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

NCT00374179 | Completed Phase 1

• 1 other identifier: CT-322.001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of CT-322

  Throughout the study

Secondary Outcomes (3)

• To evaluate the pharmacokinetics of CT-322 in these patients;

  Throughout the study

• to assess whether antibodies to this drug develop in these patients; and

  Throughout the study

• to make a preliminary assessment of the biological activity of CT-322 to alter tumor growth.

  Throughout the study

Interventions

CT-322 DRUG

IV solution, weekly or bi-weekly

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Adnexus, A Bristol-Myers Squibb R&D Company: lead

Study Sites (3)

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

Institute for Drug Development

San Antonio, Texas, 78245-3217, United States

Location

Related Publications (1)

• 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.

  PMID: 21224368 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

CT-322

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2006
• First Posted: September 11, 2006
• Study Start: August 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: February 1, 2009
• Last Updated: February 24, 2009

Record last verified: 2009-02

Locations

US (3)