CT-322 in Treating Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma
Primary Purpose
Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CT-322
Sponsored by
About this trial
This is an interventional treatment trial for Cancer
Eligibility Criteria
DISEASE CHARACTERISTICS
- Histologically proven advanced solid malignancy or NHL for which no standard therapy exists or for which standard therapy had failed
- No known brain or leptomeningeal disease
- No prior bone marrow transplant or stem cell rescue
- No histologically confirmed squamous non-small cell lung cancer (NSCLC) with central chest tumor(s) still in place
PATIENT CHARACTERISTICS
Age:
* 18 and over
Performance status:
* ECOG performance status ≤ 2
Life expectancy:
* > 3 months
Hematopoietic:
- ANC ≥ 1500/mL
- Platelets ≥ 100,000/mL
- Hemoglobin ≥ 9.0 g/dL; and not requiring transfusion > 1 unit/month
Hepatic:
- AST and ALT ≤ 2.5 x ULN; if liver function abnormalities are due to the underlying malignancy, then AST and ALT may be ≤ 5 x the ULN
- Bilirubin ≤ 1.5 x ULN
- aPTT and PT < 1.5 x ULN
Renal:
- Creatinine ≤ 1.5 x ULN; patients with serum creatinine > 1 x ULN must also have creatinine clearance (based on a 24-hour urine collection) ≤ 60 mL/min
- No proteinuria > 1+ on dipstick analysis; in the case of > 1+ dipstick proteinuria, a 24-hour urine collection for protein must be < 500 mg/24 hours
- Urinary protein/creatinine ratio < 1
- No glomerulonephritis
Cardiovascular:
- No coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable angina, symptomatic congestive heart failure, severe uncontrolled hypertension, hemorrhagic or thrombotic stroke or any other CNS bleeding within the preceding 12 months
- LVEF normal by echocardiogram or MUGA within the past 12 months if there was prior exposure to anthracyclines or radiotherapy encompassing the heart
Immunologic:
* Not known to have human immunodeficiency virus (HIV), active hepatitis virus C (HVC), or active hepatitis virus B (HVB)
Other:
- Negative pregnancy test within 7 days prior to enrollment
- Not pregnant or breast feeding
- Fertile patients must agree to use effective contraception or commit to abstinence during the study period, or be surgically sterile
- No serious nonhealing wound, ulcer, or bone fracture
- Have the 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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- At least 4 weeks since prior biological or immunotherapy and recovered
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy and recovered
- At least 6 weeks for mitomycin C and nitrosoureas prior to study entry and recovered
Radiotherapy:
* At least 4 weeks since prior radiotherapy to a visceral organ and recovered
Surgery:
- At least 4 weeks since prior major or laparoscopic surgery and recovered
- At least 1 week since prior minor surgery
Other:
- No other concurrent anticancer therapy
- Not concurrently enrolled in another therapeutic clinical trial involving ongoing therapy
- No concurrent full dose, therapeutic anti-coagulation with warfarin or related oral anti-coagulants or unfractionated or low molecular weight heparins; low dose warfarin for catheter prophylaxis or acetylsalicylic acid ≤ 325 mg/day is acceptable
Sites / Locations
- Indiana University Cancer Center
- South Texas Accelerated Research Therapeutics
- Institute for Drug Development
Outcomes
Primary Outcome Measures
Safety and tolerability of CT-322
Secondary Outcome Measures
To evaluate the pharmacokinetics of CT-322 in these patients;
to assess whether antibodies to this drug develop in these patients; and
to make a preliminary assessment of the biological activity of CT-322 to alter tumor growth.
Full Information
NCT ID
NCT00374179
First Posted
September 8, 2006
Last Updated
February 23, 2009
Sponsor
Adnexus, A Bristol-Myers Squibb R&D Company
1. Study Identification
Unique Protocol Identification Number
NCT00374179
Brief Title
CT-322 in Treating Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma
Official Title
A Phase 1, Escalating Dose Study of CT-322, a VEGFR-2 Antagonist, as Monotherapy in Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Adnexus, A Bristol-Myers Squibb R&D Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
RATIONALE: CT-322 may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the cancer.
PURPOSE: This phase I trial is studying the side effects of CT-322 in treating patients with advanced solid tumors or non-Hodgkin's lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CT-322
Intervention Description
IV solution, weekly or bi-weekly
Primary Outcome Measure Information:
Title
Safety and tolerability of CT-322
Time Frame
Throughout the study
Secondary Outcome Measure Information:
Title
To evaluate the pharmacokinetics of CT-322 in these patients;
Time Frame
Throughout the study
Title
to assess whether antibodies to this drug develop in these patients; and
Time Frame
Throughout the study
Title
to make a preliminary assessment of the biological activity of CT-322 to alter tumor growth.
Time Frame
Throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS
Histologically proven advanced solid malignancy or NHL for which no standard therapy exists or for which standard therapy had failed
No known brain or leptomeningeal disease
No prior bone marrow transplant or stem cell rescue
No histologically confirmed squamous non-small cell lung cancer (NSCLC) with central chest tumor(s) still in place
PATIENT CHARACTERISTICS
Age:
* 18 and over
Performance status:
* ECOG performance status ≤ 2
Life expectancy:
* > 3 months
Hematopoietic:
ANC ≥ 1500/mL
Platelets ≥ 100,000/mL
Hemoglobin ≥ 9.0 g/dL; and not requiring transfusion > 1 unit/month
Hepatic:
AST and ALT ≤ 2.5 x ULN; if liver function abnormalities are due to the underlying malignancy, then AST and ALT may be ≤ 5 x the ULN
Bilirubin ≤ 1.5 x ULN
aPTT and PT < 1.5 x ULN
Renal:
Creatinine ≤ 1.5 x ULN; patients with serum creatinine > 1 x ULN must also have creatinine clearance (based on a 24-hour urine collection) ≤ 60 mL/min
No proteinuria > 1+ on dipstick analysis; in the case of > 1+ dipstick proteinuria, a 24-hour urine collection for protein must be < 500 mg/24 hours
Urinary protein/creatinine ratio < 1
No glomerulonephritis
Cardiovascular:
No coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable angina, symptomatic congestive heart failure, severe uncontrolled hypertension, hemorrhagic or thrombotic stroke or any other CNS bleeding within the preceding 12 months
LVEF normal by echocardiogram or MUGA within the past 12 months if there was prior exposure to anthracyclines or radiotherapy encompassing the heart
Immunologic:
* Not known to have human immunodeficiency virus (HIV), active hepatitis virus C (HVC), or active hepatitis virus B (HVB)
Other:
Negative pregnancy test within 7 days prior to enrollment
Not pregnant or breast feeding
Fertile patients must agree to use effective contraception or commit to abstinence during the study period, or be surgically sterile
No serious nonhealing wound, ulcer, or bone fracture
Have the 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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
See Disease Characteristics
At least 4 weeks since prior biological or immunotherapy and recovered
Chemotherapy:
See Disease Characteristics
At least 4 weeks since prior chemotherapy and recovered
At least 6 weeks for mitomycin C and nitrosoureas prior to study entry and recovered
Radiotherapy:
* At least 4 weeks since prior radiotherapy to a visceral organ and recovered
Surgery:
At least 4 weeks since prior major or laparoscopic surgery and recovered
At least 1 week since prior minor surgery
Other:
No other concurrent anticancer therapy
Not concurrently enrolled in another therapeutic clinical trial involving ongoing therapy
No concurrent full dose, therapeutic anti-coagulation with warfarin or related oral anti-coagulants or unfractionated or low molecular weight heparins; low dose warfarin for catheter prophylaxis or acetylsalicylic acid ≤ 325 mg/day is acceptable
Facility Information:
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
South Texas Accelerated Research Therapeutics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Institute for Drug Development
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78245-3217
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21224368
Citation
Tolcher AW, Sweeney CJ, Papadopoulos K, Patnaik A, Chiorean EG, Mita AC, Sankhala K, Furfine E, Gokemeijer J, Iacono L, Eaton C, Silver BA, Mita M. Phase I and pharmacokinetic study of CT-322 (BMS-844203), a targeted Adnectin inhibitor of VEGFR-2 based on a domain of human fibronectin. Clin Cancer Res. 2011 Jan 15;17(2):363-71. doi: 10.1158/1078-0432.CCR-10-1411. Epub 2011 Jan 11.
Results Reference
derived
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CT-322 in Treating Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma
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