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The study of safety of a new organic arsenic compound in the treatment of hematological malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darinaparsin | Drug | 300mg/m2 of Darinaparsin given daily for five consecutive days to be repeated every 28 days for up to six months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| toxicities | 6 months |
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Inclusion Criteria
Hodgkin's or non-Hodgkin's Lymphoma.
≥ 1 prior therapy and currently requiring therapy.
Evaluable disease (defined by disease-specific criteria listed in Appendix 1)
≥ 18 years of age.
ECOG performance score ≤ 2 (see Appendix 2).
Life-expectancy ≥ 2 months.
Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee with jurisdiction over the site.
No anti-cancer therapy exception of hydroxyurea ≤ 3 weeks before Baseline (Day 1, Cycle 1).
The following clinical laboratory values < 2 weeks before Baseline:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami | Florida | United States | ||||
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D019046 | Bone Marrow Neoplasms |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D016399 | Lymphoma, T-Cell |
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C515055 | darinaparsin |
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| Chicago |
| Illinois |
| United States |
| Bethesda | Maryland | United States |
| Fargo | North Dakota | United States |
| Sioux Falls | South Dakota | United States |
| Morgantown | West Virginia | United States |
| D001855 |
| Bone Marrow Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |