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LeukemiaPhase 1NCT00024180

FR901228 in Treating Patients With Hematologic Cancer

A Phase 1 study testing romidepsin in people with Leukemia and Lymphoma, run by Ohio State University Comprehensive Cancer Center 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

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of FR901228 in treating patients who have hematologic cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Lymphoma
What is being tested?
romidepsin
How many people
Not given
Where
1 siteUnited States
Study dates
Jan 2002to Aug 2006
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

DISEASE CHARACTERISTICS:

  • Diagnosis of one of the following hematologic malignancies:
  • Chronic lymphocytic leukemia (CLL)
  • Small lymphocytic lymphoma (SLL) (including Waldenstrom's macroglobulinemia)
  • Acute myeloid leukemia (AML)
  • Acute lymphoblastic leukemia (ALL)
  • Stratum I (CLL and SLL):
  • Received at least one prior therapy containing a purine analog OR
  • Received another form of therapy (including alkylating agents) due to history of severe autoimmune disease, requirement for chronic corticosteroid, or other contraindication to purine analog therapy
  • Stratum II (AML and ALL):
  • Primary refractory or relapsed leukemia within the past year that is not amenable to curative therapy
  • OR
  • Untreated or previously treated poor-risk leukemia defined by any of the following:
  • 65 years of age and over
  • Poor-risk candidates for aggressive chemotherapy
  • Poor-risk cytogenetics (for AML, karyotype abnormalities other than t(8;21), inv(16), t(15;17))

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Stratum I only:
  • No uncontrolled autoimmune hemolytic anemia
  • No idiopathic thrombocytopenic purpura
  • Stratum II only:
  • WBC no greater than 10,000/mm^3 OR
  • WBC no greater than 40,000/mm^3 that is stable for at least 1 week (may be sustained by hydroxyurea through the first week of study)

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • ALT and AST no greater than 3 times upper limit of normal

Renal:

  • Creatinine less than 2.0 mg/dL

Cardiovascular:

  • Ejection fraction at least 50% by MUGA
  • No myocardial infarction or unstable angina within the past 6 months
  • No prior unstable ventricular or supraventricular cardiac arrhythmias

Other:

  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other medical or psychiatric problem that would preclude study
  • Stratum I only:
  • No active infection requiring oral or IV antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • At least 28 days since prior chemotherapy (except hydroxyurea)
  • At least 6 weeks since prior nitrosoureas
  • At least 8 weeks since prior UCN-01 (unless plasma UCN-01 level less than 1 uM)

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • At least 28 days since prior radiotherapy

Surgery:

  • At least 28 days since prior major surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210-1240

Other trials in United States

About this study

Official title: A Phase I Study of Depsipeptide in Selected Hematologic Malignancies (NSC 630176)

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of FR901228 in treating patients who have hematologic cancer.

Read the detailed description

OBJECTIVES:

  • Determine the in vivo biologic effect of FR901228 (depsipeptide) in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, acute myeloid leukemia, or acute lymphoblastic leukemia.
  • Determine the pharmacokinetics and cellular pharmacodynamics of this drug in these patients.
  • Determine any preliminary anti-tumor activity of this drug in these patients.

OUTLINE: This is a dose-decreasing, multicenter study. Patients are stratified according to disease (chronic lymphocytic leukemia and small lymphocytic lymphoma vs acute myeloid leukemia and acute lymphoblastic leukemia).

Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

Cohorts of 10 patients per stratum receive decreasing doses of FR901228 until the minimal active dose is determined. If 5 or more patients show clinical or biological response, the subsequent cohort is treated at a lower dose. If fewer than 5 patients respond, the subsequent cohort is treated at a higher dose.

PROJECTED ACCRUAL: A minimum of 20 patients (10 per stratum) will be accrued for this study.

Conditions
Leukemia, Lymphoma
Being tested
romidepsin
Keywords
Waldenström macroglobulinemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, refractory chronic lymphocytic leukemia, untreated adult acute lymphoblastic leukemia, untreated adult acute myeloid leukemia, recurrent small lymphocytic lymphoma
Medical subject headings
Leukemia, Lymphoma, Waldenstrom Macroglobulinemia, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • romidepsinDrug

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startJan 2002
  3. Study completionAug 2006

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00024180
Sponsor's protocol ID
CDR0000068898
Other IDs
OSU-00H0350, NCI-27
Status last verified
Nov 2002
First submitted
13 Sep 2001
Last updated
31 Jan 2013
Results posted
No

Publications

  • Byrd JC, Marcucci G, Parthun MR, Xiao JJ, Klisovic RB, Moran M, Lin TS, Liu S, Sklenar AR, Davis ME, Lucas DM, Fischer B, Shank R, Tejaswi SL, Binkley P, Wright J, Chan KK, Grever MR. A phase 1 and pharmacodynamic study of depsipeptide (FK228) in chronic lymphocytic leukemia and acute myeloid leukemia. Blood. 2005 Feb 1;105(3):959-67. doi: 10.1182/blood-2004-05-1693. Epub 2004 Oct 5.

    PubMed 15466934

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing romidepsin in people with Leukemia and Lymphoma, run by Ohio State University Comprehensive Cancer Center 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?

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 31 Jan 2013. 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00024180, which also lists 1 linked publication.

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 31 Jan 2013.

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