Phase II trial of nab-paclitaxel for the treatment of desmoid tumors and multiply relapsed/refractory desmoplastic small round cell tumors and Ewing sarcoma - ABRADES

Grupo Español de Investigación en Sarcomas (GEIS)0 sites61 target enrollmentDecember 27, 2016

DrugsAbraxane

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Grupo Español de Investigación en Sarcomas (GEIS)
Enrollment: 61
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 27, 2016

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Grupo Español de Investigación en Sarcomas (GEIS)

Eligibility Criteria

Inclusion Criteria

•Cohort 1: Desmoid tumor
•1\. Subjects must voluntarily sign the informed consent form before any study test is conducted that is not part of routine subject care.
•2\. Subjects with pathologic diagnosis of deep desmoid tumor of extremities, trunk wall or head and neck region.
•3\. Subjects must be symptomatic due to tumor desmoid mass.
•4\. Age: 18\-80 years (both ages included).
•5\. Subjects could have received 1 previous chemotherapy line if the scheme was methrotrexate and vinca alkaloids. Importantly, if this is the case, it must be documented that symptoms have gotten worse or simptoms are stable in the context of disease progression (RECIST 1\.1\).
•6\. Availability of archive tumor block.
•7\. Measurable disease, according to RECIST 1\.1 criteria.
•8\. Performance status \=1 (ECOG).
•9\. Adequate respiratory functions: FEV1 \> 1L.

Exclusion Criteria

•Cohort 1: Desmoid tumor
•1\. Less than 4 weeks elapsed since prior exposure to chemotherapy. 2\. Subjects with desmoid tumor of abdominal cavity (abdominal wall is not an exclusion criteria) 3\. Desmoid tumor with ill\-defined margins. 4\. Unavailability to undergo MRI. 5\. Previously irradiated target lesion. 6\. Pre\-existing neuropathy greater than grade 1\. 7\. Other active invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years. However, localized squamous cell carcinoma of the skin, basal cell carcinoma of the skin, carcinoma in situ of the cervix or other malignancies requiring only locally ablative therapy, will not result in exclusion. 8\. Concomitant anticancer therapy, immunotherapy or radiation therapy within prior 4 weeks. 9\. Uncontrolled intercurrent illness including but not limited to ongoing or active infection requiring IV antibiotic, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness or social situations that would limit compliance with study requirements 10\. Hb \< 9 g/dL. 11\. Pregnant women are excluded due to the potential for teratogenic or abortifacient effects of nab paclitaxel because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued prior to participation of the mother on study. 12\. Known hypersensitivity to protein bound paclitaxel 13\. Any other concurrent condition that in the investigators opinion would jeopardize compliance with the protocol
•14\. Known positive test for infection by human immunodeficiency virus (HIV).
•15\. Subjects participating in another clinical trial or receiving any other investigational product.
•Cohort 2: DSRCT and ES
•1\. Less than 4 weeks elapsed since prior exposure to chemotherapy.
•2\. Pre\-existing neuropathy greater than Grade 1\.
•3\. Other active invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years. However, localized squamous cell carcinoma of the skin, basal cell carcinoma of the skin, carcinoma in situ of the cervix or other malignancies requiring only locally ablative therapy, will not result in exclusion.
•4\. Concomitant anticancer therapy, immunotherapy or radiation therapy within prior 4 weeks.
•5\. Uncontrolled intercurrent illness including but not limited to ongoing or active infection requiring IV antibiotic, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness or social situations that would limit compliance with study requirements