Stage I Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase 2 Study of Dasatinib in Patients With Transplant and Non-Transplant Related Unresectable or Metastatic Cutaneous Squamous Cell Carcinoma and RAI Stage 0-1 Chronic Lymphocytic Leukemia
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.
PRIMARY OBJECTIVES:
I. Determine the objective response rate (complete response and partial response) in
patients with unresectable or metastatic squamous cell carcinoma of the skin or RAI stage
0-I chronic lymphocytic leukemia receiving dasatinib.
SECONDARY OBJECTIVES:
I. Determine the progression-free survival of patients receiving this drug. II. Evaluate
tumor for presence of total EphA2 and both total and active Src and FAK by
immunohistochemistry (IHC) pre-treatment with dasatinib.
III. Evaluate tumor for presence of cyclooxygenase-2 by IHC pre-treatment with dasatinib.
OUTLINE: Patients are assigned to 1 of 2 treatment arms.
ARM I: Patients receive 100 mg dasatinib orally (PO) twice daily (BID) on days 1-28.
ARM II (PATIENTS ENROLLED AFTER 11/18/08): Patients receive 70 mg dasatinib PO BID on days
1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
Pre-therapy tumor biopsy specimens are collected to detect total and phosphorylated Src and
FAK, total EphA2, and cyclooxygenase-2 by immunohistochemistry.
After completion of study treatment, patients are followed up monthly for up to 12 weeks.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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