Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

NCT00004862 | Completed Phase 1

• 5 other identifiers: NCI-2012-01399OSU-99H0257OSU-9977NCI-T99-0057CDR0000067515
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I trial to study the effectiveness of augmerosen plus fludarabine and cytarabine in treating patients who have refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Gene therapy such as augmerosen may make cancer cells more sensitive to chemotherapy drugs. Combining more than one drug with augmerosen may kill more cancer cells.

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemia; recurrent adult acute lymphoblastic leukemia

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive augmerosen IV continuously on days 1-10 and filgrastim (G-CSF) subcutaneously beginning on day 5 and continuing until blood counts recover. Patients receive fludarabine IV over 30 minutes followed 3.5 hours later by cytarabine IV over 4 hours on days 6-10. Patients who achieve complete response (CR) receive a second course beginning 4 weeks after completion of the first course. Patients who achieve CR and have a matched sibling or unrelated bone marrow donor may undergo allogeneic bone marrow transplantation. Cohorts of 3-6 patients receive escalating doses of fludarabine and cytarabine 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 toxicity.

Biological: filgrastim; Biological: oblimersen sodium; Drug: cytarabine; Drug: fludarabine phosphate

Interventions

filgrastim BIOLOGICAL

Arm I

oblimersen sodium BIOLOGICAL

Arm I

cytarabine DRUG

Arm I

fludarabine phosphate DRUG

Arm I

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically proven refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia * Marrow cellularity must be at least 20% * Must have diagnostic lumbar puncture and treatment with prophylactic intrathecal methotrexate within 1 week prior to entering study * No active CNS involvement * CNS involvement allowed if no residual leukemic cells are detected in CSF following intrathecal chemotherapy PATIENT CHARACTERISTICS: * Age: 16 and over * Performance status: ECOG 0-2 * Life expectancy: At least 4 weeks * Bilirubin no greater than 2 times upper limit of normal(ULN) * ALT and AST no greater than 2 times ULN * Alkaline phosphatase no greater than 2 times ULN\* * Unless attributable to malignancy * Creatinine no greater than 1.5 mg/dL unless attributable to malignancy * No symptomatic congestive heart failure * No unstable angina pectoris No or cardiac arrhythmia * Resting cardiac ejection fraction no less than 45% unless attributable to malignancy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception before and during study * No history of allergy to study medications * No uncontrolled concurrent illness * No active infection * No serious medical or psychiatric illness that would preclude informed consent or limit survival to less than 4 weeks PRIOR CONCURRENT THERAPY: * At least 2 weeks since prior chemotherapy except hydroxyurea * No concurrent corticosteroids except for grade 4 toxicity unresponsive to all other agents * At least 4 weeks since prior radiotherapy * No other concurrent investigational or standard agents or therapies for leukemia

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Filgrastim; oblimersen; Cytarabine; fludarabine phosphate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Guido Marcucci, MD

  Ohio State University Comprehensive Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 7, 2000
• First Posted: January 29, 2004
• Study Start: October 1, 1999
• Primary Completion: December 1, 2001
• Last Updated: February 1, 2013

Record last verified: 2002-05

Locations

US (1)