Dasatinib in Treating Patients With Unresectable or Metastatic Squamous Cell Skin Cancer or RAI Stage 0-I Chronic Lymphocytic Leukemia

Completed · Phase 2

Conditions studied: Recurrent Skin Cancer, Squamous Cell Carcinoma of the Skin, Stage 0 Chronic Lymphocytic Leukemia, Stage I Chronic Lymphocytic Leukemia

In brief

This phase II trial is studying how well dasatinib works in treating patients with unresectable or metastatic squamous cell skin cancer or RAI Stage 0-I chronic lymphocytic leukemia. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT00563290

Run by

National Cancer Institute (NCI)

People needed

7

Starts

2007-11-01

Expected to finish

2014-10-01

Last updated by the study team

2015-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of 1 of the following
• Histologically or cytologically confirmed squamous cell carcinoma of the skin
• Unresectable or metastatic disease
• Squamous cell histology represents ≥ 50% of the biopsy specimen
• May or may not be related to autologous or allogeneic organ transplantation
• Chronic lymphocytic leukemia (CLL)
• RAI stage 0-I
• Stable disease
• Patients with basalosquamous cell disease (basal cell with squamous differentiation) are eligible
• Measurable disease, defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• Must be willing to undergo a pre-treatment tumor biopsy
• Brain metastases are allowed provided the following are true:
• Received definitive therapy consisting of external beam radiation therapy, gamma knife therapy, or surgical resection resulting in clinically stable disease
• Lesions are under control for at least 4 weeks after completion of definitive therapy, as measured by repeat MRI or CT scans
• No requirement for dexamethasone
• ECOG performance status 0-1 OR Karnofsky 60-100%
• Life expectancy > 6 months
• WBC ≥ 3,000/mm\^3
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelets ≥ 100,000/mm\^3
• Total bilirubin ≤ 1.5 times upper limit of normal(ULN)
• AST/ALT ≤ 2.5 times ULN
• Potassium 3.5 - 5.1 mmol/L
• Calcium > lower limit of normal
• Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.