Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Completed 18 and over NCI MDA-ID-99341 NCI-673, NCT00005942, 673

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.

Entry 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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Francis Giles, MD, Protocol chair		Ph: 713-792-7305; 800-392-1611 Email: fgiles@mdanderson.org

Registry Information
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
Trial Start Date		2000-03-17
Registered in ClinicalTrials.gov		NCT00005942
Date Submitted to PDQ		2000-03-24
Information Last Verified		2001-05-01
NCI Grant/Contract Number		CA16672

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