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Sponsored by: |
Adnexus, A Bristol-Myers Squibb R&D Company |
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Information provided by: | Adnexus, A Bristol-Myers Squibb R&D Company |
ClinicalTrials.gov Identifier: | NCT00562419 |
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.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors Recurrent Glioblastoma Multiforme |
Drug: CT-322 Drug: irinotecan hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Phase 2, 2-Part, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of CT-322 Monotherapy and Combination Therapy With Irinotecan in Patients With Recurrent Glioblastoma Multiforme |
Estimated Enrollment: | 72 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
CT-322
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Drug: CT-322
IV solution, weekly
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2: Experimental
CT-322 and irinotecan hydrochloride
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Drug: CT-322
IV solution, weekly
Drug: irinotecan hydrochloride
IV solution, biweekly
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS
PATIENT CHARACTERISTICS
Age:
Hematopoietic:
Hepatic:
Coagulation:
Renal:
Creatinine ≤ 1.5 x ULN; Urine protein/creatinine ratio ≤ 1
Cardiovascular
Immunologic:
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:
Contact: Richard Barnette | 910-558-6929 | richard.barnette@wilm.ppi.com |
Contact: Lisamarie Burgio | 716-835-4633 | lisamarie.burgio@wilm.ppi.com |
United States, Kentucky | |
University of Kentucky | Not yet recruiting |
Lexington, Kentucky, United States, 40536 | |
United States, Massachusetts | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02114 | |
United States, Michigan | |
Henry Ford Health System | Recruiting |
Detroit, Michigan, United States, 48202 | |
United States, New York | |
SUNY Upstate Medical University | Not yet recruiting |
Syracuse, New York, United States, 13210 | |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
United States, Rhode Island | |
Rhode Island Hospital | Recruiting |
Providence, Rhode Island, United States, 02903 | |
United States, Texas | |
South Texan Oncology and Hematology | Recruiting |
San Antonio, Texas, United States, 78258 | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
University of Virgina | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
United States, Wisconsin | |
University of Wisconsin Hospital | Recruiting |
Madison, Wisconsin, United States, 53792 |
Responsible Party: | Adnexus, A Bristol-Myers Squibb R&D Company ( Medical Director, Adnexus, A Bristol-Myers Squibb R&D Company ) |
Study ID Numbers: | CT-322.002 |
Study First Received: | November 20, 2007 |
Last Updated: | August 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00562419 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Glioblastoma Astrocytoma Irinotecan Central Nervous System Neoplasms Recurrence Camptothecin Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Glioblastoma Multiforme Antineoplastic Agents, Phytogenic Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Glioblastoma Disease Attributes Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Irinotecan Central Nervous System Neoplasms Neoplasms by Site Pathologic Processes Neoplasms, Germ Cell and Embryonal Therapeutic Uses Glioma Nervous System Neoplasms |
Neoplasms by Histologic Type Astrocytoma Nervous System Diseases Enzyme Inhibitors Recurrence Camptothecin Pharmacologic Actions Neuroectodermal Tumors Neoplasms Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |