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NCT00525031 · ClinicalTrials.gov registry record · Phase 2
Temozolomide Alone or With Pegylated Interferon-Alpha 2b (PGI) in Melanoma Patients
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT00525031: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00525031 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 55 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00525031, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if temozolomide alone or given with pegylated interferon alpha-2b can help to control metastatic melanoma. Researchers also want to study the safety of these 2 treatments. Objectives: 1. To determine the anti-tumor activity (pathological response CR+PR) and toxicity of temozolomide (TMZ) alone or in combination with pegylated interferon alpha-2b (PGI) in patients with resectable stage IIIC or stage IV (M1a) metastatic melanoma prior to definitive surgical resection. 2. To determine the relapse-free survival, overall survival and the impact of tumor response to chemotherapy in these patients. 3. To differentiate the in vivo treatment effects of TMZ alone vs.TMZ plus PGI and correlate with clinical outcome by analysis the pre- and post-treatment tumors and peripheral blood mononuclear cells with respect to: 1\) Known cellular and molecular markers of apoptosis and cell proliferation, 2) Promotor methylation status of the DNA repair enzyme O6-methylguanine-DNA methyltransferase (MGMT), 3) DNA sequence variability of tumor suppressor genes and DNA repair enzymes, 4) Tumor genomic expression profiles analysis by complementary DNA (cDNA) microarray and protein array
Interventions
- DRUG Temozolomide (TMZ)
- DRUG Pegylated Interferon Alpha-2b (PGI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2006-08 |
| Est. Completion | 2016-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00525031
The ClinicalTrials.gov registry entry for NCT00525031 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Temozolomide (TMZ) is the first listed.
NCT00525031 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00525031 about?
NCT00525031 is a clinical study titled "Temozolomide Alone or With Pegylated Interferon-Alpha 2b (PGI) in Melanoma Patients". The goal of this clinical research study is to learn if temozolomide alone or given with pegylated interferon alpha-2b can help to control metastatic melanoma. Researchers also want to study the safety of these 2 treatments. Objectives: 1. To determine the anti-tumor activity (pathological respons...
What is the current status of trial NCT00525031?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2006-08. Estimated completion is 2016-06.
What interventions are being tested in trial NCT00525031?
The interventions under investigation include: Temozolomide (TMZ) (DRUG), Pegylated Interferon Alpha-2b (PGI) (DRUG).
Who is sponsoring clinical trial NCT00525031?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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