Clofarabine and Gemtuzumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT00577694 | Terminated Phase 1 DMC

• 4 other identifiers: LCCC 0708P30CA016086CDR0000580801UNC-LCCC-07-1222
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, 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 carry cancer-killing substances to them. Giving clofarabine together with gemtuzumab may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when given together with gemtuzumab in treating patients with relapsed or refractory acute myeloid leukemia.

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemia

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of clofarabine

  3 years

Secondary Outcomes (3)

• Rate of complete response and/or partial complete response with incomplete platelet recovery

  3 years

• Duration of remission

  5 years

• Frequency of patients proceeding to allogeneic or autologous blood or bone marrow stem cell transplantation

  5 years

Study Arms (1)

single arm study

OTHER

1

Drug: clofarabine; Drug: gemtuzumab ozogamicin

Interventions

clofarabine DRUG

Intravenous, 20mg/m2, Days 1, 2, 3, 4 and 5; 2 cycles

Also known as: Clolar

single arm study

gemtuzumab ozogamicin DRUG

Intravenous, 3mg/m2, Day 1, one cycle

Also known as: Mylotarg

single arm study

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria: * Refractory disease, defined as persistent or progressive disease after ≥ 2 induction regimens, including ≥ 1 course of high-dose cytarabine (ARA-C) * Relapsed disease that has recurred within 1 year of an ARA-C-containing chemotherapy regimen * No CNS disease requiring radiotherapy * Patients with neurological symptoms must undergo a lumbar puncture and a CT scan or MRI of the brain to exclude brain metastasis PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Total bilirubin ≤ 2.0 times upper limit of normal (ULN) * ALT and AST ≤ 2.0 times the ULN * Serum creatinine ≤ 1.0 mg/dL OR glomerular filtration rate \> 60 mL/min * INR ≤ 1.5 and aPTT within ULN * Patients receiving anticoagulation therapy (e.g., warfarin or heparin) are eligible provided anticoagulation therapy can be discontinued or changed to parenteral medications while the platelet count is less than 50,000/mm³ * Negative pregnancy test * Fertile patients must use effective contraception * No concurrent active second primary malignancy (excluding superficial, non-invasive skin cancers) * No active bleeding diathesis, not including closely monitored therapeutic anticoagulation * No cardiac disease, including any of the following: * New York Heart Association class II-IV congestive heart failure * Unstable angina (i.e., anginal symptoms at rest) * New onset angina (i.e., began within the past 3 months) * Myocardial infarction within the past 6 months * No active clinically serious infection \> grade 2 * No cerebrovascular accident, including transient ischemic attacks, within the past 6 months * No pulmonary hemorrhage ≥ grade 2 within the past 4 weeks * No other hemorrhage or bleeding event ≥ grade 3 within the past 4 weeks * No known HIV infection or chronic hepatitis B or C * No serious non-healing wound or ulcer * More than 4 weeks since prior significant traumatic injury * No prior history of sinusoidal obstructive syndrome (veno-occlusive disease) PRIOR CONCURRENT THERAPY: * More than 4 weeks since prior major surgery or open biopsy * More than 100 days since any prior hematopoietic stem cell transplant * No concurrent treatment with any other investigational agent for AML * Intrathecal chemotherapy administration is allow for central nervous system leukemic infiltration * No prior allogeneic stem cell transplant within the past 100 days, with active graft-versus-host disease (GVHD) of any grade, or exposure to immynosuppression for GVHD or prophylaxis

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute

Interventions

Clofarabine; Gemtuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nucleotides; Ribonucleotides; Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Thomas C. Shea, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 20, 2007
• Study Start: November 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2015
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

US (1)