Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00562419
Recruitment Status : Unknown
Verified October 2010 by Adnexus, A Bristol-Myers Squibb R&D Company.
Recruitment status was:  Active, not recruiting
First Posted : November 22, 2007
Last Update Posted : October 27, 2010
Sponsor:
Information provided by:
Adnexus, A Bristol-Myers Squibb R&D Company

Tracking Information
First Submitted Date  ICMJE November 20, 2007
First Posted Date  ICMJE November 22, 2007
Last Update Posted Date October 27, 2010
Study Start Date  ICMJE October 2007
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2010)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2007)
  • Safety and tolerability of CT-322 when administered alone or in combination with irinotecan hydrochloride (Part 1)
  • Progression-free survival at 6 months (Part 2)
Change History Complete list of historical versions of study NCT00562419 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2010)
  • 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. ]
  • 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. ]
  • 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. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2007)
  • Evaluate progression-free survival at 12 months and duration, overall survival and objective response rate
  • Pharmacokinetics
  • To assess the immunogenicity of CT-322
  • To assess the biological activity of CT-322 as measured by plasma biological markers and neuroimaging
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CT-322 in Treating Patients With Recurrent Glioblastoma Multiforme and Combination Therapy With Irinotecan
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain and Central Nervous System Tumors
  • Recurrent Glioblastoma Multiforme
Intervention  ICMJE
  • Drug: CT-322
    IV solution, weekly
  • Drug: irinotecan hydrochloride
    IV solution, biweekly
Study Arms  ICMJE
  • Experimental: 1
    CT-322
    Intervention: Drug: CT-322
  • Experimental: 2
    CT-322 and irinotecan hydrochloride
    Interventions:
    • Drug: CT-322
    • Drug: irinotecan hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 23, 2009)
72
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2007)
50
Estimated Study Completion Date  ICMJE December 2011
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00562419
Other Study ID Numbers  ICMJE CT-322.002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Director, Adnexus, A Bristol-Myers Squibb R&D Company, Adnexus, A Bristol-Myers Squibb R&D Company
Study Sponsor  ICMJE Adnexus, A Bristol-Myers Squibb R&D Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Adnexus, A Bristol-Myers Squibb R&D Company
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP