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This an an open-label study to define the safety profile and the maximum tolerated dose and confirm the clinical effective dose of palifosfamide-tris given intravenously in combination with etoposide and carboplatin in a wide range of cancers which etoposide and carboplatin are normally given. Once the maximum dose of palifosfamide-tris is determined,a Phase II study using the 3 agents combined will begin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PaCE | Experimental | Palifosfamide, Carboplatin and Etoposide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| palifosfamide-tris | Drug | Intravenous on days 1, 2 and 3 of each 21-day cycle for up to 4 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety profile | Adverse events, vital signs, physical examination, laboratory data and concomitant medications | 21 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the maximum tolerated dose | Each dose level cohort will be 3 subjects. After 3 subjects have received a regimen, there will be a minimum observation period of 1 full cycle (21 days) for each of the 3 subjects before enrollment of the group of subjects at the next dose level. | Up to 21 days |
| Assess early signs of efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Simon Cancer Center | Indianapolis | Indiana | 46202 | United States | ||
| Horizon Oncology Research |
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To assess early signs of efficacy using this investigational combination in this patient population |
| duration of study |
| Lafayette |
| Indiana |
| 47905 |
| United States |
| Medical Consultants, PC | Muncie | Indiana | 47303 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| D013736 | Testicular Neoplasms |
| D013945 | Thymoma |
| D010051 | Ovarian Neoplasms |
| D012516 | Osteosarcoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D013953 | Thymus Neoplasms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D005833 | Genital Neoplasms, Female |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D012509 | Sarcoma |
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| ID | Term |
|---|---|
| C027061 | isophosphamide mustard |
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