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Pilot Study of IFN α2b for Melanoma Patients

Primary Purpose

Melanoma

Status

Terminated

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

IFNα2b

PEG- IFNα2b

About this trial

This is an interventional diagnostic trial for Melanoma focused on measuring 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, Markers, Biochemical, Markers, Biological, Markers, Clinical, Markers, Immunologic, Markers, Laboratory, Markers, Serum, Markers, Surrogate, Markers, Viral, Serum Marker, Serum Markers, Surrogate End Point, Surrogate End Points, Surrogate Endpoint, Surrogate Endpoints, Surrogate Marker, Surrogate Markers, Viral Marker, Viral Markers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

UPMC Hillman Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

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.

No intervention / no injection control.

PEG IFN INDUCTION: System PEG IFN-a2b given subcutaneously at "INDUCTION" dose level

REGIONAL HDI MAINTENANCE: Regional HDI given subcutaneously at "MAINTENANCE" dose level per standard HDI regimen

HDI Induction: Systemic HDI given intravenously at "INDUCTION" dose level per the standard HDI regimen.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT00871533

First Posted

March 26, 2009

Last Updated

August 3, 2017

Sponsor

University of Pittsburgh

Collaborators

Schering-Plough

1. Study Identification

Unique Protocol Identification Number

NCT00871533

Brief Title

Pilot Study of IFN α2b for Melanoma Patients

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Terminated

Study Start Date

September 2009 (undefined)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

Collaborators

Schering-Plough

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

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, Markers, Biochemical, Markers, Biological, Markers, Clinical, Markers, Immunologic, Markers, Laboratory, Markers, Serum, Markers, Surrogate, Markers, Viral, Serum Marker, Serum Markers, Surrogate End Point, Surrogate End Points, Surrogate Endpoint, Surrogate Endpoints, Surrogate Marker, Surrogate Markers, Viral Marker, Viral Markers

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

Experimental

Arm Description

No intervention / no injection control.

Arm Title

Arm Type

Experimental

Arm Description

PEG IFN INDUCTION: System PEG IFN-a2b given subcutaneously at "INDUCTION" dose level

Arm Title

Arm Type

Experimental

Arm Description

REGIONAL HDI MAINTENANCE: Regional HDI given subcutaneously at "MAINTENANCE" dose level per standard HDI regimen

Arm Title

Arm Type

No Intervention

Arm Description

HDI Induction: Systemic HDI given intravenously at "INDUCTION" dose level per the standard HDI regimen.

Intervention Type

Drug

Intervention Name(s)

IFNα2b

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

IFNα2b

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

PEG- IFNα2b

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

PEG- IFNα2b

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmad Tarhini, MD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

UPMC Hillman Cancer Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

12. IPD Sharing Statement

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Pilot Study of IFN α2b for Melanoma Patients

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