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The purpose of this study is to provide continued therapy with Denileukin diftitox (ONTAK) to patients who are currently on therapy and who have no other suitable treatment options, where therapy is requested by their physician.
The Access Program will be provided as long as appropriate according to the judgment of the provider. If Denileukin diftitox (ONTAK) becomes commercially available without restriction, then the access program will be discontinued.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denileukin diftitox (ONTAK) | Drug | Given at a dose of 9 or 18mcg/kg/day by intravenous infusion over 30 to 60 minutes for 5 consecutive days every 21 days for 8 cycles. |
|
Inclusion Criteria:
To receive denileukin diftitox (ONTAK) under this protocol, the patient's physician must request this therapy for the specific patient. Patients may continue treatment with denileukin diftitox if they:
Exclusion Criteria:
Patients are not eligible for the Access Program with denileukin diftitox if they:
• Are not currently on denileukin diftitox therapy
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| Name | Affiliation | Role |
|---|---|---|
| Gary Palmer, MD | Eisai Inc. | Study Director |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C078456 | denileukin diftitox |
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