Metastatic CancerPhase 2NCT00348842
Newcastle Disease Virus (NDV) for Cancer Patients Resistant to Conventional Anti-cancer Modalities
A Phase 2 study testing Newcastle Virus in people with Metastatic Cancer and Newcastle Disease Virus (NDV), run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
NDV is a virus tht is harmful in chicken, but harmless in man. There are 2 major sub-strains of NDV, one oncolytic and one non-oncolytic. Oncolytic NDV (MTH-68H) preferentially homes and replicates in cancer cells and therefore, administration of NDV intravenously or preferentially intra-tumor, either by direct… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Cancer, Newcastle Disease Virus (NDV)
- What is being tested?
- Newcastle Virus
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Mar 2006to Jun 2006
- Phase
- Phase 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with the following disease category will be eligible:
- Patients with metastatic lung cancer, metastatic GI cancer, metastatic urogenital cancer, skin and soft tissue cancer.
- Failure to anti-cancer modalties and evidence of progressive disease despite optimal application of all relevant available anti-cancer modalities.
- Consenting patients.
- The patient should sign a consent form stating that he/she will make sure to avoid any contact with chicken or any other species of birds.
Who cannot join
- Not fulfilling any of the above criteria.
- Moribund patients or patients with life-expectancy <3 months.
- Karnofsky performance status <60%.
- Pregnant or lactating women.
- Active local or systemic infections requiring treatment.
- Co-morbidity or life-threatening clinical condtion other than the basic cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II: Safety and Primary Efficacy of Clinical Application of Newcastle Disease Virus for the Treatment of Patients Resistant to All Conventional Modalities
NDV is a virus tht is harmful in chicken, but harmless in man. There are 2 major sub-strains of NDV, one oncolytic and one non-oncolytic. Oncolytic NDV (MTH-68H) preferentially homes and replicates in cancer cells and therefore, administration of NDV intravenously or preferentially intra-tumor, either by direct injection or by injection into an afferent artery results in direct lysis of tumor cells. NDV activates apoptotic mechanism in cancer cells and thus, results in natural cell death.
Both oncolytic and non-oncolytic NDV were used clinically in hundreds of patients with different types of cancer worldwide. NDV were proved harmless in man. Clinical studies were done for more than a decade and the efficacy of NDV was documented on pre-clinical animals models as well as in man.
For a large number of patients with metastatic cancer and chemotherapy resistant hematological malignances, no cure can be provided by conventional anti-cancer modalities, new treatment options are urgently indicated. The goal of the study is to use NDV, in order to provide such treatment for patients in need.
- Conditions
- Metastatic Cancer, Newcastle Disease Virus (NDV)
- Being tested
- Newcastle Virus
- Keywords
- Immunotherapy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Newcastle VirusProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and primary efficacy of NDV treatment in cancer patients who failed conventional modalities.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study startMar 2006
- Study completionJun 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Shimon Slavin, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348842
- Sponsor's protocol ID
- 397231205-HMO-CTIL
- Status last verified
- Feb 2006
- First submitted
- 4 Jul 2006
- Last updated
- 8 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II: Safety and Primary Efficacy of Clinical Application of Newcastle Disease Virus for the Treatment of Patients Resistant to All Conventional Modalities
- ClinicalTrials.gov ID
- NCT00348842
- Acronym / sponsor ID
- 397231205-HMO-CTIL
- Conditions
- Metastatic Cancer, Newcastle Disease Virus (NDV)
- Keywords
- Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Jun 2006 (estimated)
- First posted
- 6 Jul 2006 (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.
NDV is a virus tht is harmful in chicken, but harmless in man. There are 2 major sub-strains of NDV, one oncolytic and one non-oncolytic. Oncolytic NDV (MTH-68H) preferentially homes and replicates in cancer cells and therefore, administration of NDV intravenously or preferentially intra-tumor, either by direct injection or by injection into an afferent artery results in direct lysis of tumor cells. NDV activates apoptotic mechanism in cancer cells and thus, results in natural cell death.
Both oncolytic and non-oncolytic NDV were used clinically in hundreds of patients with different types of cancer worldwide. NDV were proved harmless in man. Clinical studies were done for more than a decade and the efficacy of NDV was documented on pre-clinical animals models as well as in man.
For a large number of patients with metastatic cancer and chemotherapy resistant hematological malignances, no cure can be provided by conventional anti-cancer modalities, new treatment options are urgently indicated. The goal of the study is to use NDV, in order to provide such treatment for patients in need.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with the following disease category will be eligible:
- Patients with metastatic lung cancer, metastatic GI cancer, metastatic urogenital cancer, skin and soft tissue cancer.
- Failure to anti-cancer modalties and evidence of progressive disease despite optimal application of all relevant available anti-cancer modalities.
- Consenting patients.
- The patient should sign a consent form stating that he/she will make sure to avoid any contact with chicken or any other species of birds.
Key exclusion criteria (6 listed)
- Not fulfilling any of the above criteria.
- Moribund patients or patients with life-expectancy <3 months.
- Karnofsky performance status <60%.
- Pregnant or lactating women.
- Active local or systemic infections requiring treatment.
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 |
|---|---|---|
| Newcastle Virus | Procedure or surgery | – |
Primary outcome
Safety and primary efficacy of NDV treatment in cancer patients who failed conventional modalities.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2011.
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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.
Shimon Slavin, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Newcastle Virus in people with Metastatic Cancer and Newcastle Disease Virus (NDV), run by Hadassah Medical Organization at 1 site in Israel.
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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 8 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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 phase mean?
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Safety and primary efficacy of NDV treatment in cancer patients who failed conventional modalities.. 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 8 Apr 2011.