Paclitaxel and Carboplatin or Temozolomide in Treating Patients With Stage IV Melanoma
| Status: | Terminated |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 4/21/2016 |
| Start Date: | June 2006 |
| End Date: | April 2012 |
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.
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:
- 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.
- 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.
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
We found this trial at
1
site
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
Click here to add this to my saved trials
