Sarcoma, Soft Tissue
Conditions
Brief summary
The purpose of this study is to determine the clinical response rate (complete response and partial response) in patients with metastatic, locally advanced, or locally recurrent vascular soft tissue sarcoma treated with sunitinib.
Detailed description
Soft tissue sarcomas are rare tumors that arise from mesenchymal tissue from anywhere in the body. While surgical intervention can offer a cure for localized soft tissue sarcoma, treatment of unresectable and metastatic disease is particularly challenging. New treatment options are needed for patients with unresectable or metastatic disease if they progress or cannot tolerate conventional chemotherapy. This study will investigate sunitinib - a novel orally-administered multitargeted tyrosine kinase inhibitor with anti-tumor and antiangiogenic activities.
Interventions
DRUGSunitinib
Taken daily PO for a 42 day cycle. This cycle is repeated at least twice. A small molecule, multi-targeted receptor tyrosine kinase inhibitor that selectively targets and intracellularly blocks the signaling pathways of receptor tyrosine kinase (RTKs).
Sponsors
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histopathologically-proven diagnosis of angiosarcoma, epithelioid sarcoma-like hemangioendothelioma or Kaposi's sarcoma. Both HIV-Related and HIV-Unrelated Kaposi's patients will be included in the trial. Patients with HIV-Related Kaposi's will be required to have a CD4 count \>50 cells/µL and Viral Load \< 50 copies/ml. They will also need to be willing to take HAART. They can either have stable Kaposi's on HAART for at least 3 months or have progression of their Kaposi's after having been on HAART for at least 10 weeks. * Not amenable to surgery, radiation, or combined modality treatment with curative intent. * Evidence of unidimensionally measurable disease by conventional radiographic techniques. In patients with Kaposi's sarcoma, skin lesions at least 10 mm will be considered measurable disease. Bone lesions, ascites, or lymphangitis of skin or lung are not considered measurable. * No more than 2 prior chemotherapy regimens for metastatic or unresectable disease. Patients may have received prior bevacizumab or other Tyrosine Kinase Inhibitors, excluding sunitinib. Treatment with bevacizumab or other Tyrosine Kinase Inhibitors will not be counted as prior chemotherapy regimens. * Four weeks since prior chemotherapy, surgery or radiation therapy and resolution of all toxic effects of any prior therapy, surgical procedure or radiation. * ECOG performance status 0-2. * Age 18 or greater.
Exclusion criteria
* Patients with a currently active second malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix are not to be registered. Patients who are not considered to have a currently active malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse. * No areas of measurable disease by CT or MRI. * Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, or cerebrovascular accident. or transient ischemic attack, or pulmonary embolism. * Ongoing cardiac dysrhythmias, atrial fibrillation or prolongation of the QTc interval to \>450 msec for males of \> 470 msec for females. Medications that may prolong the QT intervals should be discontinued or switched to another medication prior to starting Sutent unless determined by the investigator to be absolutely necessary. * Pregnancy or breastfeeding. * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with the study participation or study drug administration. * Major surgery or radiation therapy within 4 weeks of starting the study treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Stable Disease at First Assessment of Response | Up to 84 days | CT or MRI to monitor response: CT or MRI to assess tumor measurement based on the RECIST criteria |
Countries
United States
Participant flow
Pre-assignment details
1 subject decided to pursue treatment elsewhere prior to receiving study drug after consent.
Participants by arm
| Arm | Count |
|---|---|
| Sunitinib Patients with unresectable or metastatic angiosarcoma, epithelioid sarcoma-like hemangioendothelioma and Kaposi's sarcoma, either receiving Sunitinib as first-line therapy or failure after no more than 2 prior chemotherapy regimens.
Sunitinib: Taken daily PO for a 42 day cycle. This cycle is repeated at least twice.
A small molecule, multi-targeted receptor tyrosine kinase inhibitor that selectively targets and intracellularly blocks the signaling pathways of receptor tyrosine kinase (RTKs). | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Non-compliance | 3 |
| Overall Study | Progressive disease | 2 |
Baseline characteristics
| Characteristic | Sunitinib |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 9 |
| serious Total, serious adverse events | 1 / 9 |
Outcome results
Primary
Number of Subjects With Stable Disease at First Assessment of Response
CT or MRI to monitor response: CT or MRI to assess tumor measurement based on the RECIST criteria
Time frame: Up to 84 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib | Number of Subjects With Stable Disease at First Assessment of Response | 6 participants |