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Phase II Trial of Rituxan(R) Plus FavId(TM) (Tumor-Specific Idiotype-KLH) and GM-CSF Immunotherapy in Patients With Grade 1 or 2 Follicular B-Cell Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma

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Trial Information

Phase II Trial of Rituxan(R) Plus FavId(TM) (Tumor-Specific Idiotype-KLH) and GM-CSF Immunotherapy in Patients With Grade 1 or 2 Follicular B-Cell Lymphoma


The purpose of this study is to evaluate the ability of patients treated with Rituxan® plus
FavId™ and GM-CSF to mount an immune response (humoral and/or cellular) to KLH and their
idiotype. Secondary objectives are the determination of overall objective response rate,
duration of response and time to progression. B-cell malignancies express a unique antigen,
the immunoglobulin idiotype (Id), on their surface. Each B-cell harbors a unique genetic
sequence used in production of unique Id protein. No normal B-cells possess that Id on their
cell surface. Hence, Id protein should serve as an ideal target for individualized active
immune therapy of NHL. Many of the antigens expressed by tumors (including Id) are only weak
immunogens. To augment the immune response against Id, the Id protein must be chemically
coupled to a strongly immunogenic protein. keyhole limpet hemocyanin (KLH) is a commonly
used protein carrier capable of augmenting the body's immune reaction against Id protein.
For vaccines which produce primarily an antibody response, there is a concern that combining
immunotherapy with Rituxan®, which produces a rapid and sustained (up to 6 to 9 months
post-treatment in 83% of patients) depletion of circulating and tissue-based B-cells, would
blunt any antibody response. For vaccines that induce strong T-cell responses like Id-KLH
plus GM-CSF, there is evidence in mice that depleting the host of B-cells could actually
increase the T-cell response to the vaccine. GM-CSF is a hematopoietic growth factor that
stimulates T-cell proliferation. T-cell response to both the patient's Idiotype and KLH
will be measured during this trial.

Inclusion Criteria


Inclusion Criteria

- 18 years of age or older

- Patients that are treatment naive OR

- Relapsed or refractory following chemotherapy OR

- Relapsed following a prior response to Rituxan(R) Note: Rituxan (R) may have been
given as second-line therapy following an initial response to chemotherapy or in
combination with chemotherapy for initial therapy of their disease.

- Tumor accessible for biopsy or previously existing recent biopsy material

- Measurable disease after node biopsy

- Histologically confirmed grade 1 or 2 follicular B-cell lymphoma (WHO classification)

- Performance status (ECOG) of 0, 1 or 2

- Absolute Granulocyte count > 1,000/mm3

- Platelets > 100,000/mm3

- Total Bilirubin <2 mg/dL

- AST and ALT <2x Upper Limit of Normal

- Creatinine < 1.5 mg/dL

Exclusion Criteria

- Patients who are refractory to Rituxan(R) Note: Patients who did not attain a CR or
PR are considered to be refractory

- More than 2 prior treatment regimens (e.g. CHOP plus Rituxan(R) is one treatment
regimen; CHOP followed by Rituxan(R) at initial relapse equals two treatment
regimens)

- Treatment w/Fludarabine within 9 months of study entry

- Patients with > 5,000 lymphocytes

- Prior tumor-specific idiotype immunotherapy using the identical idiotype (patients
whose idiotype has changed are eligible for retreatment with new idiotype)

- Concurrent immunosuppressive therapy (high-dose steroids; ect.)

- Known history of CNS lymphoma or meningeal lymphomatosis

- HIV positive

- Serious non-malignant disease (e.g., psychiatric disorders, compromised pulmonary
function (e.g. active asthma, COPD, pneumonitis, bronchiolitis obliterans),
congestive heart failure, or active uncontrolled bacterial, viral or fungal
infections), or other conditions which, in the opinion of the investigator would
compromise protocol objectives

- Prior malignancy (excluding non-melanoma carcinomas of the skin and in situ cervical
carcinomas) unless in remission for >2 years

- Treatment with an investigational drug within 8 weeks prior to study entry

- Pregnant or nursing women NOTE: Women of childbearing potential should be advised to
avoid becoming pregnant while receiving study treatment.

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

FavId-04

NCT ID:

NCT00041730

Start Date:

July 2002

Completion Date:

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • lymphoma
  • vaccine
  • idiotype
  • KLH
  • GM-CSF
  • FavId
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Henry Ford HospitalDetroit, Michigan  48202
Tower Hematology Oncology Medical GroupLos Angeles, California  90048
University of VirginiaCharlottesville, Virginia  22908
Northwestern UniversityChicago, Illinois  60611
The Ohio State UniversityColumbus, Ohio  43210
H. Lee Moffitt Cancer CenterTampa, Florida  33612
The Sarah Cannon Cancer CenterNashville, Tennessee  37203
Oncology Associates of San DiegoSan Diego, California  92123
University of Florida, JacksonvilleJacksonville, Florida  32209
New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer CenterBronx, New York  10466
University of California, San DiegoLa Jolla, California  92037-1709
University California, San FranciscoSan Francisco, California  94143
Ochsner Clinical FoundationNew Orleans, Louisiana  70121
Oncology/Hematology Care Clinical Cancer InstituteCincinnati, Ohio  45219
University Hospitals of Cleveland Case Western, Ireland Cancer CenterCleveland, Ohio  44106