A Phase 2 Study of Amrubicin in Relapsed or Refractory Thymic Malignancies
Condition: Thymoma; Thymus Cancer; Thymic Carcinoma
MeSH terms: Thymoma; Thymus Neoplasms
Intervention: Amrubicin
Intervention description: 35 mg/m2; IV on days 1-3 each 3 week cycle
Intervention MeSH terms: Amrubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A research study of the drug amrubicin in patients with cancer of the thymus (thymoma or
      thymic carcinoma). We hope to learn whether this drug is an effective and safe treatment for
      thymic cancers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed invasive or metastatic thymoma or thymic
             carcinoma. Locally invasive disease is acceptable, provided it is not resectable.

          -  Previous treatment with at least one prior chemotherapy regimen.

          -  Documented progressive disease after the most recent chemotherapy regimen.

          -  Presence of measurable disease on imaging within 4 weeks prior to first dose

          -  Completion of prior systemic therapy at least 4 weeks prior to first dose.

          -  Any prior immunotherapy therapy completed at least 8 weeks prior to first dose.

          -  Any prior surgery completed at least 4 weeks prior to first dose, with adequate
             recovered from surgery.

          -  Any prior radiation therapy must have no residual toxic effects of therapy. Chest
             radiotherapy with curative intent to the primary disease complex must have been
             completed ≥ 28 days prior to first dose. Cranial radiation must have been completed ≥
             21 days prior to first dose. Radiotherapy to all other areas must have been completed
             ≥ 7 days prior to first dose.

          -  Age ≥ 18 years.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          -  Leukocytes ≥ 3000/mm³

          -  Absolute neutrophil count ≥ 1500/mm³

          -  Platelets ≥ 100,000/mm³

          -  Hemoglobin ≥ 9 g/d

          -  Serum bilirubin < 1.5 x institutional upper limit of normal (ULN)

          -  Aspartate transaminase (AST) and alanine transaminase (ALT) ratio < 3 x ULN

          -  Serum creatinine < 1.5 times institutional upper limit of normal if serum creatinine
             above institutional upper limit of normal, calculated serum creatinine clearance by
             the Cockcroft Gault method > 60 mL/min

          -  Left ventricular ejection fraction (LVEF) ≥ 50% by transthoracic echocardiogram (TTE)
             or multiple gated acquisition scan (MUGA)

          -  For females of childbearing potential, negative serum pregnancy test within 4 weeks of
             first dose.

          -  For males and females of childbearing potential, use of effective contraceptive
             methods during the study.

          -  Ability to understand and willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Current use, or use within 4 weeks prior to first dose, of any other investigational
             agents.

          -  Known history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to amrubicin.

          -  Active malignancy requiring treatment other than thymic malignancy.

          -  Pregnant or nursing females due to unknown toxic effects of amrubicin on the
             developing fetus or in breast milk. Should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician
             immediately.

          -  Symptomatic central nervous system metastatic disease. Patients with asymptomatic
             brain metastases allowed. If treated with surgical resection or radiation therapy, the
             patient must be stable for >= 2 weeks after completion of therapy. If the patient is
             on corticosteroids, the dose of corticosteroids, the dose of corticosteroids must have
             been stable for >= 2 weeks prior to first dose of study treatment, or be in the
             process of being tapered.

          -  Concurrent severe or uncontrolled medical disease (including but not limited to active
             systemic infection, diabetes, hypertension, coronary artery disease, congestive hear
             failure and mental illness) that in the opinion of the investigator would compromise
             the safety of the patient or compromise the ability of the patient to complete the
             study.

          -  Known history of seropositive human immunodeficiency virus (HIV) or use of
             immunosuppressive medications for other conditions that would, in the opinion of the
             investigator, increase the risk of serious neutropenic complications.