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Alkylating Agent

Dasatinib for Cancer

Phase 1
Waitlist Available
Led By Wafik T Zaky
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 35
Awards & highlights

Study Summary

This trial is studying dasatinib, temsirolimus, and cyclophosphamide to treat patients with solid tumors.

Who is the study for?
This trial is for patients under 21 with advanced solid tumors, including brain tumors, that have spread or not responded to treatment. They must have proper liver and kidney function, stable neurological status if they have brain tumors, and a life expectancy of at least 12 weeks. Patients should not be pregnant or breastfeeding, HIV positive, or have had certain recent health issues like heart disease.Check my eligibility
What is being tested?
The trial tests the combination of dasatinib and temsirolimus with cyclophosphamide in patients with recurrent or resistant solid tumors. It aims to find the safest doses and observe how these drugs might stop tumor growth by inhibiting specific enzymes needed for cell division.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's response to the drugs, possible damage to organs due to inflammation caused by drug interactions within cells, blood disorders from chemotherapy agents affecting bone marrow function, fatigue from overall body stress due to treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 35
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 35 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (AEs) graded according to NCI CTCAE version 4.0
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
Secondary outcome measures
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
Levels of biological markers measured in tissue, blood, or plasma

Side effects data

From 2022 Phase 2 trial • 54 Patients • NCT03023046
26%
Febrile neutropenia
17%
Sepsis
9%
Mucositis oral
4%
Upper gastrointestinal hemorrhage
4%
Intracranial hemorrhage
4%
Hypotension
4%
Hypertension
4%
Enterocolitis
2%
Atrial fibrillation
2%
Lower gastrointestinal hemorrhage
2%
Delirium
2%
Oropharyngeal pain
2%
Gastric hemorrhage
2%
Abdominal pain
2%
Diarrhea
2%
Fungemia
2%
Typhlitis
2%
Myocardial infarction
2%
Fibrinogen decreased
2%
Endophthalmitis
2%
Multi-organ failure
2%
Kidney infection
2%
Peripheral motor neuropathy
2%
Hypoxia
2%
Sinus bradycardia
2%
Edema limbs
2%
Small intestinal obstruction
2%
Aspiration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (dasatinib, cyclophosphamide, temsirolimus)Experimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sirolimus
FDA approved
Cyclophosphamide
FDA approved
Dasatinib
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,202 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,475 Total Patients Enrolled
Wafik T ZakyPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
18 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Dasatinib, Temsirolimus, and Cyclophosphamide in Treating Patients With Advanced, Recurrent, or Refractory Solid Tumors
2015. "Dasatinib, Temsirolimus, and Cyclophosphamide in Treating Patients With Advanced, Recurrent, or Refractory Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02389309.
All > Brain Cancer > Dasatinib
~1 spots leftby Oct 2024
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