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Status:

TERMINATED

Vaccine Therapy and Sargramostim Compared With Placebo and Sargramostim Following Rituximab in Treating Patients With Non-Hodgkin's Lymphoma

Lead Sponsor:

Favrille

Conditions:

Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Vaccines made from a person's...

Detailed Description

OBJECTIVES: Primary * Compare time to disease progression in patients with grade 1, 2, or 3 follicular B-cell non-Hodgkin's lymphoma who respond (i.e., complete or partial response, or stable diseas...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL)
  • Grade 1, 2, or 3
  • Meets 1 of the following criteria for treatment with rituximab:
  • Treatment naïve
  • Relapsed or refractory disease after prior chemotherapy
  • Relapsed after a prior documented response (i.e., complete or partial response) to rituximab of at least 6 months duration
  • Tumor accessible for biopsy OR existing biopsy material (taken within the past 6 months) suitable for vaccine preparation
  • Measurable or evaluable disease after tumor tissue procurement for vaccine production
  • No more than 2 prior treatment regimens for NHL
  • Single regimens include any of the following:
  • Maintenance rituximab
  • Rituximab administered once weekly for 8 courses
  • Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) plus rituximab\* NOTE: \*CHOP followed by rituximab at time of relapse is considered 2 treatment regimens
  • No history of CNS lymphoma or meningeal lymphomatosis
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-1
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute granulocyte count ≥ 1,500/mm\^3
  • Platelet count ≥ 75,000/mm\^3 (unless related to bone marrow involvement by lymphoma)
  • Hemoglobin ≥ 10g/dL
  • Hepatic
  • Not specified
  • Renal
  • Not specified
  • Cardiovascular
  • No congestive heart failure
  • Pulmonary
  • No compromised pulmonary function
  • Immunologic
  • HIV negative
  • No prior allergic response to GM-CSF
  • No active bacterial, viral, or fungal infection
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No psychiatric disorder that would preclude study participation
  • No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No other serious nonmalignant disease that would preclude study participation
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • See Disease Characteristics
  • See Chemotherapy
  • At least 4 weeks since prior immunotherapy
  • No prior radiolabeled anti-lymphoma antibody (e.g., iodine I 131 tositumomab or ibritumomab tiuxetan)
  • No prior autologous or allogeneic stem cell transplantation
  • No prior lymphoma-specific idiotype immunotherapy (e.g., Id vaccine)
  • No prior investigational vaccine or immunotherapeutic containing keyhole limpet hemocyanin (KLH)
  • Chemotherapy
  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy
  • More than 9 months since prior fludarabine
  • More than 2 years since prior chemotherapy/rituximab combination therapy (e.g., CHOP/rituximab or cyclophosphamide, vincristine, and prednisone \[CVP\]/rituximab)
  • No more than 6 total prior treatment courses with fludarabine
  • Endocrine therapy
  • No concurrent steroids for allergic reaction to sargramostim (GM-CSF)
  • Radiotherapy
  • See Biologic therapy
  • At least 4 weeks since prior radiotherapy
  • Surgery
  • Not specified
  • Other
  • At least 4 weeks since prior experimental therapy
  • No concurrent systemic immunosuppressive therapy
  • No other concurrent anti-lymphoma therapy

Exclusion

    Key Trial Info

    Start Date :

    July 1 2004

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00089115

    Start Date

    July 1 2004

    Last Update

    August 2 2013

    Active Locations (60)

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

    Page 1 of 15 (60 locations)

    1

    Comprehensive Cancer Center at University of Alabama at Birmingham

    Birmingham, Alabama, United States, 35294

    2

    Mayo Clinic Scottsdale

    Scottsdale, Arizona, United States, 85259

    3

    Tower Cancer Research Foundation

    Beverly Hills, California, United States, 90211

    4

    Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, United States, 92093-0658