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Phase 2 N=7 Treatment

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

Recurrent Skin Cancer · Squamous Cell Carcinoma of the Skin · Stage 0 Chronic Lymphocytic Leukemia · Stage I Chronic Lymphocytic Leukemia

Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Objective Response Rate (Complete Response and Partial Response) — 0; 0 percentage of patients

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
dasatinib (Drug); laboratory biomarker analysis (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
National Cancer Institute (NCI)
Primary completion
Apr 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Objective Response Rate (Complete Response and Partial Response)
0; 0
SECONDARY
Progression-free Survival
4
SECONDARY
Presence of Total EphA2 and Both Total and Active Src and FAK by Immunohistochemistry (IHC)
SECONDARY
COX-2 Presence by IHC

Summary

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.

Eligibility Criteria

Inclusion Criteria

  • 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
  • No known HIV 1 or HIV 2 positivity
  • No known hepatitis C or hepatitis B positivity
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to dasatinib
  • No QTc prolongation, defined as a QTc interval of ≥ 480 msecs or other significant ECG abnormality
  • No condition that impairs the ability to swallow and retain dasatinib tablets (e.g., gastrointestinal tract disease resulting in an inability to take oral medication, requirement for IV alimentation, prior surgical procedure affecting absorption, or active peptic ulcer disease)
  • No clinically significant cardiovascular disease including the following:
  • Myocardial infarction within 6 months
  • Uncontrolled angina within 3 months
  • Diagnosed or suspected congenital long QT syndrome
  • Any history of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or Torsades de Pointe)
  • Any history of second or third degree heart block (may be eligible if the subject currently has a pacemaker)
  • Heart rate consistently < 50 beats/minute on pre-entry ECG
  • Uncontrolled hypertension
  • Ejection fraction < 45% by transthoracic echo
  • No uncontrolled intercurrent illness including, but not limited to, the following:
  • Ongoing or active infection requiring intravenous antibiotics
  • History of significant bleeding disorder, including congenital (von Willebrand's disease) or acquired (anti-factor VIII antibodies) disorders
  • Psychiatric illness or social situations that would limit compliance with study requirements
  • No prior malignancy except for adequately treated basal cell cancer, carcinoma in situ of the cervix, or other cancer for which the patient has been disease free for 3 years
  • No gastro-esophageal reflux disease dependent on proton pump inhibitors, H2 blockers, or antacids
  • Recovered from prior therapy
  • No more than 1 prior therapy with a monoclonal antibody
  • No more than 1 prior chemotherapy regimen
  • No prior tyrosine kinase inhibitor therapy
  • Prior erlotinib hydrochloride allowed
  • More than 2 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
  • At least 4 weeks since prior radiotherapy
  • Measurable disease must be outside the radiotherapy port
  • At least 2 weeks since prior topical therapy
  • At least 4 weeks since prior surgery requiring general anesthesia and intubation
  • At least 120 days (4 months) since
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00563290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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