Bortezomib in Treating Patients With Waldenstrom's Macroglobulinemia

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

Sponsoren

Hauptsponsor: NCIC Clinical Trials Group

Mitarbeiter: National Cancer Institute (NCI)
Eastern Cooperative Oncology Group

Quelle National Cancer Institute (NCI)
Kurze Zusammenfassung

RATIONALE: Bortezomib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have untreated or relapsed Waldenstrom's macroglobulinemia.

detaillierte Beschreibung

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.

Gesamtstatus Completed
Anfangsdatum August 2002
Fertigstellungstermin December 2009
Primäres Abschlussdatum March 2006
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Response rate 4 years
Sekundäres Ergebnis
Messen Zeitfenster
Toxicity 4 years
Cytogenetics and genome profiling 4 years
Einschreibung 27
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: bortezomib

Beschreibung: PS-341 bolus intravenous injection twice weekly* for 2 out of every 3 weeks

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Christine I. Chen, MD Study Chair Princess Margaret Hospital, Canada
Ort
Einrichtung:
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois, 60521, United States
Abramson Cancer Center at the University of Pennsylvania | Philadelphia, Pennsylvania, 19104-4283, United States
Tom Baker Cancer Centre - Calgary | Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute | Edmonton, Alberta, T6G 1Z2, Canada
CancerCare Manitoba | Winnipeg, Manitoba, R3E 0V9, Canada
Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre | Halifax, Nova Scotia, B3H 1V7, Canada
Margaret and Charles Juravinski Cancer Centre | Hamilton, Ontario, L8V 5C2, Canada
Cancer Care Ontario-London Regional Cancer Centre | London, Ontario, N6A 4L6, Canada
Toronto Sunnybrook Regional Cancer Centre | Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital | Toronto, Ontario, M5G 2M9, Canada
Maisonneuve-Rosemont Hospital | Montreal, Quebec, H1T 2M4, Canada
Saskatoon Cancer Centre | Saskatoon, Saskatchewan, S7N 4H4, Canada
Standort Länder

Canada

United States

Überprüfungsdatum

September 2011

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Studiendesign Info

Zuweisung: Non-Randomized

Interventionsmodell: Single Group Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov