Dasatinib, Temsirolimus, and Cyclophosphamide in Treating Patients With Advanced, Recurrent, or Refractory Solid Tumors
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|ClinicalTrials.gov Identifier: NCT02389309|
Recruitment Status : Recruiting
First Posted : March 17, 2015
Last Update Posted : January 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignant Solid Neoplasm Recurrent Brain Neoplasm Recurrent Malignant Solid Neoplasm Refractory Brain Neoplasm||Drug: Cyclophosphamide Drug: Dasatinib Other: Laboratory Biomarker Analysis Drug: Temsirolimus||Phase 1|
I. To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of combination treatment with dasatinib, cyclophosphamide and temsirolimus.
II. To define and describe the toxicities of the combination of dasatinib, cyclophosphamide and temsirolimus administered on this schedule.
I. To preliminarily define the antitumor activity of the combination of dasatinib, cyclophosphamide and temsirolimus within the confines of a phase 1 study.
II. Preliminary assessment of biological markers and correlates of response.
OUTLINE: This is a dose-escalation study of dasatinib and temsirolimus.
Patients receive dasatinib orally (PO) twice daily (BID) on days 1-21, cyclophosphamide PO once daily (QD) on days 1-21, and temsirolimus intravenously (IV) over 30-60 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing stable disease or better may continue treatment with the approval of the study chair.
After completion of study treatment, patients are followed up for 4 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Dasatinib (PDGFR and SRC Inhibitor), Temsirolimus, and Cyclophosphamide in Patients With Advanced Solid Tumors|
|Actual Study Start Date :||October 5, 2015|
|Estimated Primary Completion Date :||October 31, 2021|
|Estimated Study Completion Date :||October 31, 2021|
Experimental: Treatment (dasatinib, cyclophosphamide, temsirolimus)
Patients receive dasatinib PO BID on days 1-21, cyclophosphamide PO QD on days 1-21, and temsirolimus IV over 30-60 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing stable disease or better may continue treatment with the approval of the Study Chair.
Other: Laboratory Biomarker Analysis
- Maximum tolerated dose (MTD) defined as the highest dose level tested at which =< 2/6 patients experience dose limiting toxicities (DLT) graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTCAE) version 4.0 [ Time Frame: Up to day 35 ]
- Incidence of adverse events (AEs) graded according to NCI CTCAE version 4.0 [ Time Frame: Up to 28 days post-treatment ]AEs will be tabulated by dose, grade, and attribution.
- Best response (complete response [CR], partial response [PR], stable disease [SD], and progressive disease [PD]) using the Response Evaluation Criteria in Solid Tumors from the NCI for assessment of radiographic response [ Time Frame: Up to 4 weeks post-treatment ]Tabulated by dose and disease category (CR, PR, SD, and PD).
- Levels of biological markers measured in tissue, blood, or plasma [ Time Frame: Up to 4 weeks post-treatment ]Correlation of biomarkers between tissue and blood will be assessed. The association among various continuous and discrete variables (including response variable) will be assessed first by the exploratory data analysis graphically and then tested using t-test/analysis of variance or Wilcoxon rank sum test/Kruskal-Wallis test, when appropriate. Correlation among continuous biomarkers will be examined by Pearson or Spearman rank correlation coefficients. The association between discrete variables will be tested by chi-square or Fisher's exact test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389309
|Contact: Wafik Zaky, MBBCH||713-792-6620||WZaky@mdanderson.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Wafik T. Zaky 713-792-6620 firstname.lastname@example.org|
|Principal Investigator: Wafik T. Zaky|
|Principal Investigator:||Wafik T Zaky||M.D. Anderson Cancer Center|