Oblimersen and Gemtuzumab Ozogamicin in Treating Older Patients With Relapsed Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00017589
First received: June 6, 2001
Last updated: January 3, 2014
Last verified: April 2003
  Purpose

RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Oblimersen may help gemtuzumab ozogamicin kill more cancer cells by making cancer cells more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of combining oblimersen and gemtuzumab ozogamicin in treating older patients who have relapsed acute myeloid leukemia.


Condition Intervention Phase
Leukemia
Biological: oblimersen sodium
Drug: gemtuzumab ozogamicin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Genasense (Bcl-2 Antisense) Combined With Mylotarg (Gemtuzumab Ozogamicin) in Elderly Patients With Relapsed Acute Myeloid Leukemia

Resource links provided by NLM:


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

Study Start Date: December 2000
Study Completion Date: May 2006
Detailed Description:

OBJECTIVES:

  • Determine the complete response rate of elderly patients with relapsed CD33-positive acute myeloid leukemia treated with oblimersen and gemtuzumab ozogamicin.
  • Determine the overall response rate and duration of response of patients treated with this regimen.
  • Determine the safety of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oblimersen IV continuously on days 1-7 and 15-22 and gemtuzumab ozogamicin IV over 2 hours on days 4 and 18.

Patients are followed monthly for 6 months.

PROJECTED ACCRUAL: A total of 20-100 patients will be accrued for this study within 1 year.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed CD33+ acute myeloid leukemia (AML)

    • In first relapse from chemotherapy
    • Complete response lasting at least 3 months before relapse
  • No CNS leukemia
  • No secondary leukemia or history of antecedent hematologic disorder prior to initial onset of AML (e.g., myelodysplasia)

PATIENT CHARACTERISTICS:

Age:

  • 60 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC less than 30,000/mm^3
  • No bleeding or coagulation disorder except disease-related disseminated intravascular coagulation

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • PT and PTT no greater than 1.5 times upper limit of normal OR
  • INR no greater than 1.3
  • No history of chronic hepatitis or cirrhosis

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No uncontrolled congestive heart failure
  • No New York Heart Association class III or IV heart disease

Pulmonary:

  • No severe pulmonary disease

Other:

  • HIV negative
  • No other concurrent medical disease that would preclude study entry
  • No known hypersensitivity to phosphorothioate-containing oligonucleotides, gemtuzumab ozogamicin or any of its components, E. coli protein, or any product produced in E. coli
  • No other concurrent malignancy
  • No known human anti-human antibodies
  • No uncontrolled seizure disorder
  • No active uncontrolled infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior allogeneic or autologous stem cell transplantation
  • No prior therapy with an anti-CD33 antibody (e.g., gemtuzumab ozogamicin or M195)

Chemotherapy:

  • See Disease Characteristics
  • At least 2 weeks since prior cancer chemotherapy except intrathecal chemotherapy or hydroxyurea

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 2 weeks since prior systemic radiotherapy

Surgery:

  • At least 2 weeks since prior major surgery
  • No prior organ allograft

Other:

  • At least 3 weeks since prior antileukemic therapy and recovered
  • No other concurrent investigational therapy
  • No concurrent immunosuppressive therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017589

Locations
United States, New Jersey
Genta Incorporated
Berkeley Heights, New Jersey, United States, 07922
Sponsors and Collaborators
Genta Incorporated
Investigators
Study Chair: Stanley R. Frankel, MD Genta Incorporated
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00017589     History of Changes
Other Study ID Numbers: CDR0000068721, GENTA-GA210, UCCRC-10928
Study First Received: June 6, 2001
Last Updated: January 3, 2014
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Gemtuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014