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Status:

COMPLETED

Bortezomib, Rituximab, Cyclophosphamide, and Prednisone in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

Lead Sponsor:

Memorial Sloan Kettering Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Rutgers Cancer Institute of New Jersey

Conditions:

Leukemia

Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and prednisone, work in different...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose of bortezomib when given in combination with rituximab, cyclophosphamide, and prednisone (R-CP) in patients with relapsed or refractory ind...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed diagnosis of 1 of the following:
  • Chronic lymphocytic leukemia (CLL)
  • B-cell small lymphocytic leukemia (SLL)
  • Any marginal zone lymphoma
  • Grade 1-3A follicular lymphoma
  • Waldenstrom's macroglobulinemia
  • Mantle cell lymphoma
  • No transformed indolent lymphoma
  • Assessable disease (phase I)
  • Measurable disease (phase I and II), defined as ≥ one lesion that can be accurately measured in ≥ 1 dimension as ≥ 2 cm by conventional techniques OR ≥ 1 cm by spiral CT scan
  • Lymph nodes measuring ≤ 1 cm in the short axis are considered normal
  • Relapsed or refractory disease
  • Must have received at least 1 prior therapeutic regimen but no more than 3 prior conventional cytotoxic therapy regimens
  • No known brain metastases or meningeal disease
  • PATIENT CHARACTERISTICS:
  • Karnofsky performance status \> 50%
  • Absolute neutrophil count \> 1,000/mcl (more than 500/mcl if known lymphomatous involvement)
  • Platelet count ≥ 50,000/mcl
  • Total bilirubin \< 1.5 times upper limit of normal (ULN) (less than 5 mg/dL if known history of Gilbert's disease)
  • AST and ALT ≤ 2.5 times ULN (4 times ULN if liver involvement)
  • Creatinine \< 1.5 times ULN OR creatinine clearance \> 50 mL/min
  • Patients may have febrile episodes up to 38.5ºC without evidence of active infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No New York Heart Association class III or IV congestive heart failure
  • No uncontrolled intercurrent illness, including any of the following:
  • Ongoing or active infection
  • Cerebrovascular accident or transient ischemic attack within 6 months of study entry
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • EKG evidence of acute ischemia
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • No uncontrolled hypertension requiring active manipulation of antihypertensive medications
  • No known or active HIV infection
  • No history of hypersensitivity to bortezomib, boron, or mannitol
  • No peripheral neuropathy \> grade 2
  • No other malignancy within the past 5 years except curatively treated non life-threatening malignancies, such as cutaneous basal cell or squamous cell carcinoma or carcinoma in situ of the cervix
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • Recovered from prior therapy
  • Prior stem cell transplantation allowed
  • Preparative cytoreductive and high-dose therapies considered 1 prior therapy
  • At least 4 weeks since prior cytotoxic chemotherapy (6 weeks since prior nitrosoureas or mitomycin C)
  • At least 12 weeks since prior radioimmunotherapy
  • One prior course comprising tositumomab or ibritumomab tiuxetan allowed
  • At least 1 week since prior palliative steroids for NHL
  • No therapeutic monoclonal antibodies (e.g., rituximab, tositumomab, ibritumomab, alemtuzumab, etc.) within 3 months of study entry
  • Patients treated with monoclonal antibodies within 3 months allowed provided disease progressed on this therapy AND no treatment received 7 days prior to study entry
  • Seven days since prior rituximab (for patients enrolled in phase I portion)
  • No major surgery within 4 weeks of study entry
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy

Exclusion

    Key Trial Info

    Start Date :

    December 13 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 11 2018

    Estimated Enrollment :

    79 Patients enrolled

    Trial Details

    Trial ID

    NCT00295932

    Start Date

    December 13 2005

    End Date

    March 11 2018

    Last Update

    November 20 2018

    Active Locations (8)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (8 locations)

    1

    Winship Cancer Institute of Emory University

    Atlanta, Georgia, United States, 30322

    2

    Memorial Sloan-Kettering at Basking Ridge

    Basking Ridge, New Jersey, United States, 07920

    3

    Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, United States, 08903

    4

    Memorial Sloan-Kettering Cancer Center @ Suffolk

    Commack, New York, United States, 11725