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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02689336
Other study ID # 201604002
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date August 6, 2016
Est. completion date May 31, 2020

Study information

Verified date September 2019
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study proposes to treat patients with the combination of erlotinib and temozolomide. Patients with relapsed, recurrent, refractory, or high risk malignancies whose tumors possess a non-synonymous mutation in EGFR, ERBB2, or JAK2V617F (JAK2) will be eligible for the study. Very few phase 2 clinical trials have been performed in pediatrics using targeted agents in combination with conventional chemotherapy agents. Furthermore, since some combinations such as the combination of this study (erlotinib and temozolomide) have shown additive/synergistic effects in preclinical studies, therapy selecting for those patients who possess mutations targeted by the TKI of the study, may unveil activity that has not been previously observed. Thus, the investigators hope to determine whether the addition of additive/synergistic chemotherapy will increase efficacy of target agent and/or increase tumor susceptibility to targeted agent resulting in increased anti-tumor activity.


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Study Design


Intervention

Biological:
Erlotinib

Drug:
Temozolomide


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Outcome

Type Measure Description Time frame Safety issue
Primary Overall response rate The overall response rate is the proportion of patients who have complete response or partial response
Complete Response (CR): Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Completion of treatment (estimated to be 6 months)
Secondary Time to progression --Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). 1 year
Secondary Toxicities of treatment regimen -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. 30 days after completion of treatment (estimated to be 7 months)
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