A Phase 1 interventional study of 2'-F-ara-deoxyuridine and positron emission tomography in Adult Grade III Lymphomatoid Granulomatosis, Adult Nasal Type Extranodal NK/T-cell Lymphoma and Anaplastic Large Cell Lymphoma, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-07.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
Drugs used in chemotherapy, such as FAU, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. This phase I trial is studying the side effects and best dose of FAU in treating patients with advanced solid tumors or lymphoma.
PRIMARY OBJECTIVES:
I. To assess the safety and tolerability of FAU in patients with advanced solid tumors or lymphoma.
II. To determine the dose-limiting toxicity and maximum tolerated dose (MTD) of FAU in these patients.
SECONDARY OBJECTIVES:
I. To observe the clinical response in patients treated with FAU. II. To characterize the pharmacokinetics of FAU in these patients. III. To explore whether an association exists between pre-treatment 18F-FAU PET standardized uptake value levels and time to tumor progression after treatment with unlabeled FAU.
IV. To estimate the protein levels of thymidylate synthase (TS) in archival tumor tissue samples and to compare them with thymidine kinase (TK) and TS protein levels and TK and TS mRNA levels in fresh tumor tissue samples from patients treated at the MTD.
V. To explore the relationship between genetic polymorphisms of TS and tumor 18F-FAU uptake.
OUTLINE: This is a multicenter study.
Patients receive FAU IV over 1 hour on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed for 30 days.
392 studies on the registry are indexed under Burkitt Lymphoma; 114 are open to participants now.
This study's enrollment of 12 is below the median of 41 across 354 interventional studies indexed under Burkitt Lymphoma.
Browse Burkitt Lymphoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
No uncontrolled illness including, but not limited to, any of the following:
Patients will receive a 1-hour infusion of FAU on days 1-5.
Drug: 2'-F-ara-deoxyuridine · Other: positron emission tomography · Other: laboratory biomarker analysis · Other: pharmacological study · Other: pharmacogenomic studies
Given IV
Also known as: FAU
Correlative studies
Also known as: FDG-PET, PET, PET scan, tomography, emission computed
Correlative studies
Correlative studies
Also known as: pharmacological studies
Correlative studies
Also known as: Pharmacogenomic Study
Maximum tolerated dose, defined as the dose at which no more than 1/6 patients develops dose-limiting toxicity, graded by NCI CTCAE version 4.0
Time frame: Up to 28 days
Clinical response to FAU, evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee
Response will be described by point estimates and exact confidence intervals.
Time frame: Up to 30 days
Pharmacokinetics of FAU, including Cmax, Tmax, AUC 0-last, AUC 0-infinity, CL, t1/2, and Vss
All pharmacokinetic parameters will be summarized with standard descriptive statistics.
Time frame: Days 1 and 22 of course 1 at pre-treatment; at the end of infusion; and following the end of infusion at 15 and 30 minutes and 1, 2, 4, 8, and 24 hours
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)