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Study enrollment was withdrawn as it is no longer the sponsor's intention to study this indication under this protocol.
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This study is a Phase I trial of Darinaparsin in combination with CHOP for the treatment of lymphoma. Eligible patients will not have had any previous anti-cancer treatment and will be eligible to receive CHOP alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm, darinaparsin and CHOP | Experimental | open label, single arm, unblinded |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| darinaparsin | Drug | I.V. darinaparsin given in a dose escalation manner, once a day for 5 days per cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Define Toxicity profile | This is an open-label, dose-escalation Phase I study to define the toxicity profile and the maximum tolerated dose (MTD) of intravenously administered darinaparsin in combination with CHOP in patients with previously untreated lymphomas who are scheduled to receive CHOP alone (rituximab is not permitted) | One Year |
| Maximum Tolerated Dose | This is an open-label, dose-escalation Phase I study to define the toxicity profile and the maximum tolerated dose (MTD) of intravenously administered darinaparsin in combination with CHOP in patients with previously untreated lymphomas who are scheduled to receive CHOP alone (rituximab is not permitted). | One Year |
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Inclusion Criteria:
Patients with histological or cytological confirmation of lymphoma who are previously untreated and are scheduled to receive CHOP alone. Since the objective of the study is the assessment of safety, eligible subjects may have any type of lymphoma (Hodgkin's or non-Hodgkin's, T-cell or B-cell), as long as the scheduled therapy is CHOP alone.
Men and women of ≥18 years of age.
ECOG performance score ≤2
Life expectancy ≥12 weeks.
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements, to be conducted <2 weeks prior to first dose of study drug:
Adequate vascular access for repeated blood sampling.
Men and women of childbearing potential must agree to use effective contraception from Screening through 30 days after the last dose of study drug.
Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee (IEC/IRB) having jurisdiction over the site.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan J. Lewis, MD, PhD | ZIOPHARM, Oncology, Inc. | Study Director |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C515055 | darinaparsin |
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| CHOP | Drug | Cyclophosphamide 750 mg/m2 IV Day 8 of each Cycle; Doxorubicin 50 mg/m2 IV Day 8 of each Cycle; Vincristine 1.4 mg/m2 IV Day 8 of each Cycle; Prednisone 100 mg oral Days 8-12 of each Cycle. |
|
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |