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

NCT00563290 | Completed Phase 2 Results

• 7 other identifiers: NCI-2009-00226CDR0000576527OSU-07070OSU 070707813P30CA016058N01CM00070
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (Complete Response and Partial Response)

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  Every 2 courses during treatment, assessed up to 12 weeks after completion of treatment

Secondary Outcomes (3)

• Progression-free Survival

  Time from start of treatment to time of progression, assessed up to 12 weeks

• Presence of Total EphA2 and Both Total and Active Src and FAK by Immunohistochemistry (IHC)

  At baseline

• COX-2 Presence by IHC

  At baseline

Study Arms (2)

Arm I (dasatinib 100 mg PO BID)

EXPERIMENTAL

Patients receive 100 mg dasatinib PO BID on days 1-28

Drug: dasatinib; Other: laboratory biomarker analysis

Arm II (dasatinib 70 mg PO BID)

EXPERIMENTAL

Patients receive 70 mg dasatinib PO BID on days 1-28

Drug: dasatinib; Other: laboratory biomarker analysis

Interventions

dasatinib DRUG

Given PO

Also known as: BMS-354825, Sprycel

Arm I (dasatinib 100 mg PO BID); Arm II (dasatinib 70 mg PO BID)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (dasatinib 100 mg PO BID); Arm II (dasatinib 70 mg PO BID)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (3)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Skin Neoplasms; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Limitations and Caveats

3 patients were treated with Dasatinib 100 mg PO twice daily and 4 patients were treated with Daatinib 70 mg PO twice daily.

Results Point of Contact

• Title: Thomas Olencki, DO
• Organization: The Ohio State University Comprehensive Cancer Center

Thomas.Olencki@osumc.edu

614-293-2886

Study Officials

• Thomas Olencki

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2007
• First Posted: November 26, 2007
• Study Start: November 1, 2007
• Primary Completion: April 1, 2012
• Study Completion: October 1, 2014
• Last Updated: June 18, 2015
• Results First Posted: March 20, 2015

Record last verified: 2015-03

Locations

US (3)