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A Phase II Study of Perifosine in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia


Phase 2
18 Years
N/A
Not Enrolling
Both
Waldenstrom's Macroglobulinemia

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Trial Information

A Phase II Study of Perifosine in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia


- Participants will be given study medication-dosing diaries for each treatment cycle.
Each treatment cycle lasts 28 days. Participants will receive 6 cycles of the study
treatment with perifosine and those 6 cycles will be given one after another.

- Medication will be taken orally once a day with food before going to bed and the dose
may be reduced or the schedule changed in the event that the participant experiences
side effects.

- On Day one of each cycle, routine blood tests and exams will be performed.

- At the end of cycle 2 the following procedures will be performed; history and physical
exam, routine blood tests, bone marrow aspirate and biopsy and CT scan.

- At the end of cycle 6 (end of study) the following procedures will be performed;
routine blood tests, history and physical exam, bone marrow biopsy and aspirate,
research bone marrow and blood samples and CT scan.

- Participants will be in this study for about 6 months and be followed every three years
for 2 more years. They may continue the study treatment indefinitely if there is no
disease progression at the discretion of the treating investigator.


Inclusion Criteria:



- 18 years of age or older

- Must have received prior therapy for their WM and have relapsed or refractory WM.
Any number of prior therapies is acceptable

- Measurable disease, defined as presence of immunoglobulin M paraprotein with a
minimum IgM level of equal to or greater than 2 times the ULN and over 10% of
lymphoplasmacytic cells in bone marrow

- ECOG Performance Status 0,1, or 2

- Laboratory values as described in the protocol

- Life expectancy of greater than 12 weeks

Exclusion Criteria:

- Uncontrolled infection

- Other active malignancies

- CNS involvement

- Cytotoxic chemotherapy less than 3 weeks, or biologic therapy less than 2 weeks, or
corticosteroids less than 2 weeks prior to registration.

- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy
considered investigational

- Pregnant or nursing women

- Known to be HIV positive

- Radiation therapy less than 2 weeks prior to registration

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response Rate Defined as Minimal, Partial or Complete Response in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia Receiving Daily Perifosine at 150mg Orally.

Outcome Description:

Participants will be formally evaluated for response after the second cycle and at each subsequent cycle using the criteria from the Second International Workshop on Waldenstrom's Macroglobulinemia. Response was determined through review of routine blood tests, serum protein electrophoresis with quantitative M-spike, quantitative IgM level, and serum free light chain as well as tumor measurements by CT scan and bone marrow aspirate/biopsy.

Outcome Time Frame:

participants were followed for response for the duration of the study, approximately 2 years

Safety Issue:

No

Principal Investigator

Irene Ghobrial, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

06-077

NCT ID:

NCT00422656

Start Date:

September 2006

Completion Date:

November 2012

Related Keywords:

  • Waldenstrom's Macroglobulinemia
  • relapsed Waldenstrom's Macroglobulinemia
  • refractory Waldenstrom's Macroglobulinemia
  • WM
  • perifosine
  • Waldenstrom Macroglobulinemia

Name

Location
Dana-Farber Cancer Institute Boston, Massachusetts  02115