Melanoma (Skin)Phase 1NCT00398450
Azacitidine and Interferon Alfa in Treating Patients With Metastatic Melanoma
A Phase 1 study testing recombinant interferon alfa-2b and azacitidine in people with Melanoma (Skin), run by University of California, San Diego at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Interferon alfa may interfere with the growth of tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- recombinant interferon alfa-2b and azacitidine
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Apr 2010
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic melanoma
- At least one lesion appropriate for 3 separate punch or core needle biopsies
- Must have received and failed ≥ 1 prior systemic treatment for metastatic disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT < 2 times ULN
- Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known allergies to azacitidine, interferon alfa, benzyl alcohol, or mannitol
- No uncontrolled infection
- No known HIV positivity
- No hepatitis B or hepatitis C infection
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 3 weeks since prior systemic therapy
- More than 4 weeks since prior radiotherapy to target lesions with evidence of progression
- No concurrent radiotherapy to target lesions
- No concurrent oral or IV corticosteroids
- Topical creams or ocular steroid drops are allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
About this study
Official title: A Phase I Study of 5-azacytidine (Vidaza) With Interferon α2b in Metastatic Melanoma Patients
RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Interferon alfa may interfere with the growth of tumor cells. Giving azacitidine together with interferon alfa may be an effective treatment for melanoma.
PURPOSE: This phase I trial is studying the side effects and best dose of azacitidine when given together with interferon alfa in treating patients with metastatic melanoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of azacitidine in combination with interferon alfa-2b in patients with metastatic melanoma.
- Determine if the MTD of this regimen is biologically active in these patients.
- Define and describe the toxicities associated with this regimen.
Secondary
- Determine, preliminarily, the response in patients treated with this regimen.
- Describe, preliminarily, the time to progression and overall survival of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of azacitidine.
Patients receive azacitidine subcutaneously (SC) once daily on days 1-5 (week 1) followed by interferon alfa-2b SC 3 days a week in weeks 2-4. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of azacitidine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
- Conditions
- Melanoma (Skin)
- Being tested
- recombinant interferon alfa-2b, azacitidine
- Keywords
- recurrent melanoma, stage IV melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant interferon alfa-2bBiological
azacitidineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Toxicity
Secondary outcomes (4)
Response
Survival at day 1, 12 months, 3 years, and 5 years
Relapse-free survival
Time to relapse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study startFeb 2006
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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 1
- Primary purpose
- Treatment
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Gregory Daniels, University of California, San Diego
- Investigators
- Gregory A. Daniels, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398450
- Sponsor's protocol ID
- UCSD-060199
- Other IDs
- CDR0000511743, PHARMION-UCSD-060199
- Status last verified
- Mar 2021
- First submitted
- 9 Nov 2006
- Last updated
- 3 Mar 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of 5-azacytidine (Vidaza) With Interferon α2b in Metastatic Melanoma Patients
- ClinicalTrials.gov ID
- NCT00398450
- Acronym / sponsor ID
- UCSD-060199
- Conditions
- Melanoma (Skin)
- Keywords
- recurrent melanoma, stage IV melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 10 Nov 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.
RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Interferon alfa may interfere with the growth of tumor cells. Giving azacitidine together with interferon alfa may be an effective treatment for melanoma.
PURPOSE: This phase I trial is studying the side effects and best dose of azacitidine when given together with interferon alfa in treating patients with metastatic melanoma.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of azacitidine in combination with interferon alfa-2b in patients with metastatic melanoma.
- Determine if the MTD of this regimen is biologically active in these patients.
- Define and describe the toxicities associated with this regimen.
Secondary
- Determine, preliminarily, the response in patients treated with this regimen.
- Describe, preliminarily, the time to progression and overall survival of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of azacitidine.
Patients receive azacitidine subcutaneously (SC) once daily on days 1-5 (week 1) followed by interferon alfa-2b SC 3 days a week in weeks 2-4. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of azacitidine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| recombinant interferon alfa-2b | Biological | – |
| azacitidine | Drug | – |
Primary outcome
Maximum tolerated dose
Toxicity
4 secondary outcomes
Response
Survival at day 1, 12 months, 3 years, and 5 years
Relapse-free survival
Time to relapse
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 3 Mar 2021.
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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.
Gregory A. Daniels, MD, PhD principal investigator
University of California, San Diego
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 recombinant interferon alfa-2b and azacitidine in people with Melanoma (Skin), run by University of California, San Diego 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?
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 3 Mar 2021. 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?
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?
Maximum tolerated dose. 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 Mar 2021.