Paclitaxel and Carboplatin or Temozolomide in Treating Patients With Stage IV Melanoma - Full Text View

Sponsors and Collaborators:	Mayo Clinic National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00568451

Purpose

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.

Condition	Intervention	Phase
Melanoma (Skin)	Drug: carboplatin Drug: paclitaxel Drug: temozolomide Procedure: flow cytometry Procedure: immunoenzyme technique Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: pharmacological study	Phase II

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Carboplatin Temozolomide Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Releasing the Cancer Patient's Immune System From Down-Regulation With Timed Delivery of Standard Chemotherapy

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Objective response rate [ Designated as safety issue: No ]
Toxicity profile [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time to disease progression [ Designated as safety issue: No ]
Duration of response [ Designated as safety issue: No ]
Survival time [ Designated as safety issue: No ]
Changes in immunologic profile within a treatment [ Designated as safety issue: No ]

Estimated Enrollment:	192
Study Start Date:	June 2006
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

To assess the anti-tumor activity and toxicity profile of timed delivery of conventional paclitaxel and carboplatin (PC) in patients with stage IV melanoma who have received prior chemotherapy for their metastatic disease.
To assess the anti-tumor activity and toxicity profile of timed delivery of conventional temozolomide (TMZ) chemotherapy in patients with stage IV melanoma who have received prior chemotherapy for their metastatic disease.
To assess the anti-tumor activity and toxicity profile of timed delivery of conventional PC in patients with stage IV melanoma who have not received prior chemotherapy for their metastatic disease.
To assess the anti-tumor activity and toxicity profile of timed delivery of conventional TMZ chemotherapy in patients with stage IV melanoma who have not received prior chemotherapy for their metastatic disease.
To evaluate the changes of T-regulator cells, melanoma-specific functional parameters as a function of time in all four patient cohorts.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed metastatic melanoma
- Stage IV disease
- Progressive disease
- No known standard therapy that is potentially curative or proven capable of extending life expectancy exists
Planning to undergo chemotherapy with paclitaxel and carboplatin OR temozolomide alone for progressive disease
Measurable disease as defined by RECIST criteria

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Life expectancy ≥ 3 months
ANC ≥ 1,500/mL
Platelet count ≥ 100,000/mL
Hemoglobin ≥ 9 g/dL
Creatinine ≤ 2.5 x upper limit of normal (ULN)
AST ≤ 3 x ULN
Alkaline phosphatase ≤ 3.0 x ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 1 month after completion of study therapy
No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Active infection
- NYHA class III or IV congestive heart failure
No history of other malignancy within the past 5 years except for basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
Willing to provide research blood samples

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Recovered from prior therapy
At least 4 weeks since prior radiotherapy
At least 4 weeks since prior chemotherapy (patients who received chemotherapy in the metastatic setting)
- No prior chemotherapy treatment with agents similar to study drugs
No prior chemotherapy in the metastatic setting (for chemo-naive patients)
No concurrent enrollment in a different clinical study in which investigational procedures or agents are being used
No other concurrent investigational agents
No other concurrent chemotherapy or radiotherapy, including palliative radiotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568451

Locations

United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Study Chair:	Svetomir Markovic, MD, PhD	Mayo Clinic
Investigator:	Edward T. Creagan, MD	Mayo Clinic
Investigator:	Judith S. Kaur, MD	Mayo Clinic
Investigator:	Ravi D. Rao, MD, MBBS	Mayo Clinic
Investigator:	Robert McWilliams, MD	Mayo Clinic

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000578996, MAYO-MC057F
Study First Received:	December 5, 2007
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00568451
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:

Neuroectodermal Tumors
Paclitaxel
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Carboplatin

Nevus
Temozolomide
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions

Neoplasms
Therapeutic Uses
Tubulin Modulators
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 15, 2009