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.
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
- Conditions the study is for
- Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- 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
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.
bevacizumabBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 2001
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Peter L. Greenberg, MD, Study chair, Stanford University
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
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Trial of Bevacizumab: Anti-VEGF Humanized Monoclonal Antibody (NSC 704865) Therapy for Myelodysplastic Syndrome (MDS)
- ClinicalTrials.gov ID
- NCT00022048
- Acronym / sponsor ID
- SUMC-MDA-ID-01152
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2001
- Study completion
- Nov 2004 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bevacizumab | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter L. Greenberg, MD study chair
Stanford University
3 sites in 1 country: see every site and its status.
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.