MelanomaPhase 1NCT00701987
Safety, Tolerability, and Preliminary Efficacy Study of ALS-357 in Patients With Cutaneous Metastatic Melanoma
A Phase 1 study testing ALS-357 in people with Melanoma, run by Advanced Life Sciences, Inc. at 1 site in United States.
Trial summary
A phase I trial to evaluate the safety and tolerability of ALS-357 when administered for four weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic melanoma and to evaluate the effect of escalating doses of topically applied ALS-357 on histological remission of cutaneous metastatic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- ALS-357
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jun 2009
- Phase
- Phase 1
- 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
- Study Participants must be 18 years or older.
- Study Participants must have 2 sites of cutaneous metastatic melanoma that can not be removed with surgery.
- Study Participants may have been previously treated with chemotherapy or immunotherapy but not with in 4 weeks of first dose of study treatment.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Timothy Kuzel, MD contact
United States1 site, 1 recruiting
- Recruiting
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
Timothy Kuzel, MD, 312-695-1301
Timothy Kuzel, MD
About this study
Official title: Dose-escalating, Pilot Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ALS-357 Topically Administered to Patients With Cutaneous Metastatic Melanoma
A phase I trial to evaluate the safety and tolerability of ALS-357 when administered for four weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic melanoma and to evaluate the effect of escalating doses of topically applied ALS-357 on histological remission of cutaneous metastatic melanoma and induction of apoptotic biomarkers.
- Conditions
- Melanoma
- Being tested
- ALS-357
- Keywords
- Cutaneous Metastatic Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALS-357Drug
Topical application of ALS-357
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ALS-357 applied topically twice weekly for four weeks. Receives: Drug: ALS-357 |
| 2 | Experimental | ALS-357 applied topically every other day for four weeks. Receives: Drug: ALS-357 |
| 3 | Experimental | ALS-357 applied topically once daily for four weeks. Receives: Drug: ALS-357 |
| 4 | Experimental | ALS-357 applied topically twice daily for four weeks. Receives: Drug: ALS-357 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of ALS-357 when administered for four weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic melanoma.
Measured: Day 8, 15, 22, 29 and 43
Evaluate the effect of escalating doses of topically applied ALS-357 on histological remission of cutaneous metastatic melanoma and induction of apoptotic biomarkers.
Measured: Day 8, 15, 22, 29 and 43
Secondary outcomes (3)
Evaluate differences in induction of apoptosis in treated versus control lesions via TUNEL assay.
Measured: Day 15, 29 and 43
Nucleic Acid will be isolated from portions of the biopsies to be utilized for gene expression profiling by various analytical platforms and correlated with other apoptotic in situ and surface protein expression pathways.
Measured: Day 15, 29 and 43
Evaluate the plasma concentration of ALS-357 at each scheduled study visit.
Measured: Day 1, 8, 15, 22, 29 and 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2009 (estimated)
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Life Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Timothy Kuzel, MD, Principal investigator, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701987
- Sponsor's protocol ID
- ALS-357-001
- Status last verified
- Feb 2010
- First submitted
- 17 Jun 2008
- Last updated
- 3 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-escalating, Pilot Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ALS-357 Topically Administered to Patients With Cutaneous Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00701987
- Acronym / sponsor ID
- ALS-357-001
- Conditions
- Melanoma
- Keywords
- Cutaneous Metastatic Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Advanced Life Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (estimated)
- First posted
- 19 Jun 2008 (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.
A phase I trial to evaluate the safety and tolerability of ALS-357 when administered for four weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic melanoma and to evaluate the effect of escalating doses of topically applied ALS-357 on histological remission of cutaneous metastatic melanoma and induction of apoptotic biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ALS-357ALS-357 applied topically twice weekly for four weeks. |
| 2 | Experimental | Drug: ALS-357ALS-357 applied topically every other day for four weeks. |
| 3 | Experimental | Drug: ALS-357ALS-357 applied topically once daily for four weeks. |
| 4 | Experimental | Drug: ALS-357ALS-357 applied topically twice daily for four weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Study Participants must be 18 years or older.
- Study Participants must have 2 sites of cutaneous metastatic melanoma that can not be removed with surgery.
- Study Participants may have been previously treated with chemotherapy or immunotherapy but not with in 4 weeks of first dose of study treatment.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ALS-357Topical application of ALS-357 | Drug | 1, 2, 3, 4 |
Primary outcome
Evaluate the safety and tolerability of ALS-357 when administered for four weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic melanoma.
Time frame: Day 8, 15, 22, 29 and 43
Evaluate the effect of escalating doses of topically applied ALS-357 on histological remission of cutaneous metastatic melanoma and induction of apoptotic biomarkers.
Time frame: Day 8, 15, 22, 29 and 43
3 secondary outcomes
Evaluate differences in induction of apoptosis in treated versus control lesions via TUNEL assay.
Time frame: Day 15, 29 and 43
Nucleic Acid will be isolated from portions of the biopsies to be utilized for gene expression profiling by various analytical platforms and correlated with other apoptotic in situ and surface protein expression pathways.
Time frame: Day 15, 29 and 43
Evaluate the plasma concentration of ALS-357 at each scheduled study visit.
Time frame: Day 1, 8, 15, 22, 29 and 43
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2010.
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
Timothy Kuzel, MD contact
Timothy Kuzel, MD principal investigator
Robert H. Lurie Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALS-357 in people with Melanoma, run by Advanced Life Sciences, Inc. at 1 site 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 3 inclusion and 0 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 3 Feb 2010. 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 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 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.
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?
Contact Timothy Kuzel, MD (312-695-1301), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability of ALS-357 when administered for four weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic melanoma. (time frame: Day 8, 15, 22, 29 and 43). The study lists 2 primary outcomes in all. 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 3 Feb 2010.