MelanomaEarly Phase 1NCT00871533
Pilot Study of IFN α2b for Melanoma Patients
A Early Phase 1 study testing IFNα2b and PEG- IFNα2b in people with Melanoma, run by University of Pittsburgh at 1 site in United States.
Trial summary
The presence of malignant cells in lymph nodes is a critical parameter in the staging of melanoma cancer patients. Assessment of lymph nodes is currently done by histopathology alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- IFNα2b and PEG- IFNα2b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Aug 2017
- Phase
- Early 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
- Primary melanoma with the following Breslow thickness and stage
- less than or equal to 2 mm
- Patients with recent (within 12 wks) biopsy of primary melanoma that has not been widely resected will be eligible for study according to the above-specified criteria for tumor thickness and stage.
- Age 18 years or older.
- Patients must have documented hemoglobin level of 10g/dL or higher and normal organ function tests including BUN, Creatinine, and liver enzyme panel to include AST, ALT, and Bilirubin. This can be drawn on the day of consent, or be documented from a previous visit within the past 30 days
- Negative serum pregnancy test
- Subjects must have provided written, informed consent prior to any study procedures: collection of blood and LN tissue specimens for this protocol.
Who cannot join
- Serious illnesses, such as: cardiovascular disease (uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, severe cardiac arrhythmia), bleeding disorders, autoimmune diseases, severe obstructive or restrictive pulmonary diseases, active systemic infections, inflammatory bowel disorders, severe renal disease.
- Any significant psychiatric disease, medical intervention, or other condition, which in the opinion of the Principal Investigator or Co-Investigators, could prevent adequate informed consent or compromise participation in the clinical trial.
- Active infection or antibiotics within one-week prior to study.
- Systemic steroid or other immunosuppressive therapy administered for more than 10 days within 4 weeks of enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Pilot Analysis of the Effects of IFN α2b Upon the Molecular Profile of Regional Lymph Nodes in Melanoma Patients With and Without Tumor-Involved Sentinel Lymph Nodes
The presence of malignant cells in lymph nodes is a critical parameter in the staging of melanoma cancer patients. Assessment of lymph nodes is currently done by histopathology alone. The long-term survival of melanoma cancer patients who have Stage IB disease (no known lymph node involvement with a tumor greater than 2 cm) is lower than patients who are Stage IA (no known lymph node involvement with a tumor less than 2 cm). Likewise, the survival rates of patients who are judged to be Stage II based on histologically positive level-one lymph nodes is often no better than that of higher stage patients who have level-two lymph node involvement. These observations suggest that micrometastases are often present in lymph nodes that are not detectable by histological assessment.
The collection of Sentinel Lymph Nodes (SLN) and non SLN material outlined in this proposal will permit both targeted and exploratory studies, without compromising the patient's diagnosis, on specimens that represent central engines of the immune response and whose function in the context of tumor progression is largely unknown.
With the advent of an array of new methodologies that utilize minimum material for both molecular and cellular assessments, acquiring up to 20% and in general the investigators anticipate the use of 5% on average of SLN and/or non SLN tissue for research purposes, may prove to be critical to understanding the impact of nodal tumor involvement on patient outcome and survival.
- Conditions
- Melanoma
- Being tested
- IFNα2b, PEG- IFNα2b
- Keywords
- Biochemical Marker, Biochemical Markers, Biologic Marker, Biologic Markers, Biomarkers, Clinical Marker, Clinical Markers, Immune Marker, Immune Markers, Immunologic Marker, Immunologic Markers, Laboratory Marker, Laboratory Markers, Marker, Biochemical, Marker, Biological, Marker, Clinical, Marker, Immunologic, Marker, Laboratory, Marker, Serum, Marker, Surrogate
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IFNα2bDrug
IV injection at 20 million IU/m2. IFNα2b IV injection will be performed every day between day -14 and day -9 (5 infusions) and also every day between day -7 and day -2 (5 infusions) for a total of 10 infusions.
IFNα2bDrug
SC injections peri-lesionally (PL) in the vicinity of the primary, at 10 million IU/m2. IFNα2b Injection will be performed every other day between day -14 and day -9 (3 injections) and also every other day between day -7 and day -2 (3 injections) for a total of 6 injections.
PEG- IFNα2bDrug
SC injection at 6mcg/kg will be performed systemically (at site that is not regional): first injection at day -14, second injection at day -7, for a total of 2 injections.
PEG- IFNα2bDrug
SC injections peri-lesionally (PL) in the vicinity of the primary at 3ug/kg: first injection at day -14, second injection at day -7, for a total of 2 injections.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | REGIONAL PEG IFN MAINTENANCE: Regional PEG IFN-a2b given subcutaneously at "MAINTENANCE" dose level. (This arm has completed enrollment; non-evaluable subjects as defined in section 9.5 may be replaced at any point during study. Receives: Drug: IFNα2b |
| 2 | Experimental | No intervention / no injection control. Receives: Drug: IFNα2b |
| 3 | Experimental | PEG IFN INDUCTION: System PEG IFN-a2b given subcutaneously at "INDUCTION" dose level Receives: Drug: PEG- IFNα2b |
| 4 | Experimental | REGIONAL HDI MAINTENANCE: Regional HDI given subcutaneously at "MAINTENANCE" dose level per standard HDI regimen Receives: Drug: PEG- IFNα2b |
| 5 | No intervention | HDI Induction: Systemic HDI given intravenously at "INDUCTION" dose level per the standard HDI regimen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To utilize gene-profiling analysis of regional lymph node tissue to molecularly characterize the effect of IFN α2b and PEG IFNα2b on the SLN. Endpoint: mRNA expression by gene array.
Measured: 5
Secondary outcomes (2)
Quantitate putative biomarkers differentially expressed in the SLN for each active treatment group and among all active treatment groups combined. Endpoint: mRNA expression by Taqman.
Measured: 5
Molecularly characterize the effect of perilesional IFN α2b and PEG IFNα2b administered as close as possible to the primary tumor site on SLNs that are positive vs. negative for tumor micrometastases. Endpoint: mRNA expression by gene array.
Measured: 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2017
- Study completionAug 2017
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.
- More trials run by University of PittsburghThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Responsible party
- Principal investigator, Ahmad Tarhini, University of Pittsburgh
- Investigators
- Ahmad Tarhini, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871533
- Sponsor's protocol ID
- 08-067
- Status last verified
- Aug 2017
- First submitted
- 26 Mar 2009
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Analysis of the Effects of IFN α2b Upon the Molecular Profile of Regional Lymph Nodes in Melanoma Patients With and Without Tumor-Involved Sentinel Lymph Nodes
- ClinicalTrials.gov ID
- NCT00871533
- Acronym / sponsor ID
- 08-067
- Conditions
- Melanoma
- Keywords
- Biochemical Marker, Biochemical Markers, Biologic Marker, Biologic Markers, Biomarkers, Clinical Marker, Clinical Markers, Immune Marker
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Sep 2009
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 30 Mar 2009 (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 presence of malignant cells in lymph nodes is a critical parameter in the staging of melanoma cancer patients. Assessment of lymph nodes is currently done by histopathology alone. The long-term survival of melanoma cancer patients who have Stage IB disease (no known lymph node involvement with a tumor greater than 2 cm) is lower than patients who are Stage IA (no known lymph node involvement with a tumor less than 2 cm). Likewise, the survival rates of patients who are judged to be Stage II based on histologically positive level-one lymph nodes is often no better than that of higher stage patients who have level-two lymph node involvement. These observations suggest that micrometastases are often present in lymph nodes that are not detectable by histological assessment.
The collection of Sentinel Lymph Nodes (SLN) and non SLN material outlined in this proposal will permit both targeted and exploratory studies, without compromising the patient's diagnosis, on specimens that represent central engines of the immune response and whose function in the context of tumor progression is largely unknown.
With the advent of an array of new methodologies that utilize minimum material for both molecular and cellular assessments, acquiring up to 20% and in general the investigators anticipate the use of 5% on average of SLN and/or non SLN tissue for research purposes, may prove to be critical to understanding the impact of nodal tumor involvement on patient outcome and survival.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: IFNα2bREGIONAL PEG IFN MAINTENANCE: Regional PEG IFN-a2b given subcutaneously at "MAINTENANCE" dose level. (This arm has completed enrollment; non-evaluable subjects as defined in section 9.5 may be replaced at any point during study. |
| 2 | Experimental | Drug: IFNα2bNo intervention / no injection control. |
| 3 | Experimental | Drug: PEG- IFNα2bPEG IFN INDUCTION: System PEG IFN-a2b given subcutaneously at "INDUCTION" dose level |
| 4 | Experimental | Drug: PEG- IFNα2bREGIONAL HDI MAINTENANCE: Regional HDI given subcutaneously at "MAINTENANCE" dose level per standard HDI regimen |
| 5 | No intervention | –HDI Induction: Systemic HDI given intravenously at "INDUCTION" dose level per the standard HDI regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Primary melanoma with the following Breslow thickness and stage
- Age 18 years or older.
- Patients must have documented hemoglobin level of 10g/dL or higher and normal organ function tests including BUN, Creatinine, and liver enzyme panel to include AST, ALT, and Bilirubin. This can be drawn on the day of consent, or be documented from a previous visit within the past 30 days
- Negative serum pregnancy test
- Subjects must have provided written, informed consent prior to any study procedures: collection of blood and LN tissue specimens for this protocol.
Key exclusion criteria (4 listed)
- Serious illnesses, such as: cardiovascular disease (uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, severe cardiac arrhythmia), bleeding disorders, autoimmune diseases, severe obstructive or restrictive pulmonary diseases, active systemic infections, inflammatory bowel disorders, severe renal disease.
- Any significant psychiatric disease, medical intervention, or other condition, which in the opinion of the Principal Investigator or Co-Investigators, could prevent adequate informed consent or compromise participation in the clinical trial.
- Active infection or antibiotics within one-week prior to study.
- Systemic steroid or other immunosuppressive therapy administered for more than 10 days within 4 weeks of enrollment.
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 |
|---|---|---|
| IFNα2bIV injection at 20 million IU/m2. IFNα2b IV injection will be performed every day between day -14 and day -9 (5 infusions) and also every day between day -7 and day -2 (5 infusions) for a total of 10 infusions. | Drug | 1 |
| IFNα2bSC injections peri-lesionally (PL) in the vicinity of the primary, at 10 million IU/m2. IFNα2b Injection will be performed every other day between day -14 and day -9 (3 injections) and also every other day between day -7 and day -2 (3 injections) for a total of 6 injections. | Drug | 2 |
| PEG- IFNα2bSC injection at 6mcg/kg will be performed systemically (at site that is not regional): first injection at day -14, second injection at day -7, for a total of 2 injections. | Drug | 3 |
| PEG- IFNα2bSC injections peri-lesionally (PL) in the vicinity of the primary at 3ug/kg: first injection at day -14, second injection at day -7, for a total of 2 injections. | Drug | 4 |
Primary outcome
To utilize gene-profiling analysis of regional lymph node tissue to molecularly characterize the effect of IFN α2b and PEG IFNα2b on the SLN. Endpoint: mRNA expression by gene array.
Time frame: 5
2 secondary outcomes
Quantitate putative biomarkers differentially expressed in the SLN for each active treatment group and among all active treatment groups combined. Endpoint: mRNA expression by Taqman.
Time frame: 5
Molecularly characterize the effect of perilesional IFN α2b and PEG IFNα2b administered as close as possible to the primary tumor site on SLNs that are positive vs. negative for tumor micrometastases. Endpoint: mRNA expression by gene array.
Time frame: 5
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
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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.
Ahmad Tarhini, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing IFNα2b and PEG- IFNα2b in people with Melanoma, run by University of Pittsburgh 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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 4 Aug 2017. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early. Results are not available in the source record.
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 utilize gene-profiling analysis of regional lymph node tissue to molecularly characterize the effect of IFN α2b and PEG IFNα2b on the SLN. Endpoint: mRNA expression by gene array. (time frame: 5). 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 4 Aug 2017.