Know Cancer

or
forgot password

Releasing the Cancer Patient's Immune System From Down-regulation With Timed Delivery of Standard Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

Thank you

Trial Information

Releasing the Cancer Patient's Immune System From Down-regulation With Timed Delivery of Standard Chemotherapy


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Every other cycle of therapy (cycle=4 weeks) for the first 6 cycles of treatment

Safety Issue:

No

Principal Investigator

Svetomir Markovic, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000578996

NCT ID:

NCT00568451

Start Date:

June 2006

Completion Date:

December 2011

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905