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Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
autologous immunoglobulin idiotype-KLH conjugate vaccine
sargramostim
Sponsored by
Genitope Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Cancer Center at Stanford University Medical Center
  • Rush Cancer Institute at Rush University Medical Center
  • Indiana University Cancer Center
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • Siteman Cancer Center at Barnes-Jewish Hospital
  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
  • New York Weill Cornell Cancer Center at Cornell University
  • Cancer Institute at Oregon Health and Science University
  • Cross Cancer Institute at University of Alberta
  • Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Immune response rates in patients who received at least 4 immunizations by anti-idiotype antibody and anti-KLH antibody assays during every other immunization, last immunization, 2 and 8 weeks post immunization, and then quarterly for 1 year
Clinical response in patients who received at least 1 immunization in groups I and II by modified Cheson criteria post-immunization and then every 6 months for 1 year
Safety at the start of immunization, every 8 weeks during immunization, 2 and 8 weeks post immunization, and then quarterly for 1 year

Full Information

First Posted
November 4, 2003
Last Updated
December 18, 2013
Sponsor
Genitope Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00071955
Brief Title
Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Genitope Corporation

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. PURPOSE: Phase II trial to study the effectiveness of rituximab followed by vaccine therapy and sargramostim in treating patients who have refractory or progressive non-Hodgkin's lymphoma.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
autologous immunoglobulin idiotype-KLH conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
sargramostim
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Immune response rates in patients who received at least 4 immunizations by anti-idiotype antibody and anti-KLH antibody assays during every other immunization, last immunization, 2 and 8 weeks post immunization, and then quarterly for 1 year
Title
Clinical response in patients who received at least 1 immunization in groups I and II by modified Cheson criteria post-immunization and then every 6 months for 1 year
Title
Safety at the start of immunization, every 8 weeks during immunization, 2 and 8 weeks post immunization, and then quarterly for 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Mayo, PharmD
Organizational Affiliation
Genitope Corporation
Official's Role
Study Chair
Facility Information:
Facility Name
Stanford Cancer Center at Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5151
Country
United States
Facility Name
Rush Cancer Institute at Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
New York Weill Cornell Cancer Center at Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Cancer Institute at Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States
Facility Name
Cross Cancer Institute at University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19125383
Citation
Timmerman JM, Vose JM, Czerwinski DK, Weng WK, Ingolia D, Mayo M, Denney DW, Levy R. Tumor-specific recombinant idiotype immunisation after chemotherapy as initial treatment for follicular non-Hodgkin lymphoma. Leuk Lymphoma. 2009 Jan;50(1):37-46. doi: 10.1080/10428190802563355.
Results Reference
result

Learn more about this trial

Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma

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