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Tracking Information | |||||||||||||||||||||
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First Received Date † | December 5, 2007 | ||||||||||||||||||||
Last Updated Date | February 6, 2009 | ||||||||||||||||||||
Start Date † | June 2006 | ||||||||||||||||||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † | Same as current | ||||||||||||||||||||
Change History | Complete list of historical versions of study NCT00568451 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||
Brief Title † | Paclitaxel and Carboplatin or Temozolomide in Treating Patients With Stage IV Melanoma | ||||||||||||||||||||
Official Title † | Releasing the Cancer Patient's Immune System From Down-Regulation With Timed Delivery of Standard Chemotherapy | ||||||||||||||||||||
Brief Summary | RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving paclitaxel together with carboplatin is more effective than giving temozolomide alone in treating patients with melanoma. PURPOSE: This phase II trial is studying the side effects and how well giving paclitaxel together with carboplatin or giving temozolomide alone works in treating patients with stage IV melanoma. |
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Detailed Description | OBJECTIVES:
OUTLINE: Patients are stratified according to prior chemotherapy for metastatic disease (yes vs no) and scheduled chemotherapy regimen (paclitaxel and carboplatin vs temozolomide). Beginning at the predicted day of C-reactive peptide (CRP) peak levels, patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15 OR oral temozolomide alone on days 1-5. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection periodically for pharmacological studies. Samples are analyzed for CRP quantification via ELISA; presence and number of circulating blood T-regulator cells via immunophenotyping for CD4/CD25+ and CD4/fox-p3+ T cells; level of functional immunity against melanoma specific antigens (MART-1, tyrosinase, and gp100) and survivin in patients that are HLA-A2+ via intracellular staining; total number of cytotoxic T lymphocytes (CTLs) capable of reacting against melanoma targets via tetramer staining (Becton-Coulter); and quantification of interferon γ-producing, peptide-specific CTLs via multicolor conventional flow cytometry. After completion of study treatment, patients are followed every 3 months for up to 2 years. |
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Study Phase | Phase II | ||||||||||||||||||||
Study Type † | Interventional | ||||||||||||||||||||
Study Design † | Treatment, Open Label | ||||||||||||||||||||
Condition † | Melanoma (Skin) | ||||||||||||||||||||
Intervention † |
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Study Arms / Comparison Groups | |||||||||||||||||||||
Publications * | |||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||||||||||||||
Recruitment Status † | Active, not recruiting | ||||||||||||||||||||
Enrollment † | 192 | ||||||||||||||||||||
Completion Date | |||||||||||||||||||||
Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||||||||||||||||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||||||||||||||||||
Ages | 18 Years and older | ||||||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||||||
Contacts †† | |||||||||||||||||||||
Location Countries † | United States | ||||||||||||||||||||
Expanded Access Status | |||||||||||||||||||||
Administrative Information | |||||||||||||||||||||
NCT ID † | NCT00568451 | ||||||||||||||||||||
Responsible Party | |||||||||||||||||||||
Secondary IDs †† | MAYO-MC057F | ||||||||||||||||||||
Study Sponsor † | Mayo Clinic | ||||||||||||||||||||
Collaborators †† | National Cancer Institute (NCI) | ||||||||||||||||||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||||||||||||||
Verification Date | January 2009 | ||||||||||||||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |