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Adult Grade III Lymphomatoid GranulomatosisPhase 1NCT00769288

FAU in Treating Patients With Advanced Solid Tumors or Lymphoma

A Phase 1 study testing 2'-F-ara-deoxyuridine, positron emission tomography and laboratory biomarker analysis in people with Adult Grade III Lymphomatoid Granulomatosis and Adult Nasal Type Extranodal NK/T-cell Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 side effects and best dose of FAU in treating patients with advanced solid tumors or lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
2'-F-ara-deoxyuridine, positron emission tomography and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
Jul 2009to Dec 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wayne State University

    Detroit, Michigan, 48202

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

  1. 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.

Being tested
2'-F-ara-deoxyuridine, positron emission tomography, laboratory biomarker analysis, pharmacological study, pharmacogenomic studies
Medical subject headings
Lymphoma, Extranodal NK-T-Cell, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Lymphoma, B-Cell, Marginal Zone, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2'-F-ara-deoxyuridineDrug

    Also called FAU

    Given IV

  • positron emission tomographyOther

    Also called FDG-PET, PET, PET scan, tomography, emission computed

    Correlative studies

  • laboratory biomarker analysisOther

    Correlative studies

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • pharmacogenomic studiesOther

    Also called Pharmacogenomic Study

    Correlative studies

Study groups in NCT00769288
Study groupRoleWhat they receive
IExperimentalPatients will receive a 1-hour infusion of FAU on days 1-5.
Receives: Drug: 2'-F-ara-deoxyuridine; Other: positron emission tomography; Other: laboratory biomarker analysis; Other: pharmacological study; Other: pharmacogenomic studies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 28 days

Secondary outcomes (2)

  1. 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.

    Measured: Up to 30 days

  2. 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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2008 (estimated)
  2. Study startJul 2009
  3. Primary completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00769288
Sponsor's protocol ID
NCI-2009-00248
Other IDs
NCI-2009-00248, CDR0000615651, WSU#2007-005, WSU-2007-005, 7916, P30CA022453, U01CA062487
Status last verified
Jan 2014
First submitted
8 Oct 2008
Last updated
7 Jan 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 2'-F-ara-deoxyuridine, positron emission tomography and laboratory biomarker analysis in people with Adult Grade III Lymphomatoid Granulomatosis and Adult Nasal Type Extranodal NK/T-cell Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 37 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00769288.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2014.

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