Know Cancer

or
forgot password

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


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

Thank you

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 CenterIndianapolis, Indiana  46202-5265
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Stanford Cancer Center at Stanford University Medical CenterStanford, California  94305
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Rush Cancer Institute at Rush University Medical CenterChicago, Illinois  60612