Status:
COMPLETED
FAU in Treating Patients With Advanced Solid Tumors or Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Grade III Lymphomatoid Granulomatosis
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 si...
Detailed Description
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) o...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00769288
Start Date
July 1 2009
Last Update
January 7 2014
Active Locations (1)
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1
Wayne State University
Detroit, Michigan, United States, 48202