CC-5013 and Rituximab in Waldenstrom's Macroglobulinemia - Full Text View

Purpose

The purpose of this study is to determine the number of patients with Waldenstrom's macroglobulinemia that will benefit from treatment with CC-5103 and rituximab, what the side effects are and how long the benefit will last.

Condition	Intervention	Phase
Waldenstrom's Macroglobulinemia	Drug: CC-5103 Drug: Rituximab	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study of CC-5103 and Rituximab in Waldenstrom's Macroglobulinemia

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Rituximab

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To define objective response, time to progression and safety for combined CC-5103 and rituximab therapy in Waldenstrom's macroglobulinemia patients. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To identify the mechanism(s) of action for combined CC-5103 and rituximab activity. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	September 2004
Study Completion Date:	April 2008
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Taken orally once a day for 21 days followed by 7 days of no CC-5103

Begins on week 2 of treatment and is given intravenously once a week for 4 weeks

Detailed Description:

The study drug CC-5103 will be administered orally once daily for 21 days followed by 7 days of no CC-5103 (this will be one 28 day treatment cycle). This cycle will repeat itself every 28 days as long as the patient is tolerating the medication and there is no disease progression.
Starting on the second week, patients will begin treatment with rituximab intravenously once a week for 4 weeks (week 2-5). Prior to each treatment, patients will receive medications to prevent or reduce the side effects of rituximab (benadryl, tylenol and possible decadron). During the infusion, the patients' blood pressure and pulse will be monitored frequently and the rate of infusion may decrease depending upon the side effects. Blood work will also be performed each week.
On week 12 the disease status will be evaluated. A physical exam, blood test, CT scan and bone marrow biopsy may be repeated if necessary to fully evaluate the disease. If the disease has gone away completely, some tests may be repeated again to confirm this.
If the disease has gotten worse after 12 weeks, then the patient will be removed from the study.
If the disease is stable or getting better, the patient will continue with therapy. During weeks 13-16 rituximab infusions will be repeated and CC-5103 will continue to be taken daily for 21 days followed by 7 days of rest. This 28 day cycle may be repeated until the patient has completed 48 weeks (12 months) of treatment as long as the side effects are acceptable and the disease does not progress.
All patients will undergo an off-study evaluation that includes a physical exam, blood work, CT scans and bone marrow biopsy. If the patient completes 78 weeks of therapy and the disease does not get worse, they will be evaluated every 12 weeks to determine the status of their disease for up to 2 years.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinicopathological diagnosis of Waldenstrom's macroglobulinemia using consensus panel criteria
Age 18 years or older
CD20 positive based on any previous bone marrow immunohistochemistry or flow cytometric analysis
All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study
Measurable disease, defined as presence of immunoglobulin M paraprotein with a minimum IgM level of equal to or greater than 2 times the upper limit of normal.
ECOG performance status of 0-2
Absolute neutrophil count ≥ 100,000,000/L
Platelet count ≥ 50,000,000,000/L
Hemoglobin > 8 g/dL
Serum creatinine < 2.5 mg/dL
Total bilirubin < 1.5 mg/dL
AST and ALT < 2.5 x ULN
Disease free of prior malignancies fir 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast

Exclusion Criteria:

Any serious medical condition, laboratory abnormality, or psychiatric illness
Pregnant or lactating women
Prior therapy with rituximab or CC-5103
Known hypersensitivity to thalidomide
Development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Concurrent use of other anti-cancer agents or treatments

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142168

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Dana-Farber Cancer Institute

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Celgene Corporation

Genentech

Investigators

Principal Investigator:

Steven Treon, MD, MA, PhD

Dana-Farber Cancer Insitute

More Information

No publications provided

Responsible Party:	Steven Treon, MD, MA, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00142168 History of Changes
Other Study ID Numbers:	04-158
Study First Received:	September 1, 2005
Last Updated:	June 23, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

CC-5103
rituximab
Waldenstrom's macroglobulinemia

Additional relevant MeSH terms:

Waldenstrom Macroglobulinemia
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 17, 2013