NeoplasmsPhase 1/2NCT00421811
A Study of ADH-1 in Combination With Normothermic Isolated Limb Infusion of Melphalan
A Phase 1/2 study testing ADH-1 and melphalan in people with Neoplasms, run by Adherex Technologies, Inc. at 7 sites in United States.
Trial summary
N-cadherin, a protein involved in blood vessel cell binding and on the surface of many tumor cells, is increased as cancer progresses. ADH-1 blocks N-cadherin. This study will test the safety and effects of the combination ADH-1 with Normothermic Isolated Limb Infusion of Melphalan in subjects with locally advanced… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- ADH-1 and melphalan
- Type of treatment
- Injection or infusion
- How many people
- 56 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2007to Mar 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Male and female patients > or = 18 years of age with diagnosis of melanoma for which treatment with Normothermic Isolated Limb Infusion (ILI) of melphalan would be appropriate
- Measurable disease
- Disease site(s) must be distal to the planned site of tourniquet placement
- Available for immunohistochemical testing of N-cadherin expression tumor tissue
- Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and ECG
Who cannot join
- Receipt of ADH-1 prior to this clinical study (prior melphalan via ILI, is okay)
- Stage IV melanoma
- Chemotherapy, radiotherapy, or any other investigational drug within 4 weeks before study entry
- History of tumors that have shown clinically significant evidence of active bleeding within 12 weeks before study entry
- Stroke, major surgery, or other major tissue injury within 4 weeks before study entry
- Uncontrolled congestive heart failure, coronary artery disease, or life threatening arrhythmias; myocardial infarction within 12 months; significant electrocardiogram (ECG) abnormalities
- Allergic reaction to any therapeutic peptide or to melphalan
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
University of Colorado, Denver
Aurora, Colorado, 80045
Duke University Medical Center
Durham, North Carolina, 27516
University of Florida College of Medicine
Gainesville, Florida, 32610
MD Anderson Cancer Center
Houston, Texas, 77030
Intermountain Medical Center
Murray, Utah, 84157
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: An Open-Label, Multicenter, Phase 1/2 Dose Escalation Study to Evaluate Safety, Tolerability and Anti-tumor Activity of Systemic ADH-1 in Combination With Normothermic Isolated Limb Infusion of Melphalan in Subjects With Locally Advanced In-Transit Malignant Melanoma (Adherex Protocol Number AHX-01-007).
N-cadherin, a protein involved in blood vessel cell binding and on the surface of many tumor cells, is increased as cancer progresses. ADH-1 blocks N-cadherin. This study will test the safety and effects of the combination ADH-1 with Normothermic Isolated Limb Infusion of Melphalan in subjects with locally advanced malignant melanoma.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADH-1Drug
4 gm IV Days 1 and 8
melphalanDrug
By Isolated Limb Infusion (ILI), Lower Extremity: 7.5 mg/L (Limb Volume), Day 1 or Upper Extremity: 10 mg/L (Limb Volume), Day 1
What is being measured
The primary outcome is the main question the study is designed to answer.
To tabulate the Best Overall Response according to unconfirmed RECIST, modified for cutaneous lesions
Measured: By Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2007 (estimated)
- Study startApr 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adherex Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Doug Tyler, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421811
- Sponsor's protocol ID
- AHX-01-007
- Status last verified
- Dec 2010
- First submitted
- 10 Jan 2007
- Last updated
- 28 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Phase 1/2 Dose Escalation Study to Evaluate Safety, Tolerability and Anti-tumor Activity of Systemic ADH-1 in Combination With Normothermic Isolated Limb Infusion of Melphalan in Subjects With Locally Advanced In-Transit Malignant Melanoma (Adherex Protocol Number AHX-01-007).
- ClinicalTrials.gov ID
- NCT00421811
- Acronym / sponsor ID
- AHX-01-007
- Conditions
- Neoplasms
- Keywords
- cancer, tumors, melanoma, anticarcinogenic agents, antineoplastic agents, cadherins, solid tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Adherex Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 12 Jan 2007 (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.
N-cadherin, a protein involved in blood vessel cell binding and on the surface of many tumor cells, is increased as cancer progresses. ADH-1 blocks N-cadherin. This study will test the safety and effects of the combination ADH-1 with Normothermic Isolated Limb Infusion of Melphalan in subjects with locally advanced malignant melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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
Key inclusion criteria (6 listed)
- Signed written informed consent
- Male and female patients > or = 18 years of age with diagnosis of melanoma for which treatment with Normothermic Isolated Limb Infusion (ILI) of melphalan would be appropriate
- Measurable disease
- Disease site(s) must be distal to the planned site of tourniquet placement
- Available for immunohistochemical testing of N-cadherin expression tumor tissue
Key exclusion criteria (7 listed)
- Receipt of ADH-1 prior to this clinical study (prior melphalan via ILI, is okay)
- Stage IV melanoma
- Chemotherapy, radiotherapy, or any other investigational drug within 4 weeks before study entry
- History of tumors that have shown clinically significant evidence of active bleeding within 12 weeks before study entry
- Stroke, major surgery, or other major tissue injury within 4 weeks before study entry
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 |
|---|---|---|
| ADH-14 gm IV Days 1 and 8 | Drug | – |
| melphalanBy Isolated Limb Infusion (ILI), Lower Extremity: 7.5 mg/L (Limb Volume), Day 1 or Upper Extremity: 10 mg/L (Limb Volume), Day 1 | Drug | – |
Primary outcome
To tabulate the Best Overall Response according to unconfirmed RECIST, modified for cutaneous lesions
Time frame: By Week 12
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 28 Dec 2010.
- (Adherex Technologies Inc. Corporate Homepage)Link provided by the sponsor.
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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.
Doug Tyler, MD principal investigator
Duke University
7 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 ADH-1 and melphalan in people with Neoplasms, run by Adherex Technologies, Inc. at 7 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 28 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
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.
What does the primary outcome measure?
To tabulate the Best Overall Response according to unconfirmed RECIST, modified for cutaneous lesions (time frame: By Week 12). 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 28 Dec 2010.