Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Rituximab, Autologous Vaccine Therapy, and Sargramostim in Treating Patients With Recurrent or Refractory Follicular B-Cell Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	CWRU-FVID-1402 FAV-ID-04, NCT00060164

Objectives

1. 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.
2. Compare the median duration of response and median time to progression in patients treated with this regimen vs historical controls.
3. Determine the immune response (humoral and/or cellular) of patients treated with this regimen.
4. Determine the safety of this regimen in these patients.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count at least 1,000/mm³
• Lymphocyte count less than 5,000/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 44 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Ireland Cancer Center at University Hospitals/Case Medical Center

Omer Koc, MD, Protocol chair(Contact information may not be current)		Ph: 216-844-8797

Registry Information
Official Title		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
Trial Start Date		2003-01-16
Registered in ClinicalTrials.gov		NCT00060164
Date Submitted to PDQ		2003-03-19
Information Last Verified		2004-04-13
NCI Grant/Contract Number		P30-CA43703

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