CT-322 in Treating Patients With Recurrent Glioblastoma Multiforme and Combination Therapy With Irinotecan

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Adnexus, A Bristol-Myers Squibb R&D Company.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Adnexus, A Bristol-Myers Squibb R&D Company
ClinicalTrials.gov Identifier:
NCT00562419
First received: November 20, 2007
Last updated: October 26, 2010
Last verified: October 2010
  Purpose

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
Brain and Central Nervous System Tumors
Recurrent Glioblastoma Multiforme
Drug: CT-322
Drug: irinotecan hydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Adnexus, A Bristol-Myers Squibb R&D Company:

Primary Outcome Measures:
  • Safety and tolerability of CT-322 when administered alone or in combination with irinotecan hydrochloride (Part 1) [ Time Frame: 15 ± 5 days post the last dose of study drug ] [ Designated as safety issue: Yes ]
  • Progression-free survival at 6 months (Part 2) [ Time Frame: Measured upon initiation of cycles 2, 3, 5, 7, 9, 11, and end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • To assess the presence of anti CT-322 antibodies [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • To assess the biological activity of CT-322 as measured by plasma biological markers and neuroimaging [ Time Frame: 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: October 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CT-322
Drug: CT-322
IV solution, weekly
Experimental: 2
CT-322 and irinotecan hydrochloride
Drug: CT-322
IV solution, weekly
Drug: irinotecan hydrochloride
IV solution, biweekly

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS

  • Histologically confirmed diagnosis of recurrent/progressive GBM presenting in first, second, or third relapse (progression following anti-cancer therapy other than surgery)
  • Bidimensionally measurable recurrent or residual primary disease on contrast-enhanced MRI

PATIENT CHARACTERISTICS

Age:

• 18 and over

Hematopoietic:

  • ANC ≥ 1,500/mL
  • Platelets ≥ 100,000/mL
  • Hemoglobin ≥ 9.0g/dL

Hepatic:

  • AST and ALT ≤ 1.5 x ULN
  • Bilirubin ≤ 1.5 x ULN

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

  • 2-dimensional echocardiogram or cardiac multigated acquisition (MUGA) scan demonstrating left ventricular ejection fraction within the institutional normal range.
  • No coronary artery bypass graft, angioplasty, vascular stenting, myocardial infarction, unstable angina, congestive heart failure within the preceding 12 months.
  • No thrombotic or embolic cerebrovascular accident, including transient ischemic attacks within the past 12 months and no conditions that would not permit the safe discontinuation of specified anti-platelet medications
  • No intraparenchymal CNS hemorrhage, except for Grade 1 intraparenchymal hemorrhage in the immediate post-operative period or Grade 1 intraparenchymal hemorrhage that has been stable or improved

Immunologic:

• Not known to have human immunodeficiency virus infection (HIV) or active hepatitis B or C virus infection

Other:

  • Negative pregnancy test within 72 hours prior to drug administration
  • Not pregnant or breast feeding
  • Fertile patients must agree to use effective methods of birth control and must agree to do so until at least 4 weeks after the last dose of drug administration
  • No serious non-healing wound, ulcer or bone fracture or recent significant traumatic injury (within 4 weeks)
  • Have ability to understand and sign an informed consent document
  • Be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
  • No other malignancy within the past 3 years, except for basal cell skin cancer, cervical carcinoma in situ, or other primary malignancy that is not currently clinically significant or does not require active intervention
  • No prior grade 3 or greater toxicity to irinotecan
  • No other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that could increase the risks associated with study participation or study drug administration or could interfere with the interpretation of the study results and would make the patient inappropriate for study entry

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • At least 4 weeks between prior biological or immunotherapy and recovered

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy and recovered (6 weeks for nitrosoureas), unless there is unequivocal evidence of tumor progression

Radiotherapy:

• At least 12 weeks from completion of standard, daily radiotherapy and recovered, unless any of the following occurs:

  • New area of enhancement on MRI that is outside the radiotherapy field
  • Biopsy-proven recurrent tumor
  • Radiographic evidence of progressive tumor on 2 consecutive scans taken ≥ 4 weeks apart

Surgery

  • At least 4 weeks since major surgery, open biopsy or significant traumatic injury and recovered
  • At least 1 week since other prior biopsy

Other:

  • Not concurrently enrolled in another therapeutic clinical trial involving ongoing therapy
  • No prior treatment with VEGF or VEGFR inhibitors or vascular targeting/disrupting agents
  • No prior CT-322 therapy
  • No prior failure of irinotecan therapy
  • No prior treatment with stereotactic radiosurgery, brachytherapy, or a surgically created resection cavity to support other anatomically localized therapies
  • No severe or uncontrolled medical disease (uncontrolled diabetes, hypertension, serious infection > CTCAE grade 2, significant bleeding or platelet dysfunction, gastrointestinal bleed)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562419

Locations
United States, California
University of California, San Diego
La Jolla, California, United States, 92037-0845
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Virginia
University of Virgina
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
University of Wisconsin Hospital
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Adnexus, A Bristol-Myers Squibb R&D Company
  More Information

No publications provided

Responsible Party: Medical Director, Adnexus, A Bristol-Myers Squibb R&D Company, Adnexus, A Bristol-Myers Squibb R&D Company
ClinicalTrials.gov Identifier: NCT00562419     History of Changes
Other Study ID Numbers: CT-322.002
Study First Received: November 20, 2007
Last Updated: October 26, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Glioblastoma
Neoplasms by Site
Neoplasms
Nervous System Diseases
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Irinotecan
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014