Can a protein predict chemo success in sarcoma?
NCT ID NCT04055753
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether a protein called TOPO2A can help predict if the chemotherapy drugs doxorubicin or Doxil will shrink tumors in people with soft tissue sarcoma. About 24 patients whose next treatment plan includes one of these drugs will provide tumor tissue for testing. Researchers will track how well the tumor responds and how long patients live, to see if TOPO2A levels match up with treatment success.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Doxorubicin or Doxil (chemotherapy drugs)
- What this could lead to
- If successful, this could help doctors choose which patients are most likely to benefit from these chemotherapy drugs, personalizing treatment.
- What could go wrong
- This is a very small, early-phase study (24 people) focused on a biomarker, not a treatment itself. The biomarker may not reliably predict response, and results may not apply to all sarcoma types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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24 people
The number who actually took part.
- Started
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Aug 2016
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients whose planned therapy is doxorucibin or doxil single agent may be enrolled into this trial.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a Marine-Derived drug slow advanced soft tissue sarcoma?
- Can a One-Two punch of immunotherapy and radiation tame sarcoma before surgery?
- Can a radioactive antibody light up hidden tumors?
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- Could a massive tissue bank unlock sarcoma's secrets?