Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 38 of 2167 for:    doxorubicin

Study to Assess TOPO2A as a Biomarker for Sensitivity to Doxorubicin/Doxil in Soft Tissue Sarcoma

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.
 
ClinicalTrials.gov Identifier: NCT04055753
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Fox Chase Cancer Center

Brief Summary:

The primary aim of this study is to determine the utility of TOPO2A as a biomarker for sensitivity to doxorubicin or its derivatives. Patients whose planned therapy is doxorucibin or doxil single agent may be enrolled into this trial. In light of its recent FDA approval and differing mechanism of action, patients receiving olaratumab along with doxorubicin will be eligible for this study.

Doxorucibin will be administered at standard 21-day intervals. Doxil will be administered at standard 28-day intervals. Response to therapy will be assessed using standard RECIST criteria every 2 cycles. Patients will continue on study until disease progression, prohibitive toxicity or completion of cumulative dose of 450 mg/m2 of either agent. Overall survival will be assessed every 3 months for 1 year, every 6 months in year 2 and, annually until death.


Condition or disease Intervention/treatment
Soft Tissue Sarcoma Drug: Doxil Drug: Doxorubicin

Layout table for study information
Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study to Assess Topoisomerase II Alpha (TOPO2A) as a Biomarker for Sensitivity to Doxorubicin/Doxil in Soft Tissue Sarcoma
Actual Study Start Date : August 12, 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021


Group/Cohort Intervention/treatment
Doxorubicin Drug: Doxorubicin
Doxorubicin 75 mg/m2, IV over 5-15 min OR Continuous infusion over 48-72 hours

Doxil Drug: Doxil
Doxil 50 mg/m2, as per institutional standard




Primary Outcome Measures :
  1. Best overall response [ Time Frame: 6 years ]
    best response recorded from the start of the treatment until disease progression/recurrence


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 6 years ]
    defined as the time from initiation of treatment until death from any cause


Biospecimen Retention:   Samples Without DNA
Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients whose planned therapy is doxorucibin or doxil single agent may be enrolled into this trial.
Criteria

Inclusion Criteria:

  • Patients must consent to providing tumor tissue prior to initiation of therapy if sufficient archival tissue is not available. Archival tissue is permitted if no other anticancer treatment was given after the tissue was obtained (not including surgery or radiation). If a biopsy is required, the treating physician should ensure that this can be done safely.
  • Patients with STS will be eligible for the trial if their next planned chemotherapy will include single agent doxorubicin or doxil. Patients who will be receiving concomitant therapy with olaratumab will be allowed to participate.
  • Sarcoma subtypes of angiosarcoma, epithelioid sarcoma, leiomyosarcoma, fibrosarcoma, myxofibrosarcoma, synovial sarcoma, pleomorphic rhabdomyosarcoma, undifferentiated pleomorphic sarcoma, liposarcoma (excluding well-differentiated) and malignant peripheral nerve sheath tumor will be included. These are subtypes for which a targeted therapy is not standard of care. All other subtypes will be included on a case by case basis as determined by the principle investigator.
  • ≥ 18 years of age.
  • Ability to understand and willingness to sign a written informed consent and HIPPA document
  • Measurable disease by RECIST 1.1 criteria (at least one target lesion outside of previous radiation fields or progressed within a previous radiation field).
  • Life expectancy of at least 3 months.
  • All women of childbearing potential must have a negative serum pregnancy test and all subjects must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose. Post-menopausal women must meet the criteria of 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >35 mIU/ml (IU/L).
  • Patients must have normal organ and marrow function as defined below

    • Absolute neutrophil count > 1,500/mcL
    • Platelets > 100,000/mcL
    • Total bilirubin ≤ 1.5 X upper limit of normal (ULN)
    • AST/ALT (SGOT/SGPT) ≤ 3 X institutional normal limits; if liver metastases are present then ≤ 5 X ULN are allowed

Exclusion Criteria:

  • Patients may not be receiving any other investigational agents, chemotherapy, radiation therapy or hormonal therapy (i.e. aromatase inhibitors for leiomyosarcoma), with the exception of olaratumab
  • Pregnant or breast feeding women.
  • Any concomitant medical issue that in the opinion of the treating physician would confound survival from sarcoma (e.g. other active cancer, symptomatic brain metastases, cardiac conditions).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055753


Contacts
Layout table for location contacts
Contact: Margaret von Mehren, MD 215-728-2460 margaret.vonmehren@fccc.edu

Locations
Layout table for location information
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Margaret von Mehren, MD    215-728-2460    Margaret.vonMehren@fccc.edu   
Sponsors and Collaborators
Fox Chase Cancer Center

Layout table for additonal information
Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT04055753     History of Changes
Other Study ID Numbers: SAR-082
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Doxorubicin
Liposomal doxorubicin
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action