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NCT00871533 · ClinicalTrials.gov registry record · Early Phase 1
Pilot Study of IFN α2b for Melanoma Patients
A Early Phase 1 study, sponsored by University of Pittsburgh.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 50
- Enrollment target
NCT00871533 is a Early Phase 1 study that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 50 participants.
The verdict
NCT00871533, a Early Phase 1 study, was terminated before completion, sponsored by University of Pittsburgh.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 50 participants
- Enrollment target
Study 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
- DRUG IFNα2b
- DRUG PEG- IFNα2b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2009-09 |
| Est. Completion | 2017-08 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00871533
The ClinicalTrials.gov registry entry for NCT00871533 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which IFNα2b is the first listed.
NCT00871533 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00871533 about?
NCT00871533 is a clinical study titled "Pilot Study of IFN α2b for Melanoma Patients". 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...
What is the current status of trial NCT00871533?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 50 participants. The study started on 2009-09. Estimated completion is 2017-08.
What interventions are being tested in trial NCT00871533?
The interventions under investigation include: IFNα2b (DRUG), PEG- IFNα2b (DRUG).
Who is sponsoring clinical trial NCT00871533?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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