Oblimersen in Treating Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia

NCT00062244 | Completed Phase 1

• 6 other identifiers: NCI-2012-01437MC0285MAYO-MC0285NCI-5826CDR0000304634N01CM17104
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 8

Brief Summary

This phase I/II trial is studying the side effects and best dose of oblimersen and to see how well it works in treating patients with relapsed or refractory Waldenstrom's macroglobulinemia. Biological therapies such as oblimersen may interfere with the growth of the cancer cells and slow or stop the growth of Waldenstrom's macroglobulinemia.

Conditions

Waldenström Macroglobulinemia

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose determined by the number of dose-limiting toxicity incidents graded according to CTC standard toxicity (Phase I)

  Hematologic dose-limiting toxicity measures will be assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization.

  21 days

Secondary Outcomes (5)

• Adverse events that are classified as either possibly, probably, or definitely related to study treatment (Phase II)

  Up to 2 years

• Proportion of overall confirmed responses (CR + PR) associated with G3139 (Phase II)

  6 months

• Time to progression

  Time from registration to the time of progression, assessed up to 2 years

• Overall survival

  Time from registration to death due to any cause, assessed up to 2 years

• Duration of response

  From the documentation of response until the date of progression, assessed up to 2 years

Study Arms (1)

Arm I

EXPERIMENTAL

Phase I: Patients receive oblimersen IV continuously on days 1-7. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of oblimersen 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. Phase II: Patients receive treatment as in phase I at the MTD of oblimersen. Patients are followed every 3 months for 2 years.

Biological: oblimersen sodium

Interventions

oblimersen sodium BIOLOGICAL

Given IV

Also known as: augmerosen, G3139, G3139 bcl-2 antisense oligodeoxynucleotide, Genasense

Arm I

Eligibility Criteria

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

You may qualify if:

• Diagnosis of Waldenstrom's macroglobulinemia (WM) confirmed by both of the following:
• Bone marrow lymphoplasmacytosis with greater than 10% lymphoplasmacytic cells or aggregates, sheets, lymphocytes, plasma cells, or lymphoplasmacytic cells on bone marrow biopsy
• Measurable disease, defined by quantitative IgM monoclonal protein greater than 1,000 mg/dL
• Symptomatic relapsed or refractory disease requiring therapy, defined by at least 1 of the following:
• Impaired bone marrow function due to disease infiltration as demonstrated by any of the following:
• Hemoglobin less than 11 g/dL
• Requires epoetin alfa therapy to maintain hemoglobin of at least 11 g/dL
• Platelet count less than 100,000/mm\^3
• Symptomatic bulky lymphadenopathy
• Symptoms attributable to hyperviscosity (e.g., nose bleeding, gingival bleeding, or retinal hemorrhage) or serum viscosity level relative to water greater than 4
• Received at least 1 prior chemotherapy regimen which included chlorambucil, cyclophosphamide, fludarabine, cladribine, or pentostatin
• No secondary leukemia or history of antecedent hematologic disorder (e.g., myelodysplasia) prior to initial onset of WM
• Performance status - ECOG 0-2
• Not specified
• See Disease Characteristics

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (8)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Howard University Hospital

Washington D.C., District of Columbia, 20060, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, 21201-1595, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287-8936, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

oblimersen

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Morie Gertz

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

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: June 5, 2003
• First Posted: June 6, 2003
• Study Start: May 1, 2003
• Primary Completion: June 1, 2007
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

US (8)