A Phase II Study to Evaluate Safety and Efficacy of Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH and GM-CSF Following the Anti-CD20 Antibody, Rituximab, in Previously Treated Patients With Follicular Non-Hodgkin's Lymphoma
18 Years
N/A
Both
Lymphoma
Trial Information
A Phase II Study to Evaluate Safety and Efficacy of Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH and GM-CSF Following the Anti-CD20 Antibody, Rituximab, in Previously Treated Patients With Follicular Non-Hodgkin's Lymphoma
OBJECTIVES:
- Determine progression-free survival in patients with refractory or progressive
follicular non-Hodgkin's lymphoma treated with immediate or delayed autologous
immunoglobulin idiotype-KLH conjugate vaccine and sargramostim after rituximab (groups
I and II).
- Determine the immune response rate in patients treated with these regimens (groups I,
II, and III).
- Determine the safety and toxicity of these regimens in these patients (groups I, II,
and III).
OUTLINE: This is an open-label, multicenter study for patients previously registered on and
confirmed ineligible for randomization in protocol Genitope-G2000-03.
Patients receive rituximab IV weekly for 4 weeks.
- Group I: The first 30 patients to achieve and maintain a partial response (PR) or
better receive autologous immunoglobulin idiotype-KLH conjugate vaccine subcutaneously
(SC) on day 1 and sargramostim SC on days 1-4 beginning 26 weeks after the last dose of
rituximab. Treatment repeats every 2 weeks for 14 weeks (8 immunizations).
- Group II: All subsequent patients who achieve a PR or better receive autologous
immunoglobulin idiotype-KLH conjugate vaccine and sargramostim SC as in group I
beginning 13 weeks after the last dose of rituximab.
- Group III: Patients who are not eligible for group I or II and, in the investigator's
opinion, are suitable candidates for immunization with autologous immunoglobulin
idiotype-KLH conjugate vaccine and sargramostim SC receive the same treatment as groups
I and II, beginning no more than 1 year after the last (fourth) dose of rituximab.
In all groups, treatment continues in the absence of unacceptable toxicity or emergence of
an illness that may interfere with study assessments.
Patients are followed for initial response 8 weeks after completion of immunizations and
then every 12 weeks for an additional year. Thereafter, all immunized patients will be
followed every 6 months until receipt of first subsequent anti-lymphoma therapy.
PROJECTED ACCRUAL: Up to 120 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed follicular center cell non-Hodgkin's lymphoma
- Stage III or IV disease at time of entry on Genitope-G2000-03
- At least 1 bidimensionally measurable lesion (1.5 cm X 1.5 cm) by radiography
- Previously registered on and confirmed to be ineligible for randomization on
Genitope-G2000-03 by failing to achieve or maintain a complete or partial response
after chemotherapy by CT scans of the chest, abdomen, and pelvis (and neck if there
was palpable disease)
- Completed all 8 courses of chemotherapy (cyclophosphamide, vincristine, and
prednisone [CVP]) per Genitope-G2000-03
- No intervening therapy for lymphoma (i.e., antibody, corticosteroids, or cytotoxic)
between CVP and study entry
- No evidence of transformation (e.g., rapid tumor growth or increasing lactic
dehydrogenase)
- No CNS involvement
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after the
last immunization series
- HIV negative
- No history of autoimmune disease or conditions requiring treatment with
immunosuppressive agents, including corticosteroids
- No other malignancy within the past 2 years except non-basal cell skin cancer or
carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- See Disease Characteristics
- At least 6 months since prior corticosteroids, including topical administration for
any concurrent disease
- No concurrent chronic (more than twice monthly) corticosteroids (including topical or
inhaled)
- Transient use (prior to CT scan) or optical solutions allowed
Radiotherapy
- Prior radiotherapy to no more than 2 sites more than 13 weeks before rituximab is
allowed
Surgery
- Not specified
Other
- No concurrent participation in other therapeutic clinical trials
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival (PFS) in groups I and II and median PFS by Kaplan-Meier curves quarterly for 1 year and then twice a year after study completion
Safety Issue:
No
Principal Investigator
Martha Mayo, PharmD
Investigator Role:
Study Chair
Investigator Affiliation:
Genitope Corporation
Authority:
United States: Federal Government
Study ID:
CDR0000269810
NCT ID:
NCT00071955
Start Date:
March 2003
Completion Date:
Related Keywords:
- Lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Cancer Institute at Oregon Health and Science University | Portland, Oregon 97201-3098 |
| Stanford Cancer Center at Stanford University Medical Center | Stanford, California 94305 |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
| New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
| Rush Cancer Institute at Rush University Medical Center | Chicago, Illinois 60612 |
