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
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
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Gemtuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014