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LeukemiaPhase 1/2NCT00022048

Bevacizumab in Treating Patients With Myelodysplastic Syndrome

A Phase 1/2 study testing bevacizumab in people with Leukemia and Myelodysplastic Syndromes, run by Stanford University at 3 sites 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: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bevacizumab
How many people
Not given
Where
3 sitesUnited States
Study dates
Aug 2001to Nov 2004
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed myelodysplastic syndrome (MDS)
  • Refractory anemia (RA)
  • RA with excess blasts (RAEB)
  • RAEB in transformation
  • RA with ringed sideroblasts
  • Non-proliferative chronic myelomonocytic leukemia (WBC less than 12,000/mm^3)
  • At least 1 of the following cytopenias:
  • Untransfused hemoglobin no greater than 10.0 g/dL and/or red cell transfusion dependent
  • Absolute neutrophil count no greater than 1,800/mm^3 (neutropenia)
  • Platelet count no greater than 100,000/mm^3 (thrombocytopenia)
  • No secondary MDS
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2
  • Karnofsky 60-100%

Life expectancy:

  • More than 4 months

Hematopoietic:

  • See Disease Characteristics
  • Platelet count at least 20,000/mm^3
  • No hemorrhagic illness within the past 3 weeks
  • No hemolysis
  • No iron deficiency
  • No active blood loss

Hepatic:

  • AST and ALT no greater than 2.5 times upper limit of normal (ULN)
  • Bilirubin no greater than 2.0 mg/dL
  • INR less than 2.0
  • PTT less than 1.5 times ULN

Renal:

  • Creatinine no greater than 2.0 mg/dL
  • No renal dysfunction requiring dialysis within the past 6 months
  • No nephrotic syndrome within the past 6 months

Cardiovascular:

  • No myocardial infraction within the past 6 months
  • No severe or unstable angina within the past 6 months
  • No severe peripheral vascular disease (ischemic rest pain, non-healing wound or ulcer, or tissue loss) within the past 6 months
  • No uncontrolled hypertension within the past 6 months
  • No transient ischemic attack within the past 6 months
  • No cerebrovascular accident within the past 6 months
  • No deep venous or arterial thrombosis
  • No coronary artery disease
  • No symptomatic congestive heart failure (New York Heart Association class II-IV heart disease)
  • No cardiac arrhythmia
  • No vascular illness within the past 3 weeks

Pulmonary:

  • No pulmonary embolism

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other active malignancy except localized squamous cell or basal cell skin cancer
  • Prior cured malignancy allowed
  • No trauma within the past 3 weeks
  • No significant inflammatory disease within the past 3 weeks
  • No serious non-healing wound, ulcer, or bone fracture
  • No hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • No other active severe disease
  • No infection
  • No psychiatric illness or social situation that would preclude study compliance
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior allogeneic bone marrow transplantation
  • At least 30 days since prior biologic response modifiers
  • At least 30 days since prior hematopoietic growth factors
  • At least 30 days since prior thalidomide
  • No concurrent thalidomide
  • No other concurrent biologic response modifiers
  • No concurrent hematopoietic growth factors (including epoetin alfa)
  • Concurrent filgrastim (G-CSF) for febrile neutropenia allowed
  • Concurrent transfusions allowed

Chemotherapy:

  • At least 30 days since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • No concurrent corticosteroid therapy (more than 10 mg/day of prednisone or equivalent steroid dose) except for pre-medication for transfusions

Radiotherapy:

  • At least 30 days since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • At least 3 weeks since prior surgery (including biopsy of visceral organ)

Other:

  • At least 10 days since prior anticoagulants
  • No concurrent cytotoxic agents
  • No other concurrent investigational agents

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Stanford Cancer Center at Stanford University Medical Center

    Stanford, California, 94305-5750

  • Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: Safety and Efficacy Trial of Bevacizumab: Anti-VEGF Humanized Monoclonal Antibody (NSC 704865) Therapy for Myelodysplastic Syndrome (MDS)

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.

PURPOSE: This phase I/II trial is to see if bevacizumab works in treating patients who have myelodysplastic syndrome.

Read the detailed description

OBJECTIVES:

  • Determine the hematologic responses, including changes in hemoglobin levels, neutrophil counts, platelet counts, and percentage of bone marrow blasts, in patients with myelodysplastic syndrome treated with bevacizumab.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the tolerance in patients treated with this regimen.
  • Determine bone marrow cytogenetic responses in patients treated with this regimen.
  • Determine bone marrow microvessel density in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to International Prognostic Scoring System risk status (low (low or intermediate-1) vs high (intermediate-2 or high)).

Patients receive bevacizumab IV over 30-90 minutes. Treatment repeats every 2 weeks for 4-6 months in the absence of disease progression or unacceptable toxicity.

Patients are followed at weeks 1, 3, 5, 7, and 9.

PROJECTED ACCRUAL: A total of 16-25 patients will be accrued for this study within 2 years.

Being tested
bevacizumab
Keywords
refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasm, unclassifiable, atypical chronic myeloid leukemia, BCR-ABL1 negative
Medical subject headings
Leukemia, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Anemia, Refractory, Anemia, Refractory, with Excess of Blasts, Leukemia, Myelomonocytic, Chronic, Myeloproliferative Disorders, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

What participants receive

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

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 startAug 2001
  3. Study completionNov 2004

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00022048
Sponsor's protocol ID
SUMC-MDA-ID-01152
Other IDs
CDR0000068778, MDA-ID-01152, NCI-2771
Status last verified
Oct 2004
First submitted
10 Aug 2001
Last updated
15 May 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing bevacizumab in people with Leukemia and Myelodysplastic Syndromes, run by Stanford University at 3 sites 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 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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.

Where can I read the original study information?
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 15 May 2013.

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