AMG-479 in Treating Patients With Advanced Solid Tumors or Non-Hodgkin Lymphoma
Completed · Phase 1
Conditions studied: Lymphoma, Prostate Cancer, Sarcoma, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific
In brief
RATIONALE: Monoclonal antibodies, such as AMG-479, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. PURPOSE: This phase I trial is studying the side effects and best dose of AMG-479 in treating patients with advanced solid tumors or non-Hodgkin lymphoma.
Key facts
- Study ID
- NCT00562380
- Run by
- Amgen
- People needed
- 64
- Starts
- 2005-10-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2013-07-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed advanced solid tumors or non-Hodgkin lymphoma that is refractory to standard treatment or for which no curative therapy is available
- Tumor tissue that is accessible for biopsy by using minimally invasive procedures and must consent to undergo biopsies of the tumor (part 2)
- Exception for patients with Ewing family tumors or desmoplastic small round cell tumors whose anatomic location would pose an increase in the risk of injury due to biopsy (i.e., bleeding or pneumothorax)
- Willing to provide existing and/or future paraffin-embedded tumor samples
You may not qualify if…
- Primary CNS tumors or hematological malignancies, other than non-Hodgkin lymphoma
- Primary hepatic tumors or at increased risk for hepatic tumors, including any of the following:
- Hepatitis of any etiology
- Alcohol abuse or dependency
- Hepatic adenoma
- Follicular nodular hyperplasia
- Autoimmune conditions associated with biliary tract cancer
- Alpha 1 antitrypsin deficiency
- Hemochromatosis
- History of vinyl chloride or thorotrast/thorium dioxide exposure
- History of histiocytic (Kupffer cell) neoplasia
- Presence of untreated or symptomatic CNS metastases or symptoms of brain metastases
- Presence of ascites or pleural effusion requiring medical intervention
- PATIENT CHARACTERISTICS:
- Inclusion criteria:
- ECOG performance status ≤ 2
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Able to provide fasting blood samples for triglyceride and glucose laboratory tests
- Able to fast for 4-6 hours for fludeoxyglucose F18-PET/CT scan
- Controlled type 1 or 2 diabetes (defined as hemoglobin A1c < 8.0% and fasting blood glucose level < 160 mg/dL) allowed for part 2 only
- Exclusion criteria:
- History of clinically significant hypoglycemia or hyperglycemia (in the opinion of the investigator)
- Myocardial infarction within the past year
- Unstable or uncontrolled disease/condition related to or impacting cardiac function, including any of the following:
Where it is running
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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