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Phase 2 N=64 Treatment

Dasatinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma

Adult Giant Cell Glioblastoma · Adult Glioblastoma · Adult Gliosarcoma · Recurrent Adult Brain Neoplasm

Enrolled (actual)
64
Serious AEs
44.0%
Results posted
Jan 2015
Primary outcome: Primary: Number of Patients Achieving 6-month Progression-free Survival (6mPFS) — 1; 2 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Dasatinib (Drug); Pharmacological Study (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
National Cancer Institute (NCI)
Primary completion
Mar 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Patients Achieving 6-month Progression-free Survival (6mPFS)
1; 2
SECONDARY
Number of Patients Achieving Objective Response (Partial or Complete Response) OR 6-month Progression-free Survival (6mPFS)
1; 2
SECONDARY
Overall Survival
6.5; 8.9
SECONDARY
Treatment Response Rates at Six Months
0.0; 0.0; 19.0; 27.6; 76.2; 69.0
SECONDARY
Progression-free Survival
1.7; 1.8
SECONDARY
Rate of Adverse Events
0.0; 10.3; 14.3; 17.2; 57.1; 44.8
SECONDARY
Correlation of Molecular Markers and Tumor Response
4; 13; 8; 23 0.99
SECONDARY
Correlation of Pharmacokinetic Data With Dosing, Toxicity, and Efficacy

Summary

This phase II trial studies how well dasatinib works in treating patients with glioblastoma multiforme or gliosarcoma that has come back. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

Inclusion Criteria

  • Histologically proven diagnosis of GBM; gliosarcoma is also an eligible diagnosis
  • The patient must consent to submission of tissue for central pathology review
  • Patients who have already undergone central pathology review through their enrollment on another Radiation Therapy Oncology Group (RTOG) GBM trial do not need to consent to having their material re-reviewed by the central pathologist for this study
  • All patients must consent to molecular analysis of pre-dasatinib tumor tissue
  • Patients accrued to stage I (closed to accrual) or stage IB (opened to accrual May 5, 2009) must have tumors overexpressing at least 2 known dasatinib targets (i.e., SRC proto-oncogene, non-receptor tyrosine kinase [SRC], v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog [KIT], platelet-derived growth factor receptor [PDGFR], or ephrin type-A receptor 2 [EPHA2])
  • Patients accrued to stage II (cohort closed; not currently applicable) do not require overexpression of SRC, KIT, PDGFR, or EPHA2
  • History and physical examination, including height and weight, within 10 days prior to registration on study
  • Brain magnetic resonance imaging (MRI) with and without gadolinium within 10 days prior to registration on study
  • Contrast-enhanced computed tomography (CT) scans are allowed for patients who cannot undergo MRI scanning
  • Karnofsky performance status >= 60
  • Absolute neutrophil count (ANC) >= 1, 000 cells/mm^3
  • Platelets >= 75,000 cells/mm^3
  • Hemoglobin (Hgb) >= 8.0 g/dl; (note: the use of transfusion or other intervention to achieve Hgb >= 8.0 g/dl is acceptable)
  • Leukocytes >= 3,000 cells/mm^3
  • Absolute lymphocyte count (ALC) >= 500 cells/mm^3
  • Total bilirubin = = 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • All patients must have undergone prior treatment with radiotherapy and temozolomide; no other prior treatments are allowed
  • There must be unequivocal radiographic evidence for tumor progression by MRI or CT scan, and the same type of scan (i.e., MRI or CT) must be used throughout the period of protocol treatment for tumor measurement; patients must be on a stable or decreasing dose of corticosteroids for at least 5 days before the baseline MRI/CT is performed
  • Patients having undergone recent surgery for recurrent/progressive disease are eligible as long as they have recovered from the effects of surgery; patients who recently underwent resection without measurable disease post-operatively are also eligible
  • Measurable disease is not required for eligibility in patients who recently underwent resection as long as the following conditions are met as applicable:
  • Progression of disease led to the surgery
  • Gliadel wafers were not placed during the most recent surgery
  • Neither convection enhanced delivery nor catheters for infusion of chemotherapy were used during the most recent surgery
  • Radioactive seeds were not placed during the most recent surgery
  • The histology of the most recent surgery documented recurrent/persistent/progressive malignant glioma
  • Women of childbearing potential must have a negative beta human chorionic gonadotropin (B HCG) pregnancy test = 480 msec (Fridericia correction)
  • Ejection fraction less than institutional normal
  • Major conduction abnormality (unless a cardiac pacemaker is present)
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; b
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00423735). 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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