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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00374179
• Other study ID #: CT-322.001
• Status: Completed
• Phase: Phase 1
• First received: September 8, 2006
• Last updated: February 23, 2009
• Start date: August 2006
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: Adnexus, A Bristol-Myers Squibb R&D Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cancer
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• CT-322
IV solution, weekly or bi-weekly

Locations

Country	Name	City	State
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Institute for Drug Development	San Antonio	Texas
United States	South Texas Accelerated Research Therapeutics	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Adnexus, A Bristol-Myers Squibb R&D Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of CT-322		Throughout the study	Yes
Secondary	To evaluate the pharmacokinetics of CT-322 in these patients;		Throughout the study	No
Secondary	to assess whether antibodies to this drug develop in these patients; and		Throughout the study	No
Secondary	to make a preliminary assessment of the biological activity of CT-322 to alter tumor growth.		Throughout the study	No