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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015083 | U.S. NIH Grant/Contract | View source | |
| MC057F | Other Identifier | Mayo Clinic Cancer Center | |
| 06-002547 | Other Identifier | Mayo Clinic IRB | |
| NCI-2010-01794 | Registry Identifier | CTRP |
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Slow accrual.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PC (previously treated) | Experimental | Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC) |
|
| PC (chemo naive) | Experimental | Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC) |
|
| TMZ (previously treated) | Experimental | Previously chemotherapy treated cohorts: Temozolomide (TMZ) |
|
| TMZ (chemo naive) | Experimental | Chemotherapy-naive cohorts: Temozolomide (TMZ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | AUC=2 intravenously on days 1, 8 and 15. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal |
|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Disease Progression | 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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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed metastatic melanoma
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:
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 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
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| Name | Affiliation | Role |
|---|---|---|
| Svetomir Markovic, MD, PhD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
One patient canceled participation in the trial prior to starting Temozolomide therapy. This patient was excluded from all analysis.
Twelve (12) participants with un-resectable stage IV malignant melanoma were enrolled in the study between June 2006 and November 2008 at Mayo Clinic Rochester.
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| ID | Title | Description |
|---|---|---|
| FG000 | PC (Previously Treated) | Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC) |
| FG001 | PC (Chemo Naive) | Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC) |
| FG002 | TMZ (Previously Treated) | Previously chemotherapy treated cohorts: Temozolomide (TMZ) |
| FG003 | TMZ (Chemo Naive) | Chemotherapy-naive cohorts: Temozolomide (TMZ) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PC (Previously Treated) | Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC) |
| BG001 | PC (Chemo Naive) | Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | All subjects enrolled, met the eligibility criteria who have signed a consent form and have begun their study treatment were evaluable for response. | Posted | Number | participants | Every other cycle of therapy (cycle=4 weeks) for the first 6 cycles of treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TMZ (Previously Treated) | Previously chemotherapy treated cohorts: Temozolomide (TMZ) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
This trial was stopped prior to achieving its accrual goals due to slow enrollment rate. Early termination leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Svetomir N. Markovic M.D., Ph.D. | Mayo Clinic Cancer Center | 507-284-2511 | 4-2511 | markovic.svetomir@mayo.edu |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
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| paclitaxel | Drug | 100mg/m^2 intravenously on days 1, 8 and 15. Re-treat every 4 weeks until progression, unacceptable toxicity, or refusal |
|
|
| temozolomide | Drug | 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 |
|
|
| up to 2 years |
| Survival Time | Survival time was defined as the time from registration to death due to any cause. | up to 2 years |
| Duration of Response for All Evaluable Patients Who Have Achieved an Objective Response | 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. | up to 2 years |
| Number of Participants Who Experienced Changes in Immunologic Profile (CD4/CD25+ Cells, CD4/Fox-p3+ T Cells) Within a Treatment | 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. | up to 2 years |
| Number of Participants Who Experienced Changes in Immunologic Profile (MART-1, Tyrosinase, and gp100) Within a Treatment | 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. | up to 2 years |
| Number of Participants Who Experienced Changes in Immunologic Profile (IFNγ Producing Peptide Specific CTLs) Within a Treatment | 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. | up to 2 years |
| BG002 | TMZ (Previously Treated) | Previously chemotherapy treated cohorts: Temozolomide (TMZ) |
| BG003 | TMZ (Chemo Naive) | Chemotherapy-naive cohorts: Temozolomide (TMZ) |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| M Stage | M stage is based on whether the melanoma has metastasized (spread) to distant organs, which organs it has reached, and on blood levels of a substance called LDH. | Number | participants |
|
| Number of Metastatic Sites | Median | Full Range | Sites |
|
| OG001 | PC (Chemo Naive) | Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC) |
| OG002 | TMZ (Previously Treated) | Previously chemotherapy treated cohorts: Temozolomide (TMZ) |
| OG003 | TMZ (Chemo Naive) | Chemotherapy-naive cohorts: Temozolomide (TMZ) |
|
|
| Secondary | Time to Disease Progression | 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. | Posted | Median | 95% Confidence Interval | Days | up to 2 years |
|
|
|
| Secondary | Survival Time | Survival time was defined as the time from registration to death due to any cause. | Posted | Median | 95% Confidence Interval | Months | up to 2 years |
|
|
|
|
| Secondary | Duration of Response for All Evaluable Patients Who Have Achieved an Objective Response | 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. | Two complete tumor responses were documented. Both participants have since discontinued the study drug after 35 and 24 cycles respectively, and remain disease-free at 39 and 31.5 months since study entry. There is not enough participants to perform this analysis. | Posted | up to 2 years |
|
|
| Secondary | Number of Participants Who Experienced Changes in Immunologic Profile (CD4/CD25+ Cells, CD4/Fox-p3+ T Cells) Within a Treatment | 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. | There is not enough participants to perform this analysis. | Posted | up to 2 years |
|
|
| Secondary | Number of Participants Who Experienced Changes in Immunologic Profile (MART-1, Tyrosinase, and gp100) Within a Treatment | 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. | There is not enough participants to perform this analysis. | Posted | up to 2 years |
|
|
| Secondary | Number of Participants Who Experienced Changes in Immunologic Profile (IFNγ Producing Peptide Specific CTLs) Within a Treatment | 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. | There is not enough participants to perform this analysis. | Posted | up to 2 years |
|
|
| 0 |
| 2 |
| 1 |
| 2 |
| EG001 | TMZ (Chemo Naive) | Chemotherapy-naive cohorts: Temozolomide (TMZ) | 1 | 9 | 8 | 9 |
| EG002 | PC (Previously Treated) | Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC) | 0 | 0 | 0 | 0 |
| EG003 | PC (Chemo Naive) | Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC) | 0 | 0 | 0 | 0 |
| Fatigue | General disorders | MedDRA 6 | Systematic Assessment |
|
| Bronchial infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Leukopenia | Investigations | MedDRA 6 | Systematic Assessment |
|
| Lymphopenia | Investigations | MedDRA 6 | Systematic Assessment |
|
| Neutropenia | Investigations | MedDRA 6 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |