CT-322 in Treating Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by:
Adnexus, A Bristol-Myers Squibb R&D Company
ClinicalTrials.gov Identifier:
NCT00374179
First received: September 8, 2006
Last updated: February 23, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: CT-322
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

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 [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the pharmacokinetics of CT-322 in these patients; [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • to assess whether antibodies to this drug develop in these patients; and [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • to make a preliminary assessment of the biological activity of CT-322 to alter tumor growth. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2006
Study Completion Date: February 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: CT-322
    IV solution, weekly or bi-weekly
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00374179

Locations
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Texas
Institute for Drug Development
San Antonio, Texas, United States, 78245-3217
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Adnexus, A Bristol-Myers Squibb R&D Company
  More Information

No publications provided by Adnexus, A Bristol-Myers Squibb R&D Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Director, Adnexus, A Bristol-Myers Squibb R&D Company, Adnexus, A Bristol-Myers Squibb R&D Company
ClinicalTrials.gov Identifier: NCT00374179     History of Changes
Other Study ID Numbers: CT-322.001
Study First Received: September 8, 2006
Last Updated: February 23, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 29, 2014