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Trial of Nab-paclitaxel in Patients With Desmoid Tumors and Multiply Relapsed/Refractory Desmoplastic Small Round Cell Tumors and Ewing Sarcoma (ABRADES)

This study is currently recruiting participants.
Verified September 2017 by Grupo Espanol de Investigacion en Sarcomas
Sponsor:
ClinicalTrials.gov Identifier:
NCT03275818
First Posted: September 8, 2017
Last Update Posted: September 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Grupo Espanol de Investigacion en Sarcomas
August 3, 2017
September 8, 2017
September 8, 2017
May 9, 2017
September 30, 2020   (Final data collection date for primary outcome measure)
  • Objective response rate (ORR) - cohort 1 [ Time Frame: 3 months ]
    TD cohort: Objective response rate (ORR) (confirmed complete response [CR] and partial response [PR]), measured using RECIST 1.1 criteria. Response criteria will be based on the baseline identification of target lesions
  • Clinical benefit rate (CBR) - cohort 1 [ Time Frame: 3 months ]
    TD cohort: Clinical benefit rate (CBR) measured as CR+PR+SD for 3 months with improvement of pain with at least minimally important difference (MID) of 2
  • Objective response rate (ORR) - cohort 2 [ Time Frame: 2 months ]
    DSRCT and SE cohort: Objective response rate (ORR) (confirmed complete response [CR] and partial response [PR]), measured using RECIST 1.1 criteria. Response criteria will be based on the baseline identification of target lesions and radiological assessments every 3 months until tumor progression
Same as current
No Changes Posted
  • Pattern of radiological response - cohort 1 [ Time Frame: 3 months ]
    TD cohort: To define the pattern of radiological response according to MRI parameters and to correlate it with CBR and Brief Pain Inventory (BPI) parameters.
  • Progression-free survival - cohort 1 [ Time Frame: 3 months ]
    TD cohort: To estimate the efficacy of nab-paclitaxel as measured by the progression-free survival (PFS) assessed by median time.
  • Variation of symptoms - cohort 1 [ Time Frame: during first year ]
    TD cohort: To analyze the variation of symptoms during the first year from trial enrollment in accordance with BPI and Analgesic Quantification Algorithm (AQA).
  • Safety profile of nab-paclitaxel - cohort 1 [ Time Frame: up to 12 months ]
    TD cohort: To evaluate the safety profile of nab-paclitaxel according to CTCAE 4.0.
  • Safety profile of nab-paclitaxel - cohort 2 [ Time Frame: up to 12 months ]
    DSRCT and SE cohort: To evaluate the safety profile of nab-paclitaxel according to CTCAE 4.0.
Same as current
Not Provided
Not Provided
 
Trial of Nab-paclitaxel in Patients With Desmoid Tumors and Multiply Relapsed/Refractory Desmoplastic Small Round Cell Tumors and Ewing Sarcoma
Phase II Trial of Nab-paclitaxel for the Treatment of Desmoid Tumors and Multiply Relapsed/Refractory Desmoplastic Small Round Cell Tumors and Ewing Sarcoma

A two-cohort, fase II, open-label, non-randomized, multicenter clinical trial. 14 sites in Spain.

Cohort 1: Subjects with desmoid tumor (DT) Cohort 2: Subjects with desmoplastic small round cell tumor or Ewing sarcoma (DSRCT and ES)

Nab-paclitaxel (ABRAXANE) will be administered as follows:

Age ≥ 21 and ≤ 80 years: 125 mg/m2 days 1, 8 and 15 in cycles of 28 days Age ≥ 6 months and ≤ 20 years: 240 mg/m2 days 1, 8 and 15 in cycles of 28 days

Subjects in the DT cohort will receive a maximum of three cycles. Subjects in the DSRCT and ES cohort will receive unlimited cycles until disease progression, the subject begins a new anticancer treatment, withdrawal of parent/guardian/subject consent/assent, parent/guardian/subject refusal, physician decision, toxicity that cannot be managed by dose delay or dose reduction alone or the study ends for any reason.

The main goal is to determine the objective response rate (ORR), using RECIST 1.1 criteria and to determine the clinical benefit rate (CBR), defined as CR+PR+SD for 3 months with improvement of pain with at least minimally important difference (MID) of 2 in subjects with desmoid tumors (DT cohort) and to determine the objective response rate (ORR) in subjects with desmoplastic small round cell tumor and Ewing sarcoma, using RECIST 1.1 criteria (DSRCT and ES cohort)

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Tumor, Desmoplastic Small Round Cell, Adult
  • Tumor, Desmoplastic Small Round Cell, Childhood
  • Sarcoma, Ewing
  • Sarcoma
  • Desmoid
Drug: nab paclitaxel
Subjects in the DT cohort will receive a maximum of three cycles. Subjects in the DSRCT and ES cohort will receive unlimited cycles until disease progression, the subject begins a new anticancer treatment, withdrawal of parent/guardian/subject consent/assent, parent/guardian/subject refusal, physician decision, toxicity that cannot be managed by dose delay or dose reduction alone or the study ends for any reason
Other Name: Abraxane
Experimental: nab-paclitaxel

nab-paclitaxel (ABRAXANE) will be administered as follows:

  • Age ≥ 21 and ≤ 80 years: 125 mg/m2 days 1, 8 and 15 in cycles of 28 days
  • Age ≥ 6 months and ≤ 20 years: 240 mg/m2 days 1, 8 and 15 in cycles of 28 days
Intervention: Drug: nab paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
61
September 30, 2020
September 30, 2020   (Final data collection date for primary outcome measure)

TD Cohort

Inclusion Criteria:

  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 methotrexate and vinca alkaloids. Importantly, if this is the case, it must be documented that symptoms have gotten worse or symptoms 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.
  10. Normal ECG values.
  11. Adequate bone marrow function (hemoglobin ≥ 9 g/dL, leukocytes ≥ 3.000/mm3, neutrophils ≥ 1.500/mm3, platelets ≥ 100.000/mm3). Subjects with plasma creatinine ≤ 1.6 mg/dl, transaminases ≤ 10 times the ULN, total bilirubin ≤ 1.25 times the ULN are acceptable.
  12. Men or women of childbearing potential must use an effective method of contraception before entry into the study and throughout the same and for 6 months after ending the study treatment. Women of childbearing potential must have a negative urine or serum pregnancy test before study entry.
  13. HBV and HCV serologies must be performed prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+) remaining at investigators' discretion the preventive treatment with lamivudine. If a potential subject is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the subject should NOT be included in the study (if a qualitative PCR cannot be performed then subject will not be able to enter the study).

Exclusion Criteria:

  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.

DSRCT and ES Cohort

Inclusion Criteria:

  1. Subjects (parent or tutor if subject under 18 years) must voluntarily sign the informed consent form before any study test is conducted that is not part of routine subject care.
  2. Subject diagnosed of relapsed/refractory desmoplastic small round cell tumor (DSRCT) or Ewing sarcoma.
  3. DSRCT subjects must have received at least one previous poli-chemotherapy line.
  4. Ewing sarcoma subjects must have received at least two standard chemotherapy lines.
  5. Age ≥ 6 months and ≤ 40 years.
  6. Availability of archive tumor blocks or slides (new biopsy recommended).
  7. Measurable disease, according to RECIST 1.1 criteria.
  8. Performance status ≤1 (ECOG).
  9. Adequate respiratory functions: FEV1 > 1L.
  10. Normal ECG values.
  11. Adequate bone marrow function (hemoglobin ≥ 9 g/dL, leukocytes ≥ 3,000/mm3, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3). Subjects with plasma creatinine ≤ 1.6 mg/dL, transaminases ≤ 2.5 times the ULN, total bilirubin ≤ ULN, CPK ≤ 2.5 times ULN, alkaline phosphatase ≤ 2.5 times the ULN are acceptable. If alkaline phosphatase is > 2.5 times the ULN, then the alkaline phosphatase liver fraction and/or 5' nucleotidase and/or GGT must be ≤ ULN.
  12. Men or women of child bearing potential should be using an effective method of contraception before entry into the study and throughout the same and for 6 months after ending the study. Women of childbearing potential must have a negative urine pregnancy test before study entry.
  13. HBV and HCV serologies must be performed prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+) remaining at investigators' discretion the preventive treatment with lamivudine. If a potential subject is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the subject should NOT be included in the study (if a qualitative PCR cannot be performed then subject will not be able to enter the study).
  14. Prior taxane therapy for any indication is accepted.
  15. > Grade 3 (intense and diffuse) expression of SPARC by immunohistochemistry.

Exclusion criteria:

  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
  6. Hb < 9 g/dL.
  7. 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.
  8. Known hypersensitivity to protein bound paclitaxel.
  9. Any other concurrent condition that in the investigators opinion would jeopardize compliance with the protocol.
  10. Known positive test for infection by human immunodeficiency virus (HIV).
  11. Subjects participating in another clinical trial or receiving any other investigational product.
Sexes Eligible for Study: All
6 Months to 80 Years   (Child, Adult, Senior)
No
Contact: Patricio Ledesma +34 971439900 ensayos@sofpromed.com
Contact: Gabriela Golab +34 648414261 ggolab@sofpromed.com
Spain
 
 
NCT03275818
GEIS-39
2016-002464-14 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Grupo Espanol de Investigacion en Sarcomas
Grupo Espanol de Investigacion en Sarcomas
Not Provided
Study Director: Javier Martin Broto, MD Hospitales Universitarios Virgen del Rocío
Study Director: Jaume Mora, MD Hospital Sant Joan de Deu
Principal Investigator: Javier Martínez Trufero, MD Hospital Universitario Miguel Servet
Principal Investigator: Francisco Bautista, MD Hospital Universitario Niño Jesús
Principal Investigator: Antonio López Pousa, MD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Principal Investigator: Roberto Díaz, MD Hospital Universitario La Fe
Principal Investigator: José Antonio López-Martín, MD Hospital Universitario 12 de Octubre
Grupo Espanol de Investigacion en Sarcomas
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP