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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

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 CenterCleveland, Ohio  44106-5065