A Phase 2 interventional study of carboplatin and paclitaxel in Melanoma (Skin), sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2015-12-30.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment
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.
3,073 studies on the registry are indexed under Melanoma; 529 are open to participants now.
This study's enrollment of 12 is below the median of 38 across 2,400 interventional studies indexed under Melanoma.
Browse Melanoma studies →Mayo Clinic is the lead sponsor of 3,263 studies on the registry; 670 are open to participants now.
Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed metastatic melanoma
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
At least 4 weeks since prior chemotherapy (patients who received chemotherapy in the metastatic setting)
Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
Drug: carboplatin · Drug: paclitaxel
Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
Drug: carboplatin · Drug: paclitaxel
Previously chemotherapy treated cohorts: Temozolomide (TMZ)
Drug: temozolomide
Chemotherapy-naive cohorts: Temozolomide (TMZ)
Drug: temozolomide
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
Also known as: Taxol
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
Also known as: Temodar
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.
Time frame: Every other cycle of therapy (cycle=4 weeks) for the first 6 cycles of treatment
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.
Time frame: up to 2 years
Survival Time
Survival time was defined as the time from registration to death due to any cause.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to 2 years
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.
| Milestone | PC (Previously Treated) | PC (Chemo Naive) | TMZ (Previously Treated) | TMZ (Chemo Naive) |
|---|---|---|---|---|
| Started | 0 | 0 | 2 | 9 |
| Completed | 0 | 0 | 0 | 2 |
| Not completed | 0 | 0 | 2 | 7 |
| Withdrew: Disease progression | 0 | 0 | 2 | 7 |
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.
| participants | PC (Previously Treated) | PC (Chemo Naive) | TMZ (Previously Treated) | TMZ (Chemo Naive) |
|---|---|---|---|---|
| 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 | — | — | 0 | 2 |
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.
| Days | Overall |
|---|---|
| Time to Disease Progression | 74 (68 to 132) |
Survival time was defined as the time from registration to death due to any cause.
| Months | Overall |
|---|---|
| Survival Time | 12.5 (4.5 to NA) |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TMZ (Previously Treated) | — | 0/2 (0%) | 1/2 (50%) |
| TMZ (Chemo Naive) | — | 1/9 (11.1%) | 8/9 (88.9%) |
| PC (Previously Treated) | — | — | — |
| PC (Chemo Naive) | — | — | — |
| Event | TMZ (Previously Treated) | TMZ (Chemo Naive) | PC (Previously Treated) | PC (Chemo Naive) |
|---|---|---|---|---|
| AnemiaBlood and lymphatic system disorders | 0/2 | 1/9 | — | — |
| Event | TMZ (Previously Treated) | TMZ (Chemo Naive) | PC (Previously Treated) | PC (Chemo Naive) |
|---|---|---|---|---|
| AnemiaBlood and lymphatic system disorders | 1/2 | 6/9 | — | — |
| Platelet count decreasedInvestigations | 1/2 | 4/9 | — | — |
| LeukopeniaInvestigations | 0/2 | 3/9 | — | — |
| NeutropeniaInvestigations | 0/2 | 2/9 | — | — |
| FatigueGeneral disorders | 0/2 | 1/9 | — | — |
| Bronchial infectionInfections and infestations | 0/2 | 1/9 | — | — |
| PneumoniaInfections and infestations | 0/2 | 1/9 | — | — |
| LymphopeniaInvestigations | 0/2 | 1/9 | — | — |
| MyalgiaMusculoskeletal and connective tissue disorders | 0/2 | 1/9 | — | — |
| Age, Continuous(years) | PC (Previously Treated) | PC (Chemo Naive) | TMZ (Previously Treated) | TMZ (Chemo Naive) | Total |
|---|---|---|---|---|---|
| Mean | — | — | 61.5 ± 14.85 | 63.3 ± 14.05 | 62.4 ± 12.97 |
| Gender(participants) | PC (Previously Treated) | PC (Chemo Naive) | TMZ (Previously Treated) | TMZ (Chemo Naive) | Total |
|---|---|---|---|---|---|
| Female | — | — | 0 | 3 | 3 |
| Male | — | — | 2 | 6 | 8 |
| Region of Enrollment(participants) | PC (Previously Treated) | PC (Chemo Naive) | TMZ (Previously Treated) | TMZ (Chemo Naive) | Total |
|---|---|---|---|---|---|
| United States | — | — | 2 | 9 | 11 |
| M Stage(participants) | PC (Previously Treated) | PC (Chemo Naive) | TMZ (Previously Treated) | TMZ (Chemo Naive) | Total |
|---|---|---|---|---|---|
| M1a (skin/subcutaneous tissue/lymph node only) | — | — | 0 | 1 | 1 |
| M1b (lung) | — | — | 1 | 3 | 4 |
| M1c (other visceral sites) | — | — | 1 | 5 | 6 |
| Number of Metastatic Sites(Sites) | PC (Previously Treated) | PC (Chemo Naive) | TMZ (Previously Treated) | TMZ (Chemo Naive) | Total |
|---|---|---|---|---|---|
| Median | — | — | 2 (2 to 2) | 2 (1 to 5) | 2 (1 to 5) |
This study is terminated, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Carboplatin · Paclitaxel · Temozolomide