CT-322 in Treating Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma
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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 |
- Safety and tolerability of CT-322 [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
- 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) |
-
Drug: CT-322
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 | |
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 Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013