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Liposomal Daunorubicin and SU5416 in Treating Patients With Hematologic Cancer That Has Not Responded to Initial Therapy
This study has been completed.
First Received: July 5, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005942
  Purpose

RATIONALE: 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.

PURPOSE: 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.


Condition Intervention Phase
Leukemia
Myelodysplastic Syndromes
Drug: liposomal daunorubicin citrate
Drug: semaxanib
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2000
Detailed Description:

OBJECTIVES: I. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia, refractory anemia with excess blasts (RAEB), RAEB in transformation, or chronic myelomonocytic leukemia in transformation Not in complete remission 21-50 days after beginning course one of initial induction chemotherapy No more than 1 course of prior chemotherapy containing the following: Cytarabine at a dose of at least 1 g/m2 daily for 4 days AND Topotecan OR an anthracycline at standard doses: Daunorubicin no greater than 65 mg/m2 daily for 3 days OR Idarubicin 12 mg/m2 daily for 3 days Patients beginning study on days 21-42 of course one must have persistent blasts in bone marrow or blood with no evidence of improvement Patients beginning study on days 42-50 may or may not have persistent blasts but must have thrombocytopenia or neutropenia that is not improving No prior CNS hemorrhage

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0 or 1 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No uncompensated coronary artery disease No myocardial infarction or severe/unstable angina in the past 6 months LVEF at least 40% by MUGA or echocardiography No severe peripheral vascular disease No deep venous or arterial thrombosis within the past 3 months Pulmonary: No pulmonary embolism with the past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection No psychosis or mental disability that would preclude study No known allergy to Cremophor or Cremophor based drug products, corticosteroids, H1 blockers, H2 blockers, or paclitaxel No diabetes mellitus No acute or chronic medical or psychiatric condition, or laboratory abnormality, that would increase risks associated with study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior recombinant growth factors No concurrent biologic anticancer therapy No concurrent colony stimulating factors No prior angiogenesis inhibitor therapy (including metalloproteinase inhibitors, thalidomide, antiVEGF/Flk-1 monoclonal antibody therapy, or other investigational drugs which act on this pathway) Chemotherapy: See Disease Characteristics At least 2 weeks since prior chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior stereotactic CNS radiotherapy No concurrent systemic radiotherapy Surgery: At least 1 week since prior minor surgery At least 2 weeks since prior major surgery No concurrent surgery Other: No prior organ transplant At least 2 weeks since prior antibiotics At least 2 weeks since prior investigational agents No other concurrent investigational agents No concurrent antibiotics for active infection

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005942

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Francis J. Giles, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067822, MDA-ID-99341, NCI-673
Study First Received: July 5, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005942     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult acute myeloid leukemia
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
chronic myelomonocytic leukemia
previously treated myelodysplastic syndromes

Study placed in the following topic categories:
Daunorubicin
Chronic Myelomonocytic Leukemia
Precancerous Conditions
Hematologic Neoplasms
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Citric Acid
Myelodysplastic Syndromes
Anemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
SU 5416
Recurrence
Refractory Anemia
Anti-Bacterial Agents
Leukemia
Acute Myelocytic Leukemia
Preleukemia
Anemia, Refractory
Acute Myeloid Leukemia, Adult
Citrate
Anemia, Refractory, with Excess of Blasts
Bone Marrow Diseases

Additional relevant MeSH terms:
Daunorubicin
Neoplasms by Histologic Type
Disease
Precancerous Conditions
Antineoplastic Agents
Hematologic Diseases
Myelodysplastic Syndromes
Antibiotics, Antineoplastic
Pharmacologic Actions
Leukemia
Preleukemia
Neoplasms
Pathologic Processes
Therapeutic Uses
Syndrome
Bone Marrow Diseases

ClinicalTrials.gov processed this record on July 02, 2009