Clinical trial · Interventional
FAU in Treating Patients With Advanced Solid Tumors or Lymphoma
A Phase I Study of Intravenously Administered FAU (1-(2'-Deoxy-2'-Fluoro-B-D-arabinofuranosyl) Uracil, NSC#678515) in Patients With Advanced Solid Tumors
NCT00769288CI-TRIAL-00013346completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (60)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Grade III Lymphomatoid Granulomatosis | Adult Grade III Lymphomatoid Granulomatosis | ONTOLOGY_EXACT | 0.98 |
| Adult Nasal Type Extranodal NK/T-cell Lymphoma | Adult Nasal Type Extranodal NK/T-Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Anaplastic Large Cell Lymphoma | Anaplastic Large Cell Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Angioimmunoblastic T-cell Lymphoma | Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type | ALIAS | 0.90 |
| Cutaneous B-cell Non-Hodgkin Lymphoma | Primary Cutaneous B-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS | 0.90 |
| Nodal Marginal Zone B-cell Lymphoma | Nodal Marginal Zone Lymphoma | ALIAS |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2'-F-ara-deoxyuridine | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacogenomic studies | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| positron emission tomography | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- I
- description
- Patients will receive a 1-hour infusion of FAU on days 1-5.
- interventionNames
- Drug: 2'-F-ara-deoxyuridine
- Other: positron emission tomography
- Other: laboratory biomarker analysis
- Other: pharmacological study
- Other: pharmacogenomic studies
Primary outcomes (1)
- measure
- 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
- timeFrame
- Up to 28 days
Secondary outcomes (2)
- measure
- Clinical response to FAU, evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Measurable disease by CT scan and/or MRI * Archival tumor tissue sample available for correlative pharmacodynamic and pharmacogenomic studies * Accessible tumor tissue available (for patients enrolled in the expanded maximum tolerated dose \[MTD\] cohort) * No known active brain metastases but previously treated brain metastases allowed * ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100% * AST and ALT =\< 2.5 times upper limit of normal (ULN) (=\< 5 times ULN if liver metastases are present) * Alkaline phosphatase =\< 2.0 times ULN (=\< 5 times ULN if bone or liver metastases are present) * Bilirubin normal * Creatinine normal or creatinine clearance \>= 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Willing to undergo tumor biopsies for correlative pharmacodynamic studies (for patients enrolled in the expanded MTD cohort) * Able to lie still for PET scan * Weight =\< 300 lbs * No uncontrolled illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness/social situation that would preclude compliance with study requirements * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to FAU * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin C, or bleomycin), immunotherapy, or experimental therapy and recovered * More than 4 weeks since prior radiotherapy to \> 5% of total marrow volume * No prior radiotherapy to \>= 50% of total marrow volume * More than 3 weeks since prior radiotherapy to =\< 5% of total marrow volume * No other concurrent investigational agents * ANC \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Life expectancy \> 12 weeks * Histologically or cytologically confirmed malignant solid tumor for which standard curative or palliative measures do not exist or are no longer effective * Solid hematologic malignancies (e.g., Hodgkin or non-Hodgkin lymphoma) allowed provided bone marrow biopsy has been performed within the past 6 weeks * Metastatic or unresectable disease * No other concurrent anticancer therapy (e.g., cytotoxic therapy, biologic therapy, radiotherapy, or hormonal therapy) * Concurrent hormone replacement therapy allowed * Concurrent megestrol acetate or bisphosphonates allowed provided they were started 1 month prior to study enrollment * Concurrent luteinizing hormone-releasing hormone agonists to maintain castrate levels of testosterone allowed for patients with prostate cancer
References
Publications (0)
Data not yet available
No reference posted for this study.