- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00568451
Paclitaxel and Carboplatin or Temozolomide in Treating Patients With Stage IV Melanoma
Releasing the Cancer Patient's Immune System From Down-regulation With Timed Delivery of Standard Chemotherapy
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PC (previously treated)
Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
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AUC=2 intravenously on days 1, 8 and 15.
Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal
100mg/m^2 intravenously on days 1, 8 and 15.
Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal
Other Names:
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Experimental: PC (chemo naive)
Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
|
AUC=2 intravenously on days 1, 8 and 15.
Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal
100mg/m^2 intravenously on days 1, 8 and 15.
Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal
Other Names:
|
Experimental: TMZ (previously treated)
Previously chemotherapy treated cohorts: Temozolomide (TMZ)
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150mg/m^2 at cycle 1, 200mg/m^2 at cycle 2 and beyond, orally on days 1-5.
Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal.
One treatment cycle=four weeks
Other Names:
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Experimental: TMZ (chemo naive)
Chemotherapy-naive cohorts: Temozolomide (TMZ)
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150mg/m^2 at cycle 1, 200mg/m^2 at cycle 2 and beyond, orally on days 1-5.
Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal.
One treatment cycle=four weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With an Objective Tumor Status of Either a Complete Response(CR) or Partial Response (PR), According to RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Time Frame: Every other cycle of therapy (cycle=4 weeks) for the first 6 cycles of treatment
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Response that was noted on 2 consecutive evaluations for at least 4 weeks apart. CR: Disappearance of all target lesions; PR: At least a 30 percent of decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Target lesions: All measurable lesions up to a maximum of 10 lesions representative of all involved organs. |
Every other cycle of therapy (cycle=4 weeks) for the first 6 cycles of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Disease Progression
Time Frame: up to 2 years
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Time to disease progression was defined as the time from registration to documentation of disease progression.
Disease progression was measured according to the RECIST criteria.
Progression: At least a 20 percent increase in the sum of of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
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up to 2 years
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Survival Time
Time Frame: up to 2 years
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Survival time was defined as the time from registration to death due to any cause.
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up to 2 years
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Duration of Response for All Evaluable Patients Who Have Achieved an Objective Response
Time Frame: up to 2 years
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Duration of response was defined as the date at which the participant's objective status was first noted to be either a Complete Response or Partial Response to the date the progression was documented.
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up to 2 years
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Number of Participants Who Experienced Changes in Immunologic Profile (CD4/CD25+ Cells, CD4/Fox-p3+ T Cells) Within a Treatment
Time Frame: up to 2 years
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Time series plot of the number of circulating cells will be constructed.
The resulting plots will be visually inspected for trends within and between treatments.
For each cell type, a point and an interval estimate of the number of participants (receiving a given treatment) who had at least a 2-fold increase in the number of circulating cells of that type will be constructed using the properties of the binomial distribution.
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up to 2 years
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Number of Participants Who Experienced Changes in Immunologic Profile (MART-1, Tyrosinase, and gp100) Within a Treatment
Time Frame: up to 2 years
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For those patients who are HLA-A2+, the maximum post-treatment levels of MART-1, tyrosinase, and gp100 will be determined.
For each of these specific melanoma specific antigens, the number of participants (within a given treatment) who gained or maintained immunity based on the maximum post-treatment level of that specific melanoma specific antigen will be determined.
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up to 2 years
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Number of Participants Who Experienced Changes in Immunologic Profile (IFNγ Producing Peptide Specific CTLs) Within a Treatment
Time Frame: up to 2 years
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For each patient, a time series plot of the number of IFNγ producing peptide specific CTLs will be constructed.
The resulting plots will be visually inspected for trends within and between treatments.
A point and an interval estimate of the number of participants (receiving a given treatment) who had at least a 2-fold increase in the number of the number of IFNγ producing peptide specific CTLs will be constructed using the properties of the binomial distribution.
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up to 2 years
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
- Temozolomide
Other Study ID Numbers
- MC057F (Other Identifier: Mayo Clinic Cancer Center)
- P30CA015083 (U.S. NIH Grant/Contract)
- 06-002547 (Other Identifier: Mayo Clinic IRB)
- NCI-2010-01794 (Registry Identifier: CTRP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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