Stage IA Skin MelanomaNCT01460875
Recombinant Interferon Alfa-2b in Treating Patients With Melanoma
A study testing recombinant interferon alfa-2b and laboratory biomarker analysis in people with Stage IA Skin Melanoma and Stage IB Skin Melanoma, run by William Carson at 1 site in United States.
Trial summary
This pilot clinical trial studies recombinant interferon alfa-2b in treating patients with melanoma. Recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Stage IA Skin Melanoma, Stage IB Skin Melanoma, Stage IIA Skin Melanoma
- What is being tested?
- recombinant interferon alfa-2b and laboratory biomarker analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2008to 5 Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must be considered a candidate for adjuvant IFN-alpha-2b therapy after having undergone successful surgery for high-risk melanoma (Breslow thickness > 4 mm or lymph node disease) or complete resection of metastatic disease; definitive surgery should have been accomplished no greater than 90 days prior to start of treatment with intravenous IFN-alpha-2b
- Patients must have completed 20 treatments of intravenous IFN-alpha-2b according to standard practice within 2 months of beginning treatment on this study
- Patients must have not have any evidence of persistent or recurrent disease as determined by the appropriate radiologic imaging techniques
- Patients may have received prior IFN-alpha therapy for metastatic disease, but more than 6 months must have passed between the last dose of IFN-alpha therapy for metastatic disease and the first dose of intravenous IFN-alpha-2b; patients who have had prior interleukin (IL)-2 are eligible for this study
- Patients may have received radiation therapy after intravenous IFN-alpha-2b; they may begin subcutaneous dosing of IFN-alpha-2b on this study after the radiation therapy has been completed; the patient may initiate dose reductions after the last radiation treatment as long as the appropriate amount of time has passed
- Life expectancy of greater than 6 months
Show all 18Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 70%)
- Leukocytes >= 3,000/ul
- Absolute neutrophil count >= 1,500/ul
- Platelets >= 100,000/ul
- Total bilirubin =< 2.0 (Gilbert's disease permitted)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) < 3 x institutional upper limit of normal
- Creatinine =< 1.5 and stable OR
- Creatinine clearance >= 60 mL.min/1.73 m^2 for patients with creatinine levels above normal
- Pulse oximetry >= 90% on room air at rest
- Serum pregnancy test negative
- The effects of interferon alpha-2b on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, and because interferons are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- All patients must be informed of the investigational nature of this study and must provide written informed consent in accordance with institutional and federal guidelines; a copy of the informed consent document signed by the patient must be given to the patient
Who cannot join
- Patients may not be receiving any investigational agents
- History of allergic reactions attributed to compounds that are similar to interferon alpha-2b
- Patients known to be positive for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbsAg) or hepatitis C antibody
- Patients with organ allografts or immunodeficiency syndromes
- Patients with prior malignancies may participate provided they have been free of disease for at least 2 years except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; a history of depression in and of itself is not an exclusion to going participating provided the patient and physician believe the depression is controlled and the patient will discontinue the IFN-alpha should symptoms recur
- Pregnant women are excluded from this study because interferon alpha-2b is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with IFN-alpha, breastfeeding should be discontinued if the mother is treated with IFN-alpha
- Prisoners will be excluded due to the need for multiple timed visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Pilot Study of IFN-alpha-2b Dose Reduction With Dose Optimization
This pilot clinical trial studies recombinant interferon alfa-2b in treating patients with melanoma. Recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma
Read the detailed description
PRIMARY OBJECTIVES:
- To determine whether selection of the optimal IFN-alpha-2b (recombinant interferon alfa-2b) dose can be made using signal transduction data.
SECONDARY OBJECTIVES:
- To determine the tolerability of adjuvant IFN-alpha-2b administered at an optimized dose in terms of the toxicities that are observed and the ability of patients to receive a full year of therapy.
II. The transcription of a panel of IFN-alpha-induced genes previously identified by microarray analysis will be determined by Real-Time reverse transcriptase-polymerase chain reaction (RT PCR) in order that the correlation between signal transducer and activator of transcription 1 (STAT1) phosphorylation and IFN-alpha gene regulation can be evaluated.
III. Microarray analysis of patient peripheral blood mononuclear cells (PBMCs) will be used to evaluate the effect of dose-reduction on IFN-alpha gene expression.
IV. In order to define the clinical role of tumor sensitivity to IFN-alpha, patient tumor biopsies taken prior to the administration of IFN-alpha will be systematically evaluated for cellular levels of janus kinase (Jak)-STAT signaling intermediates.
OUTLINE:
Patients receive recombinant interferon alfa-2b subcutaneously (SC) thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3-6 months for 2 years.
- Conditions
- Stage IA Skin Melanoma, Stage IB Skin Melanoma, Stage IIA Skin Melanoma, Stage IIB Skin Melanoma, Stage IIC Skin Melanoma, Stage IIIA Skin Melanoma
- Being tested
- recombinant interferon alfa-2b, laboratory biomarker analysis
- Keywords
- high risk melanoma, lymph node disease
- 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
Also called Alfatronol, Glucoferon, Heberon Alfa, IFN alpha-2B
Given SC
laboratory biomarker analysisOther
Also called Correlative studies
Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (interferon therapy) | Experimental | Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity. Receives: Biological: recombinant interferon alfa-2b; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Activated STAT1(Phospho-STAT1)
Mean and 95% confidence interval will be summarized for phospho-STAT1 at a lower dose and the standard dose. The phospho-STAT1 will also be compared between the dose levels.
Measured: up to 4 weeks
Secondary outcomes (7)
Number of Patients With Adverse Events
Determine the tolerability of adjuvant IFN-α-2b administered at an optimized dose in terms of the toxicities that are observed and the ability of patients to receive a full year of therapy.
Measured: up to 1 year
Percentage of Patients With Correlation Between STAT1 Phosphorylation and Interferon Alfa Gene Regulation
Levels of p-STAT1 in PBMCs were analyzed just prior to IFN-a-2b administration to determine levels that remained stable or increased over the course of dose reduction.
Measured: Prior to treatment and 1 and 4 hours post therapy on day 1 every other week during the first 12 weeks, and then every 3 months
Effect of Dose-reduction on Expression of Interferon Alfa Stimulated Genes
Evaluated using microarray analysis of patient PBMCs. Compared using the Wilcoxon signed rank test for the dose 10MU/m2
Measured: 1 hour post therapy
Effect of Dose-reduction on Interferon Alfa Gene Expression
Evaluated using microarray analysis of patient PBMCs. Compared using the Wilcoxon signed rank test for the dose 4MU/m2
Measured: 1 hour post therapy
Effect of Dose-reduction on Interferon Alfa Gene Expression Through Marker CD69
Evaluated using microarray analysis of patient PBMCs. Compared between doses using the Wilcoxon signed rank test.
Measured: 4 hours post therapy
Effect of Dose-reduction on Interferon Alfa Gene Expression at Dose Level 4MU
Evaluated using microarray analysis of patient PBMCs. Compared between doses using the Wilcoxon signed rank test.
Measured: 4 hours post therapy
Clinical Role of Tumor Sensitivity to Recombinant Interferon Alfa-2b Using Cellular Levels of Jak-STAT Signaling Intermediates
Define the clinical role of tumor sensitivity to IFN-α, patient tumor biopsies taken prior to the administration of IFN-α will be systematically evaluated for cellular levels of Jak-STAT signaling intermediates.
Measured: Baseline and every other week prior to recombinant interferon alfa-2b administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study start22 Apr 2008
- Primary completion5 Jan 2014
- Study completion5 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stage IA Skin 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Carson
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Responsible party
- Sponsor-investigator, William Carson, Ohio State University Comprehensive Cancer Center
- Investigators
- William Carson, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460875
- Sponsor's protocol ID
- OSU-07033
- Other IDs
- NCI-2011-03121
- Status last verified
- Oct 2018
- First submitted
- 25 Oct 2011
- Last updated
- 2 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of IFN-alpha-2b Dose Reduction With Dose Optimization
- ClinicalTrials.gov ID
- NCT01460875
- Acronym / sponsor ID
- OSU-07033
- Conditions
- Stage IA Skin Melanoma, Stage IB Skin Melanoma, Stage IIA Skin Melanoma, Stage IIB Skin Melanoma, Stage IIC Skin Melanoma, Stage IIIA Skin Melanoma
- Keywords
- high risk melanoma, lymph node disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- William CarsonUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- 22 Apr 2008 (actual)
- Primary completion
- 5 Jan 2014 (actual)
- Study completion
- 5 Jan 2014 (actual)
- First posted
- 27 Oct 2011 (estimated)
- Results
- Posted 2 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical trial studies recombinant interferon alfa-2b in treating patients with melanoma. Recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma
Detailed description
PRIMARY OBJECTIVES:
- To determine whether selection of the optimal IFN-alpha-2b (recombinant interferon alfa-2b) dose can be made using signal transduction data.
SECONDARY OBJECTIVES:
- To determine the tolerability of adjuvant IFN-alpha-2b administered at an optimized dose in terms of the toxicities that are observed and the ability of patients to receive a full year of therapy.
II. The transcription of a panel of IFN-alpha-induced genes previously identified by microarray analysis will be determined by Real-Time reverse transcriptase-polymerase chain reaction (RT PCR) in order that the correlation between signal transducer and activator of transcription 1 (STAT1) phosphorylation and IFN-alpha gene regulation can be evaluated.
III. Microarray analysis of patient peripheral blood mononuclear cells (PBMCs) will be used to evaluate the effect of dose-reduction on IFN-alpha gene expression.
IV. In order to define the clinical role of tumor sensitivity to IFN-alpha, patient tumor biopsies taken prior to the administration of IFN-alpha will be systematically evaluated for cellular levels of janus kinase (Jak)-STAT signaling intermediates.
OUTLINE:
Patients receive recombinant interferon alfa-2b subcutaneously (SC) thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3-6 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (interferon therapy) | Experimental | Biological: recombinant interferon alfa-2b, Other: laboratory biomarker analysisPatients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Patients must be considered a candidate for adjuvant IFN-alpha-2b therapy after having undergone successful surgery for high-risk melanoma (Breslow thickness > 4 mm or lymph node disease) or complete resection of metastatic disease; definitive surgery should have been accomplished no greater than 90 days prior to start of treatment with intravenous IFN-alpha-2b
- Patients must have completed 20 treatments of intravenous IFN-alpha-2b according to standard practice within 2 months of beginning treatment on this study
- Patients must have not have any evidence of persistent or recurrent disease as determined by the appropriate radiologic imaging techniques
- Patients may have received prior IFN-alpha therapy for metastatic disease, but more than 6 months must have passed between the last dose of IFN-alpha therapy for metastatic disease and the first dose of intravenous IFN-alpha-2b; patients who have had prior interleukin (IL)-2 are eligible for this study
- Patients may have received radiation therapy after intravenous IFN-alpha-2b; they may begin subcutaneous dosing of IFN-alpha-2b on this study after the radiation therapy has been completed; the patient may initiate dose reductions after the last radiation treatment as long as the appropriate amount of time has passed
Key exclusion criteria (8 listed)
- Patients may not be receiving any investigational agents
- History of allergic reactions attributed to compounds that are similar to interferon alpha-2b
- Patients known to be positive for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbsAg) or hepatitis C antibody
- Patients with organ allografts or immunodeficiency syndromes
- Patients with prior malignancies may participate provided they have been free of disease for at least 2 years except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix
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-2bAlso: Alfatronol, Glucoferon, Heberon Alfa, IFN alpha-2BGiven SC | Biological | Treatment (interferon therapy) |
| laboratory biomarker analysisAlso: Correlative studiesBlood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy. | Other | Treatment (interferon therapy) |
Primary outcome
Level of Activated STAT1(Phospho-STAT1)
Time frame: up to 4 weeks
Mean and 95% confidence interval will be summarized for phospho-STAT1 at a lower dose and the standard dose. The phospho-STAT1 will also be compared between the dose levels.
7 secondary outcomes
Number of Patients With Adverse Events
Time frame: up to 1 year
Percentage of Patients With Correlation Between STAT1 Phosphorylation and Interferon Alfa Gene Regulation
Time frame: Prior to treatment and 1 and 4 hours post therapy on day 1 every other week during the first 12 weeks, and then every 3 months
Effect of Dose-reduction on Expression of Interferon Alfa Stimulated Genes
Time frame: 1 hour post therapy
Effect of Dose-reduction on Interferon Alfa Gene Expression
Time frame: 1 hour post therapy
Effect of Dose-reduction on Interferon Alfa Gene Expression Through Marker CD69
Time frame: 4 hours post therapy
Effect of Dose-reduction on Interferon Alfa Gene Expression at Dose Level 4MU
Time frame: 4 hours post therapy
Clinical Role of Tumor Sensitivity to Recombinant Interferon Alfa-2b Using Cellular Levels of Jak-STAT Signaling Intermediates
Time frame: Baseline and every other week prior to recombinant interferon alfa-2b administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- JameslineLink 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.
William Carson, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing recombinant interferon alfa-2b and laboratory biomarker analysis in people with Stage IA Skin Melanoma and Stage IB Skin Melanoma, run by William Carson 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 18 inclusion and 8 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 2 Nov 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Level of Activated STAT1(Phospho-STAT1) (time frame: up to 4 weeks). 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 2 Nov 2018.