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Immunoconjugates

Citrate

sargramostim

cyclophosphamide

cytarabine

gemtuzumab ozogamicin

liposomal daunorubicin citrate

topotecan hydrochloride

Mark R. Litzow, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining more than one drug or combining monoclonal antibody with chemotherapy may kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia.

PURPOSE: Randomized phase II trial to compare the effectiveness of three treatment regimens in treating patients who have relapsed or refractory acute myelogenous leukemia.

OBJECTIVES:

* Compare the rates of complete response (CR) and CR without full platelet recovery in patients with relapsed or refractory acute myelogenous leukemia treated with gemtuzumab ozogamicin and cytarabine vs daunorubicin liposomal and cytarabine vs cyclophosphamide, cytarabine, and topotecan.
* Compare the toxicities of these 3 regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by disease status (relapse less than 6 months after first complete response (CR) vs relapse 6-12 months after first CR vs refractory to conventional initial induction chemotherapy (no more than 2 courses) or first reinduction (no more than 1 course) vs second or greater relapse).

* Induction: Patients are randomized to 1 of 3 treatment arms:

  * Arm I: Patients receive cytarabine IV over 2 hours on days 1-4 and gemtuzumab ozogamicin IV over 2 hours on day 5.
  * Arm II: Patients receive daunorubicin liposomal IV over a minimum of 2 hours on days 1-3 and cytarabine IV over 2 hours (beginning immediately after completion of daunorubicin liposomal infusion) on days 1-4.
  * Arm III: Patients receive cyclophosphamide IV over 1 hour every 12 hours on days 1-3, cytarabine IV over 2 hours (beginning immediately after completion of cyclophosphamide infusion) on days 2-6, and topotecan IV continuously on days 2-6.
* Consolidation: Patients who achieve complete remission (CR) receive 1 additional course of induction therapy on the same arm to which they were originally randomized beginning within 4-6 weeks after initial documentation of CR. Patients on arm II receive no additional daunorubicin liposomal if resting ejection fraction is less than 50% preconsolidation. All patients receive sargramostim (GM-CSF) IV over 4 hours or SQ daily beginning 24 hours after completion of consolidation therapy and continuing until blood counts recover.

Patients are followed every 3 months through year 2, every 6 months through year 5, and then annually thereafter until death.

PROJECTED ACCRUAL: A maximum of 150-165 patients (50-55 per arm) will be accrued for this study within 2 years.

Comparison of Three Treatment Regimens in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia

A Phase II Randomized Trial of Immunologic and Chemotherapeutic Agents for Treatment of Patients With Relapsed or Refractory Acute Myelogenous Leukemia

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Syndrome

Preleukemia

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Myelodysplastic Syndromes

Anemia

Hematologic Neoplasms

Anemia, Refractory, with Excess of Blasts

Anemia, Refractory

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Disease Attributes

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Chronic Graft Versus Host Disease

Myelodysplastic Syndrome With Excess Blasts

Chronic Myeloproliferative Disorders

Myelodysplastic/myeloproliferative Disease

Semaxinib

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.

semaxanib

laboratory biomarker analysis

Francis Giles

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

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.

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

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

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Kenneth O'Byrne, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of liposomal daunorubicin in treating patients who have metastatic breast cancer.

OBJECTIVES: I. Determine the maximum tolerated dose of daunorubicin liposomal in patients with metastatic breast cancer. II. Assess the antineoplastic activity and safety profile of this regimen in these patients.

OUTLINE: This is a dose escalation study. Patients receive daunorubicin liposomal IV over a minimum of 2 hours on day 1. Treatment repeats every 3 weeks for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of daunorubicin liposomal until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity. Patients with stable or responding disease are followed at 1 and 3 months, then every 3 months for 1 year.

PROJECTED ACCRUAL: Approximately 15-20 patients will be accrued for this study within 1 year.

Liposomal Daunorubicin in Treating Patients With Metastatic Breast Cancer

A Phase I Study to Determine the Maximum Tolerated Dose of Daunoxome as Therapy for the Treatment of Metastatic Breast Cancer

University of Leicester

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Three Treatment Regimens in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia	NCT00005962	Leukemia	sargramostim cyclophosphamid... cytarabine gemtuzumab ozog... liposomal dauno... topotecan hydro...	18 Years - 120 Years	Eastern Cooperative Oncology Group
Comparison of Three Treatment Regimens in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia	NCT00005962	Leukemia	sargramostim cyclophosphamid... cytarabine gemtuzumab ozog... liposomal dauno... topotecan hydro...	18 Years - 120 Years	Eastern Cooperative Oncology Group
Liposomal Daunorubicin and SU5416 in Treating Patients With Hematologic Cancer That Has Not Responded to Initial Therapy	NCT00005942	Chronic Myelomo... Previously Trea... Recurrent Adult... Refractory Anem... Refractory Anem...	liposomal dauno... semaxanib laboratory biom...	18 Years -	National Cancer Institute (NCI)
Liposomal Daunorubicin in Treating Patients With Metastatic Breast Cancer	NCT00004207	Breast Cancer	liposomal dauno...	18 Years -	National Cancer Institute (NCI)

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