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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Stanford University
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Heather Wakelee, Stanford University
ClinicalTrials.gov Identifier:
NCT01364727
First received: May 31, 2011
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Thymoma
Thymus Cancer
Thymic Carcinoma
Drug: Amrubicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase II Study of Amrubicin in Relapsed or Refractory Thymic Malignancies

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Overall response rate (ORR) = (CR+PR) in patients with thymic malignancies. ORR assessed radiographically by RECIST criteria. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • progression-free survival in patients with thymic malignancies treated with amrubicin [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • disease control rate (DCR = CR+PR+SD) in patients with thymic malignancies treated with amrubicin. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 39
Study Start Date: June 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amrubicin
Amrubicin 35mg/m2 IV days 1-3 every 3 weeks
Drug: Amrubicin
35 mg/m2; IV on days 1-3 each 3 week cycle
Other Name: Calsed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

3.2.1. Current use, or use within 4 weeks prior to first dose, of any other investigational agents.

3.2.2. Known history of allergic reactions attributed to compounds of similar chemical or biologic composition to amrubicin.

3.2.3. Active malignancy requiring treatment other than thymic malignancy.

3.2.4. 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.

3.2.5. 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.

3.2.6. 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.

3.2.7. 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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364727

Contacts
Contact: Melanie San Pedro-Salcedo (650) 724-1388 msanpedro@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Melanie San Pedro-Salcedo    650-724-1388    msanpedro@stanford.edu   
Contact: Cancer Clinical Trials Office    (650) 498-7061      
Principal Investigator: Heather A. Wakelee         
Sub-Investigator: Dr. A. Dimitrios Colevas         
Sub-Investigator: Joel Neal         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Matthew Burns       matburns@iupui.edu   
Principal Investigator: Patrick Loehrer, MD         
Sponsors and Collaborators
Stanford University
Celgene Corporation
Investigators
Principal Investigator: Heather A. Wakelee Stanford University
  More Information

No publications provided

Responsible Party: Heather Wakelee, Assistant Professor-Med, Stanford University
ClinicalTrials.gov Identifier: NCT01364727     History of Changes
Other Study ID Numbers: THOR0003, SU-01142011-7369
Study First Received: May 31, 2011
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Thymus Neoplasms
Carcinoma
Thymoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases
Amrubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014