Pilot Study of IFN α2b for Melanoma Patients
| Status: | Terminated |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/5/2017 |
| Start Date: | September 2009 |
| End Date: | August 2017 |
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.
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.
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.
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