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A Phase II Study of Amrubicin in Relapsed or Refractory Thymic Malignancies

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.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : Amrubicin

Phase: Phase 2

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

3.1.1. Histologically or cytologically confirmed invasive or metastatic thymoma or thymic carcinoma. Locally invasive disease is acceptable, provided it is not resectable. 3.1.2. Previous treatment with at least one prior chemotherapy regimen. There is no limit on number of prior chemotherapy regimens. 3.1.3. Documented progressive disease after the most recent chemotherapy regimen. 3.1.4. Presence of measurable disease on imaging within 4 weeks prior to first dose, as defined per RECIST 1.1. See Section 9 regarding evaluation of measurable disease. 3.1.5. Completion of prior systemic therapy at least 4 weeks prior to first dose. 3.1.6. Prior treatment with immunotherapy is allowed, provided such therapy was completed at least 8 weeks prior to first dose. 3.1.7. Prior treatment with surgery is allowed, provided the surgery was completed at least 4 weeks prior to first dose and the patient is adequately recovered from surgery. 3.1.8. Prior radiation therapy is allowed, provided there are 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. 3.1.9. Age >= 18 years. 3.1.10. ECOG performance status of 0 or 1. 3.1.11. Adequate hematologic function as determined by the following tests within 4 weeks prior to first dose: 3.1.11.1. leukocytes >= 3000/mm3 3.1.11.2. absolute neutrophil count >= 1500/mm3 3.1.11.3. platelets >= 100,000/mm3 3.1.11.4. hemoglobin >= 9 g/d 3.1.12. Adequate hepatic function as determined by the following tests within 4 weeks prior to first dose: 3.1.12.1. serum bilirubin <1.5 x institutional upper limit of normal (ULN) 3.1.12.2. AST and ALT <3 x ULN 3.1.13. Adequate renal function as determined by the following tests within 4 weeks prior to first dose: 3.1.13.1. serum creatinine <1.5 times institutional upper limit of normal 3.1.13.2. if serum creatinine above institutional upper limit of normal, calculated serum creatinine clearance by the Cockcroft Gault method > 60 mL/min 3.1.14. Adequate cardiac function as determined by the following tests within 4 weeks prior to first dose: 3.1.14.1. left ventricular ejection fraction (LVEF) >= 50% by transthoracic echocardiogram (TTE) or multiple gated acquisition scan (MUGA) 3.1.15. For females of childbearing potential, negative serum pregnancy test within 4 weeks of first dose. 3.1.16. For males and females of childbearing potential, use of effective contraceptive methods during the study. 3.1.17. Ability to understand and willingness to sign a written informed consent document.

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Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
ccto-office@stanford.edu
650-498-7061
Not Recruiting

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