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RATIONALE: CT-322 may stop the growth of glioblastoma multiforme by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving CT-322 together with irinotecan may kill more tumor cells.
PURPOSE: This phase 2 trial is studying the side effects, tolerability, and efficacy of CT-322 when given alone and in combination with irinotecan to patients with glioblastoma multiforme.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | CT-322 |
|
| 2 | Experimental | CT-322 and irinotecan hydrochloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-322 | Drug | IV solution, weekly |
| |
| irinotecan hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of CT-322 when administered alone or in combination with irinotecan hydrochloride (Part 1) | 15 ± 5 days post the last dose of study drug | |
| Progression-free survival at 6 months (Part 2) | Measured upon initiation of cycles 2, 3, 5, 7, 9, 11, and end of study |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the plasma pharmacokinetics of CT-322 (Cmax, Tmax, AUC, T-HALF) derived from plasma concentration vs time for CT-322 given alone and in combination with irinotecan | Part 1: cycle 1, days 1-3, day 5 or 6, days 8, 15, and 22; cycles 2-4, 6, 9, and 12, day 1; EOS and follow up visits. Part 2: cycle 1, days 1, 8, 15, and 22; cycles 2-4, 6, 9, and 12, day 1; EOS and follow up visits. | |
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DISEASE CHARACTERISTICS
PATIENT CHARACTERISTICS
Age:
• 18 and over
Hematopoietic:
Hepatic:
Coagulation:
• INR < 1.5 or PT within normal limits; and PTT within normal limits
Renal:
Creatinine ≤ 1.5 x ULN; Urine protein/creatinine ratio ≤ 1
Cardiovascular
Immunologic:
• Not known to have human immunodeficiency virus infection (HIV) or active hepatitis B or C virus infection
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Radiotherapy:
• At least 12 weeks from completion of standard, daily radiotherapy and recovered, unless any of the following occurs:
Surgery
Other:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92037-0845 | United States | ||
| University of Kentucky |
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| Drug |
IV solution, biweekly |
|
| To assess the presence of anti CT-322 antibodies |
| Part 1: cycle 1, days 1 and 15; cycles 2-4, 6, 9, and 12, day 1; EOS and follow up visits. Part 2: cycle 1, days 1 and 15; cycles 2-4, 6, 9, and 12, day 1; EOS and follow up visits. |
| To assess the biological activity of CT-322 as measured by plasma biological markers and neuroimaging | Part 1: cycle 1, days 1, 2, 8, 15 and 22; cycles 2-4, 6, 9, and 12, day 1; EOS visit. Part 2: cycle 1, days 1, 8, 15 and 22; cycles 2-4, 6, 9, and 12 EOS visit. |
| Lexington |
| Kentucky |
| 40536 |
| United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02114 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Virgina | Charlottesville | Virginia | 22908 | United States |
| University of Wisconsin Hospital | Madison | Wisconsin | 53792 | United States |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C549678 | CT-322 |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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