Phase II Trial of Rituxan Plus FavId (Tumor-Specific Idiotype-KLH) and GM-CSF Immunotherapy in Patients With Grade 1 or 2 Follicular B-Cell Lymphoma
18 Years
N/A
Both
Lymphoma
Trial Information
Phase II Trial of Rituxan Plus FavId (Tumor-Specific Idiotype-KLH) and GM-CSF Immunotherapy in Patients With Grade 1 or 2 Follicular B-Cell Lymphoma
OBJECTIVES:
- Compare the 9-month objective response rate of patients with recurrent or refractory
grade I or II follicular B-cell lymphoma treated with rituximab, autologous
immunoglobulin idiotype-KLH conjugate vaccine, and sargramostim (GM-CSF) vs historical
control patients who received rituximab alone.
- Compare the median duration of response and median time to progression in patients
treated with this regimen vs historical controls.
- Determine the immune response (humoral and/or cellular) of patients treated with this
regimen.
- Determine the safety of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive rituximab IV once weekly for 4 weeks. Beginning at least 8 weeks later,
patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine (Id-KLH) and
sargramostim (GM-CSF) subcutaneously once monthly for a total of 6 months in the absence of
disease progression or unacceptable toxicity.
Patients who achieve an objective response (complete response or partial response) or stable
disease may continue to receive Id-KLH and GM-CSF every other month for a total of 6 doses
and then every 3 months in the absence of disease progression.
Patients are followed every 6 months for at least 2 years.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed grade I or II follicular B-cell lymphoma
- Must meet one of the following criteria for relapsed/refractory disease:
- Relapsed or refractory after prior chemotherapy
- Relapsed after prior rituximab
- Rituximab may have been given as second-line therapy after an initial
response to chemotherapy or in combination with chemotherapy as initial
therapy
- No more than 2 prior treatment regimens
- Cyclophosphamide/doxorubicin/prednisone/vincristine (CHOP) and rituximab is
considered 1 prior treatment regimen
- CHOP followed by rituximab at initial relapse is considered 2 prior treatment
regimens
- Measurable disease after node biopsy
- At least 1 bidimensionally measurable lesion
- If only 1 measurable lesion remains after biopsy, it must be at least 2 cm in
each dimension
- Tumor accessible for biopsy or prior recent biopsy material available
- No known history of CNS lymphoma or meningeal lymphomatosis
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count at least 1,000/mm^3
- Lymphocyte count less than 5,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 2.0 mg/dL
- AST and ALT no greater than 2 times upper limit of normal
Renal
- Creatinine no greater than 1.5 mg/dL
Cardiovascular
- No congestive heart failure
Pulmonary
- No compromised pulmonary function that would preclude study participation, including
any of the following:
- Active asthma
- Chronic obstructive pulmonary disorder
- Pneumonitis
- Bronchiolitis obliterans
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- No active uncontrolled bacterial, viral, or fungal infection
- No other concurrent nonmalignant disease that would preclude study participation
- No other malignancy within the past 2 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No prior tumor-specific idiotype immunotherapy using the identical idiotype
Chemotherapy
- See Disease Characteristics
- More than 9 months since prior fludarabine
Endocrine therapy
- No concurrent high-dose steroid therapy
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 30 days since prior investigational drugs
- No concurrent immunosuppressive therapy
- No other concurrent anticancer therapy
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Omer N. Koc, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000299533
NCT ID:
NCT00060164
Start Date:
January 2003
Completion Date:
Related Keywords:
- Lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- Lymphoma
- Lymphoma, B-Cell
Name | Location |
|---|---|
| Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
