MelanomaPhase 2NCT00044356
Phase II Trial of Allovectin-7® for Metastatic Melanoma
A Phase 2 study testing Allovectin-7® in people with Melanoma and Metastatic Melanoma, run by Vical at 16 sites in United States.
Trial summary
The purpose of this clinical trial is to determine if Allovectin-7®, an experimental gene-based immunotherapy, can shrink melanoma tumors. The trial will also examine if this treatment can improve the time to disease progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Metastatic Melanoma, Malignant Melanoma
- What is being tested?
- Allovectin-7®
- How many people
- 133 participants
- Where
- 16 sitesUnited States
- Study dates
- Feb 2001to Sep 2004
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
In order to be in this trial, you must meet the enrollment criteria. Below is a list of some of the enrollment criteria.
- You have been diagnosed with Stage III or Stage IV melanoma
- Your cancer has returned after a prior treatment (e.g. radiation or chemotherapy) or you refused therapy with standard treatment
- You are able to carry out your normal daily activities
- Your melanoma has not spread to your brain
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Comprehensive Blood and Cancer Center
Bakersfield, California, 48202
Hematology Oncology Associates of Baltimore
Baltimore, Maryland, 21236
University of Colorado Cancer Center
Denver, Colorado, 80010
Duke University Medical Center
Durham, North Carolina, 27710
MD Anderson Cancer Center
Houston, Texas, 77030
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Arkansas Cancer Research Center
Little Rock, Arkansas, 72205
Louisiana State University Medical Center
New Orleans, Louisiana, 70112
Beth Israel Medical Center
New York, New York, 10003
Oncology Specialists, S.C.
Park Ridge, Illinois, 60068
North Memorial Health Care
Robbinsdale, Minnesota, 55422
Mayo Clinic
Rochester, Minnesota, 55905
University of California, San Francisco
San Francisco, California, 94115
Cancer Care Alliance
Seattle, Washington, 98109
The Melanoma Center of Saint Louis
St Louis, Missouri, 63131
Arizona Cancer Center
Tucson, Arizona, 85724
About this study
Official title: A Phase II Study of High-Dose Allovectin-7® in Patients With Advanced Metastatic Melanoma
The purpose of this clinical trial is to determine if Allovectin-7®, an experimental gene-based immunotherapy, can shrink melanoma tumors. The trial will also examine if this treatment can improve the time to disease progression.
Read the detailed description
Treatment - If you take part in this trial you will be treated for about 10 weeks. You will receive an injection of Allovectin-7® by needle, directly into one or more selected tumors once a week for the first six weeks. The injections may be given in a doctor's office. During a four-week observation period, your disease will be measured to see if the treatment is working. This will be done by general physical exams and scans (such as X-ray scans). Patients who show no sign of disease progression may be offered an option to repeat this treatment course.
- Conditions
- Melanoma, Metastatic Melanoma, Malignant Melanoma, Skin Cancer
- Being tested
- Allovectin-7®
- Keywords
- Melanoma, Metastatic Melanoma, Malignant Melanoma, Skin Cancer, Tumor, Experimental Treatment, Clinical Trial, Gene Therapy, Gene Delivery, Gene Transfer, Immunotherapy, Cancer, Neoplasm, Lesion, Metastasis, Cancerous mole, Melanoma vaccine, Cancer research, Cancer cells, Allovectin-7®
- Medical subject headings
- Melanoma, Skin Neoplasms, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allovectin-7®Genetic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2002 (estimated)
- Study startFeb 2001
- Primary completionAug 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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 2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044356
- Sponsor's protocol ID
- VCL-1005-208
- Status last verified
- Jul 2011
- First submitted
- 26 Aug 2002
- Last updated
- 7 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of High-Dose Allovectin-7® in Patients With Advanced Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00044356
- Acronym / sponsor ID
- VCL-1005-208
- Conditions
- Melanoma, Metastatic Melanoma, Malignant Melanoma, Skin Cancer
- Keywords
- Melanoma, Metastatic Melanoma, Malignant Melanoma, Skin Cancer, Tumor, Experimental Treatment, Clinical Trial, Gene Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- VicalIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- Primary completion
- Aug 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 28 Aug 2002 (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 purpose of this clinical trial is to determine if Allovectin-7®, an experimental gene-based immunotherapy, can shrink melanoma tumors. The trial will also examine if this treatment can improve the time to disease progression.
Detailed description
Treatment - If you take part in this trial you will be treated for about 10 weeks. You will receive an injection of Allovectin-7® by needle, directly into one or more selected tumors once a week for the first six weeks. The injections may be given in a doctor's office. During a four-week observation period, your disease will be measured to see if the treatment is working. This will be done by general physical exams and scans (such as X-ray scans). Patients who show no sign of disease progression may be offered an option to repeat this treatment course.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Allovectin-7® | Genetic | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allovectin-7® in people with Melanoma and Metastatic Melanoma, run by Vical at 16 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?
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: finished, as of the sponsor's last update on 7 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 Jul 2011.