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Chronic Myelomonocytic LeukemiaPhase 1/2NCT00005942

Liposomal Daunorubicin and SU5416 in Treating Patients With Hematologic Cancer That Has Not Responded to Initial Therapy

A Phase 1/2 study testing liposomal daunorubicin citrate, semaxanib and laboratory biomarker analysis in people with Chronic Myelomonocytic Leukemia and Previously Treated Myelodysplastic Syndromes, 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

Phase I/II trial to study the effectiveness of liposomal daunorubicin and SU5416 in treating patients who have hematologic cancer that has not responded to initial therapy. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
liposomal daunorubicin citrate, semaxanib and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
Mar 2000to Dec 2000
Phase
Phase 1/2
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

  • Adult patients with AML, RAEB, RAEB-T or CMML-T that are not in CR 21-50 days after beginning course one of initial induction chemotherapy; patients may not have received more than 1 prior course of chemotherapy prior to study entry; this must contain Ara-C at a dose of at least 1 g/m^2 daily x 4 days and either topotecan or an anthracycline at standard doses (i.e., daunorubicin =< 65 mg/m^2 daily x 3 days, or idarubicin 12 mg/m^2 daily x 3 days); patients beginning liposomal Daunorubicin on days 21 to 42 of course one must have persistent blasts in bone marrow or blood without evidence of improvement; patients beginning liposomal Daunorubicin on days 42 to 50 may or may not have persistent blasts but must have thrombocytopenia or neutropenia that is not improving
  • Patients must have recovered from the toxic effects of prior therapy with a minimum interval of 14 days from prior therapy and must not have received recombinant growth factors during this period
  • Patients of any racial and ethnic group
  • Zubrod performance status =< 1
  • Total bilirubin value =< 1.5 mg/dL
  • Serum creatinine value =< 1.5 mg/dL
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  • Serum sGOT or sGPT =< 2.5 times the upper lim it of normal
  • Patients must agree to practice approved methods of birth control (if applicable)
  • Patients must provide written informed consent
  • Patients from any gender or ethnic background may be included; over the last 5 years, 356 patients with relapsed or refractory acute leukemias that would meet the eligibility criteria for this study have been treated at M.D. Anderson Cancer Center, for an annual average of 70 patients; the race (as defined by the patient on admission questionnaire) and sex distribution for these patients

Who cannot join

  • Concurrent cancer chemotherapy, systemic radiotherapy or surgery
  • Patients should not have any evidence of an active infectious process or be receiving antibiotic therapy for an infectious process, either documented or presumed, at the time of study entry or for 2 weeks prior to study entry
  • Because of the potential effects of SU5416 on the embryo, women with the potential to become pregnant, unless utilizing birth control, or who are pregnant are excluded from the study; a negative pregnancy test must be documented during the screening period for women of childbearing potential; breast-feeding women are excluded from this trial because of the potential toxicity to the child; men of childfathering potential should use a medically acceptable form of birth control while on study
  • Overt psychosis or mental disability or otherwise incompetent to give informed consent
  • Receipt of any of the following prior to SU5416 administration:
  • major surgery within 2 weeks; minor surgery within 1 week
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  • any previous angiogenesis inhibitor therapy (including metalloproteinase inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal antibody therapy or other investigational drugs which act directly on the VEGF/Flk-1 signaling pathway)
  • organ transplant at any time
  • Known allergy to Cremophor beta or Cremophor beta-based drug products, corticosteroids; H1 blockers, H2 blockers or paclitaxel; patients with uncompensated coronary artery disease on electrocardiogram or physical examination, or with a history of myocardial infarction or severe/unstable angina in the past 6 months are not eligible; patients with a cardiac left ventricular ejection fractions (LVEF) by MUGA or echocardiography of < 40% are not eligible
  • Patients with diabetes mellitus and others with severe peripheral vascular disease and patients who have had a deep venous or arterial thrombosis (including pulmonary embolism) within 3 months of entry are not eligible
  • Prior CNS hemorrhage or prior sterotactic CNS radiation
  • Any acute or chronic medical or psychiatric condition, or a laboratory abnormality that may increase the risks associated with study participation/study drug administration or may interfere with the interpretation of study results

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase II Trial of Liposomal Daunorubicin (Daunoxome) and SU5416 (NSC 696819) in Patients With AML, RAEB, RAEB-T or CMML in Transformation Refractory to One Course of Induction Chemotherapy

Phase I/II trial to study the effectiveness of liposomal daunorubicin and SU5416 in treating patients who have hematologic cancer that has not responded to initial therapy. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. SU5416 may stop the growth of hematologic cancer by stopping blood flow to the cancer

Read the detailed description

OBJECTIVES:

  1. Determine the maximum tolerated dose of SU5416 when administered with daunorubicin liposomal in patients with acute myeloid leukemia, refractory anemia with excess blasts (RAEB), RAEB in transformation, or chronic myelomonocytic leukemia not in complete remission 21-50 days after one course of induction chemotherapy.

II. Determine the efficacy of this regimen in these patients. III. Determine the qualitative and quantitative toxicities of this regimen in these patients.

OUTLINE: This is a dose escalation study of SU5416.

Patients receive daunorubicin liposomal IV over 6 hours on days 1-3 and SU5416 IV twice a week for 2 months. The second course is administered for 1 month, then treatment continues every 4-6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 1 year.

Being tested
liposomal daunorubicin citrate, semaxanib, laboratory biomarker analysis
Medical subject headings
Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, Anemia, Refractory, with Excess of Blasts

What participants receive

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

  • liposomal daunorubicin citrateDrug

    Also called daunorubicin liposomal, DaunoXome, liposomal daunorubicin

    Given IV

  • semaxanibDrug

    Also called semoxind, SU5416, Sugen 5416

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00005942
Study groupRoleWhat they receive
Treatment (liposomal danorubicin citrate, semaxanib)ExperimentalPatients receive daunorubicin liposomal IV over 6 hours on days 1-3 and SU5416 IV twice a week for 2 months. The second course is administered for 1 month, then treatment continues every 4-6 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: liposomal daunorubicin citrate; Drug: semaxanib; Other: laboratory biomarker analysis

What is being measured

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

  1. MTD of semaxanib defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities

    Graded according to NCI CTC version 2.0.

    Measured: 2 months

  2. Achievement of CR, defined as normalization of the peripheral blood and bone marrow with 5% or less blasts, normo-or hypercellular marrow, a granulocyte count of 1x 10^9 L or above, and a platelet count of 100 x 10^9 L or above

    Measured: Up to 1 year

Timeline

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

  1. First posted26 May 2004 (estimated)
  2. Study startMar 2000
  3. Primary completionDec 2000

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005942
Sponsor's protocol ID
NCI-2012-02329
Other IDs
ID99-341, CDR0000067822
Status last verified
Jan 2013
First submitted
5 Jul 2000
Last updated
23 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing liposomal daunorubicin citrate, semaxanib and laboratory biomarker analysis in people with Chronic Myelomonocytic Leukemia and Previously Treated Myelodysplastic Syndromes, 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 10 inclusion and 12 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 23 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

MTD of semaxanib defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities (time frame: 2 months). The study lists 2 primary outcomes in all. 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 NCT00005942.

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 23 Jan 2013.

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