Clinical trial NCT00871533: 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
Conditions: Melanoma
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.
Interventions:
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.
name: IFNα2b
type: Drug
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.
name: IFNα2b
type: Drug
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.
name: PEG- IFNα2b
type: Drug
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.
name: PEG- IFNα2b
type: Drug
Study arms:
design_group_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.
design_group_title: 1
design_group_type: Experimental
design_group_description: No intervention / no injection control.
design_group_title: 2
design_group_type: Experimental
design_group_description: PEG IFN INDUCTION: System PEG IFN-a2b given subcutaneously at "INDUCTION" dose level
design_group_title: 3
design_group_type: Experimental
design_group_description: REGIONAL HDI MAINTENANCE: Regional HDI given subcutaneously at "MAINTENANCE" dose level per standard HDI regimen
design_group_title: 4
design_group_type: Experimental
design_group_description: HDI Induction: Systemic HDI given intravenously at "INDUCTION" dose level per the standard HDI regimen.
design_group_title: 5
design_group_type: No Intervention
Sponsor: University of Pittsburgh
Collaborators: Schering-Plough Corp.
Drug name mappings:
name: 重组人干扰素α-2b(Merck Sharp & Dohme )
lang: CN
name: INTERFERON ALFA-2B(Merck Sharp & Dohme )
lang: EN
name: 聚乙二醇干扰素α-2b注射(Merck & Co)
lang: CN
name: Peginterferon alfa-2b(Merck & Co)
lang: EN