Brief Title
DT PACE, Tandem Autologous Transplant, Maintenance Therapy for Waldenstrom's Macroglobulinemia Patients
Official Title
UARK 2002-10, A Phase II Study of DT PACE Induction, Followed by Tandem Autologous Transplant and Maintenance Therapy for Patients With Advanced and/or Symptomatic Waldenstrom's Macroglobulinemia
Brief Summary
The purpose of this study is to find out what the response is and the side effects are with
chemotherapy using a combination of drugs called D.T. PACE (Dexamethasone, Thalidomide,
cis-Platinum, Adriamycin, Cyclophosphamide, and Etoposide) + Rituxan, followed by two
autologous transplants.
Detailed Description
Approximately 25 patients, male or female, age 18 and older, regardless of race or ethnicity,
will participate in this study at UAMS (University of Arkansas for Medical Sciences) only.
Participants will receive two courses of chemotherapy with a regimen called DT PACE +
Rituxan. This regimen consists of 6 drugs: Dexamethasone, Thalidomide, cis-Platinum,
Adriamycin, Cyclophosphamide, and Etoposide.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Response Rates to a Brief Remission Induction Treatment With One or Two Courses of Melphalan-based High-dose Treatment (HDT)
Condition
Waldenstrom Macroglobulinemia
Intervention
DT PACE + Rituxan
Study Arms / Comparison Groups
DT PACE/auto transplant/maint therapy
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
12
Start Date
November 2002
Completion Date
February 2008
Primary Completion Date
February 2008
Eligibility Criteria
Inclusion Criteria:
- Patients must have a pathological diagnosis of Waldenstrom's Macroglobulinemia, with
advanced and/or symptomatic disease requiring therapy. At least one of the following
must be true: *Presence of cytopenias, defined as Hemoglobin < 11 gm%, or WBC <
2000/µl, or platelets < 100,000 µl; *Presence of extensive (>3 cm) or symptomatic
lymphadenopathy or hepatosplenomegaly; *Presence of B symptoms (night sweats, fever,
weight loss of >10% of the baseline); *Presence of severe neuropathy, not otherwise
explained; *Progressive disease (increase in "M" by > 50% while observed, and decrease
in hemoglobin by >2 gm%,and/or decrease in platelets by >50,000/µl, and/or increase in
lymphadenopathy); *Serum albumin <2.5 gm%; *Persistently elevated β-2M >3.0 in the
absence of renal impairment or active infection.
- Hyperviscosity will be treated (in addition to plasmapheresis) only in the presence of
any of the above
- All necessary baseline studies for determining eligibility must be obtained within 35
days prior to registration.
- Patients must have a performance status of 0-2 based on SWOG criteria. Patients with a
poor performance status (3-4), based solely on bone pain, will be eligible.
- Patients must not have significant co-morbid medical conditions or uncontrolled life
threatening infection.
- Patients with recent (< 6 months) myocardial infarction, unstable angina, difficult to
control congestive heart failure, uncontrolled hypertension, or difficult to control
cardiac arrythmias are ineligible. Ejection fraction by ECHO must be > 50% and must be
performed within 60 days prior to registration, unless the patient has received
chemotherapy within that period of time (dexamethasone and thalidomide excluded), in
which case the LVEF must be repeated.
- Patients must have a creatinine < 3 mg/dl and a creatinine clearance > 30 ml/minute.
Patients with a creatinine clearance of 30-50 ml will only receive a 50% cisplatin
dose.
- Patients must have adequate hepatic function defined as serum transaminases < 2 x ULN
and direct bilirubin < 2.0 mg/dl.
- Patients must be able to receive full doses of DT PACE, in the opinion of the treating
investigator, with the exception of: *Patients that have received prior adriamycin >
450 mg/m2 and LVEF < 55%. Adriamycin will be omitted in these patients; *Patients with
a creatinine clearance 30 - 50 ml/minute, who will receive 50% of the cisplatin dose.
- Patients must not have a history of chronic obstructive or chronic restrictive
pulmonary disease. Patients must have adequate pulmonary function studies > 50% of
predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) > 50%
of predicted. Patients unable to complete pulmonary function tests due to myeloma
related pain or fracture must have a high resolution CT scan of the chest and must
also have acceptable arterial blood gases defined as PO2 greater than 70.
Exclusion Criteria:
- No prior malignancy is allowed except for adequately treated basal cell or squamous
cell skin cancer, in situ cervical cancer, or other cancer for which the patient has
been disease free for at least three years. Prior malignancy is acceptable provided
there has been no evidence of disease within the three-year interval.
- Pregnant or nursing women may not participate. Women of childbearing potential must
have a negative pregnancy test documented within one week of registration. Women/men
of reproductive potential may not participate unless they have agreed to use an
effective contraceptive method.
- All patients must be informed of the investigational nature of this study and must
sign and give written informed consent in accordance with institutional and federal
guidelines.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Bart Barlogie, MD, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00107614
Organization ID
UARK 2002-10
Responsible Party
Sponsor
Study Sponsor
University of Arkansas
Study Sponsor
Bart Barlogie, MD, PhD, Principal Investigator, UAMS
Verification Date
August 2011