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A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Waldenstrom's Macroglobulinemia


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Waldenstrom's Macroglobulinemia


OBJECTIVES:

- Determine the efficacy of bortezomib, in terms of response rate, in patients with
previously untreated or relapsed Waldenstrom's macroglobulinemia.

- Determine the toxicity of this drug in these patients.

- Determine the time to progression, stable disease duration, and response duration in
patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat
every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks. Patients with complete or partial response or stable
disease are followed every 3 months thereafter.

PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 1.5-2
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of Waldenstrom's macroglobulinemia confirmed by immunofixation or
immunoelectrophoresis

- Newly diagnosed or untreated with IgM ≥ 20 g/L OR

- Previously treated with IgM ≥ 5 g/L

- Non-refractory, defined as no disease progression during prior therapy or within 4
weeks of the last dose of most recent prior therapy (12 weeks for rituximab)

- Must have 1 or more of the following:

- Symptomatic lymphadenopathy

- Hepatomegaly and/or splenomegaly

- Anemia (i.e., hemoglobin < 11.0 g/dL)

- Hyperviscosity syndrome

- No other lymphoproliferative disease including transformed aggressive lymphoma

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks

Hematopoietic

- See Disease Characteristics

- Absolute granulocyte count ≥ 1,000/mm^3

- Platelet count ≥ 50,000/mm^3

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST or ALT ≤ 2.5 times ULN

Renal

- Creatinine ≤ 1.5 times ULN

Other

- No uncontrolled bacterial, fungal, or viral infection

- No pre-existing sensory or motor neurotoxicity grade 2 or greater

- No other prior malignancy except adequately treated nonmelanoma skin cancer,
curatively treated carcinoma in situ of the cervix, or other curatively treated solid
tumor for which patient has been disease free for at least 5 years

- No other serious illness or medical condition that would preclude study participation

- No unreasonable geographical limitations

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Chemotherapy

- See Disease Characteristics

- At least 12 weeks since prior rituximab (for patients who have progressed)

- At least 24 weeks since prior rituximab (for patients who have not progressed)

- No prior high-dose chemotherapy and stem cell transplantation

- No prior radioactive monoclonal antibodies

Chemotherapy

- See Disease Characteristics

- See Biologic therapy

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

- No more than 2 prior chemotherapy regimens

- The same chemotherapy combination given for first-line and second-line therapy
is considered 2 regimens

- Single-agent rituximab not considered 1 prior regimen

- No concurrent cytotoxic chemotherapy

Endocrine therapy

- No concurrent corticosteroids

Radiotherapy

- At least 4 weeks since prior radiotherapy (except for low-dose, non- myelosuppressive
radiotherapy) and recovered

- No prior radiotherapy to more than 25% of bone marrow

Surgery

- At least 4 weeks since prior major surgery

Other

- At least 4 weeks since prior plasmapheresis

- At least 4 weeks since prior investigational anticancer therapy

- No other concurrent investigational anticancer agents or therapies

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

To assess the efficacy (response rate) of PS-341 given as a bolus intravenous injection twice weekly for two out of every 3 weeks in the treatment of a population of patients with previously untreated or relapsed Waldenström's Macroglobulinemia

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Christine I. Chen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

United States: Federal Government

Study ID:

I152

NCT ID:

NCT00045695

Start Date:

August 2002

Completion Date:

December 2009

Related Keywords:

  • Lymphoma
  • Waldenstrom macroglobulinemia
  • Lymphoma
  • Waldenstrom Macroglobulinemia

Name

Location

Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Abramson Cancer Center at the University of PennsylvaniaPhiladelphia, Pennsylvania  19104