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| ID | Type | Description | Link |
|---|---|---|---|
| EProst # 20091095 | Other Identifier | Sylvester Comprehensive Cancer Center |
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Poor recruitment
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| Name | Class |
|---|---|
| University of Miami | OTHER |
| Miami VA Healthcare System | FED |
| University of Miami Sylvester Comprehensive Cancer Center | OTHER |
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The purpose of this study is to determine the appropriate dose of AEZS-108 to treat patients with a tumor of the urinary system.
AEZS-108 is an investigational drug, combining luteinizing hormone-releasing hormone (LHRH), an hormone and doxorubicin (a drug approved to treat different types of cancer).
Some tumors, such as those found in the urinary system (also called urothelial carcinomas), have LHRH hormone receptors to which the LHRH hormone part of AEZS-108 is attracted.
AEZS-108 is expected to work by accumulating mostly on the surface of cancer cells that have LHRH hormone receptors and by delivering doxorubicin more directly into the cells to kill them. This would allow the use doxorubicin at lower doses and thus would cause less toxicity.
In the first part of the study, the appropriate dose of AEZS-108 will be determined based on its side effects. The best dose will be the highest one without severe side effects.
In the second part of the study, this best dose of AEZS-108 will be given to determine its efficacy to stop the tumor from progressing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 - Cohort 1 | Experimental | Determination of maximum tolerated dose (MTD) and recommended parenteral administration dosing for AEZS-108 in 4 sequential cohorts of patients (3-6 patients/cohort). Patients will be enrolled in cohorts of 3 at a specified AEZS-108 dose beginning with 160mg/m^2. Enrollment will be suspended until all members of a cohort have been observed for dose limiting toxicities (DLT) for a period of 3 weeks (1 cycle of AEZS-108) from initial treatment with AEZS-108. Dose escalation will proceed within each cohort according to a specific scheme where DLT is defined. |
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| Phase 1 - Cohort 2 | Experimental | Determination of maximum tolerated dose (MTD) and recommended parenteral administration dosing for AEZS-108 in 4 sequential cohorts of patients (3-6 patients/cohort). |
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| Phase 1 - Cohort 3 | Experimental | Determination of maximum tolerated dose (MTD) and recommended parenteral administration dosing for AEZS-108 in 4 sequential cohorts of patients (3-6 patients/cohort). |
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| Phase 1 - Cohort 4 | Experimental | Determination of maximum tolerated dose (MTD) and recommended parenteral administration dosing for AEZS-108 in 4 sequential cohorts of patients (3-6 patients/cohort). |
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| Phase 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AEZS-108 | Drug | 128, 160, 210 or 267 mg/m2, 2-hour intravenous (IV) infusion, Day 1 of 21-day cycles , until toxicity or progression, up to 6 cycles |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) | Toxicity per Common Terminology Criteria for Adverse Events (CTCAE). | Day 1 of each 21-day cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Objective tumor response | Response evaluation criteria in solid tumors (RECIST) criteria. | Within 5 days of cycle 4, then every 3 cycles |
| Progression-free survival (PFS) | Time elapsed from the start of treatment to the date of documented progression or death, whichever comes first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gustavo Fernandez, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States | ||
| Univerity of Pennsylvania |
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| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| D014516 | Ureteral Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C080883 | LHRH, lysine(6)-doxorubicin |
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Phase 1 : conventional 3+3 design. Phase 2: Simon's two-stage design will be utilized. In Stage I, 22 patients will be treated with the dose determined in Phase I. The study will be terminated for futility if no more than 2 patients out of the 22 patients in Stage I are responders. If 3 or more responders are observed, an additional 18 patients will be enrolled. If at least 8 out of the 40 patients are responders, the treatment will be considered worthy of further development.
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| Experimental |
AEZS-108 at MTD to determine efficacy in up to 40 patients. |
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| AEZS-108 at MTD | Drug | 2-hour IV infusion, Day 1 of 21-day cycles , until toxicity or progression, up to 6 cycles |
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| last cycle |
| Pharmacokinetics (PK) | To evaluate PK parameters of a single dose AEZS-108 and explore whether the PK parameters are associated with cardiac effects as measured by electrocardiography. | cycle 1 |
| Overall survival | Time elapsed from the start of treatment until death. | last cycle |
| Circulating tumor cell (CTC) levels | To quantify tumor cells and attempt to correlate their presence and response to the outcomes of this study. | last cycle |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| D014571 |
| Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |