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Waldenström MacroglobulinemiaPhase 1/2NCT00062244

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

A Phase 1/2 study testing oblimersen sodium in people with Waldenström Macroglobulinemia, run by National Cancer Institute (NCI) at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Waldenström Macroglobulinemia
What is being tested?
oblimersen sodium
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
8 sitesUnited States
Study dates
May 2003to Jun 2007
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 59Show fewer
  • 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
  • Absolute neutrophil count at least 1,000/mm^3*
  • Platelet count at least 50,000/mm^3*
  • No bleeding disorder
  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST less than 1.5 times ULN
  • Albumin at least 2.5 g/dL
  • PT no greater than 1.5 times ULN
  • INR no greater than 1.3
  • PTT no greater than 1.5 times ULN
  • No history of chronic hepatitis or cirrhosis
  • Creatinine no greater than 2 times ULN
  • No uncontrolled congestive heart failure
  • No active symptoms of coronary artery disease, including the following:
  • Uncontrolled arrhythmias
  • Recurrent chest pain despite prophylactic medication
  • No New York Heart Association class III or IV heart disease
  • No grade 2 or greater cardiovascular signs and symptoms within the past 4 weeks
  • HIV negative
  • Direct Coombs' test negative
  • No autoimmune thrombocytopenia
  • No uncontrolled serious infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Adequate venous access for 7-day continuous infusion of study drug
  • Intellectual, emotional, and physical ability to maintain an ambulatory infusion pump
  • No other cancer except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other cancer from which the patient has been disease-free for at least 5 years
  • No known hypersensitivity to phosphorothioate-containing oligonucleotides
  • No uncontrolled seizure disorder
  • More than 21 days since prior immunotherapy for WM
  • More than 21 days since prior cytokine, biologic, or vaccine therapy for WM
  • More than 8 weeks since prior plasmapheresis or plasma exchange
  • No prior allogeneic stem cell transplantation
  • No concurrent plasmapheresis or plasma exchange
  • See Disease Characteristics
  • No concurrent corticosteroid therapy
  • More than 21 days since prior radiotherapy for WM
  • More than 21 days since prior major surgery for WM
  • No prior organ allograft
  • Recovered from all prior therapy
  • More than 21 days since other prior therapy for WM
  • No other concurrent investigational therapy
  • No concurrent immunosuppressive drugs
  • No concurrent therapeutic anticoagulation therapy

Who cannot join

None listed.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201-1595

  • Johns Hopkins University

    Baltimore, Maryland, 21287-8936

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Howard University Hospital

    Washington D.C., District of Columbia, 20060

Other trials in United States

About this study

Official title: Phase I/II Study of G3139 (Genasense) in Patients With Waldenstrom's Macroglobulinemia

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the maximally tolerated dose (MTD) and recommended dosing for Genasense in patients with relapsed or refractory WM following prior chemotherapy. (Phase I) II. To determine the response rate to Genasense in patients with relapsed or refractory WM following prior chemotherapy.

III. To determine the safety of Genasense in patients with relapsed or refractory WM following prior chemotherapy.

IV. To describe possible clinical benefit from Genasense treatment of relapsed or refractory WM including duration of response, survival, erythropoietin use, improvement in hemoglobin > 11 g/dl, and Improvement in platelet count > 100,000/mm^3.

OUTLINE: This is a multicenter, dose-escalation study.

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.

Being tested
oblimersen sodium
Medical subject headings
Waldenstrom Macroglobulinemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oblimersen sodiumBiological

    Also called augmerosen, G3139, G3139 bcl-2 antisense oligodeoxynucleotide, Genasense

    Given IV

Study groups in NCT00062244
Study groupRoleWhat they receive
Arm IExperimentalPhase 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.
Receives: Biological: oblimersen sodium

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 21 days

Secondary outcomes (5)

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

    The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.

    Measured: Up to 2 years

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

    The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

    Measured: 6 months

  3. Time to progression

    The distribution of time to progression will be estimated using the method of Kaplan-Meier.

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

  4. Overall survival

    The distribution of overall survival will be estimated using the method of Kaplan-Meier.

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

  5. Duration of response

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2003 (estimated)
  2. Study startMay 2003
  3. Primary completionJun 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00062244
Sponsor's protocol ID
NCI-2012-01437
Other IDs
MC0285, MAYO-MC0285, NCI-5826, CDR0000304634, N01CM17104
Status last verified
Jun 2013
First submitted
5 Jun 2003
Last updated
4 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing oblimersen sodium in people with Waldenström Macroglobulinemia, run by National Cancer Institute (NCI) at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 59 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose determined by the number of dose-limiting toxicity incidents graded according to CTC standard toxicity (Phase I) (time frame: 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00062244.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2013.

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