologous, activated dendritic cells for intratumoral injection Receives: Biological: DCVax-Direct |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Measured: 6 months
Secondary outcomes (1)
Number of patients with tumor response
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwest Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marnix Bosch, MBA, PhD, Study director, Northwest Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882946
- Sponsor's protocol ID
- NWBio 050012
- Status last verified
- Oct 2015
- First submitted
- 14 Jun 2013
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE I/II CLINICAL TRIAL EVALUATING DCVax-Direct, AUTOLOGOUS ACTIVATED DENDRITIC CELLS FOR INTRATUMORAL INJECTION, IN PATIENTS WITH SOLID TUMORS
- ClinicalTrials.gov ID
- NCT01882946
- Acronym / sponsor ID
- NWBio 050012
- Conditions
- Locally Advanced Tumor, Metastatic Solid Tissue Tumors, Liver Cancer, Colorectal Cancer, Pancreatic Cancer, Melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Northwest BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Dec 2016 (estimated)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCVax-Direct | Experimental | Biological: DCVax-DirectDCVax-Direct: autologous, activated dendritic cells for intratumoral injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCVax-DirectAutologous, activated dendritic cells for intratumoral injection | Biological | DCVax-Direct |
Primary outcome
Number of patients with adverse events
Time frame: 6 months
1 secondary outcome
Number of patients with tumor response
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marnix Bosch, MBA, PhD study director
Northwest Biotherapeutics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DCVax-Direct in people with Locally Advanced Tumor and Metastatic Solid Tissue Tumors, run by Northwest Biotherapeutics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2015.