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Vaccine Therapy and GM-CSF in Treating Patients With Progressive Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
autologous immunoglobulin idiotype-KLH conjugate vaccine
sargramostim
Sponsored by
Favrille
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

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL) Grade 1, 2, or 3 Progressive disease AND did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™) while enrolled on protocol FAV-ID-06 Meets 1 of the following criteria: Received salvage therapy after completion of protocol FAV-ID-06 At least 4 weeks, but no more than 4 months, since prior salvage therapy Did not receive salvage therapy after completion of protocol FAV-ID-06 At least 4 weeks, but no more than 4 months, since completion of prior treatment on protocol FAV-ID-06 No history of CNS lymphoma OR meningeal lymphomatosis PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Cardiovascular No history of congestive heart failure Pulmonary No history of compromised pulmonary function Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No active bacterial, viral, or fungal infection No psychiatric disorder No other serious nonmalignant disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics No prior allogeneic transplantation* No prior rituximab regimen* other than that administered on protocol FAV-ID-06 (rituximab 375 mg/m^2 IV weekly for 4 weeks) Chemotherapy No prior purine analogues* (e.g., fludarabine or cladribine) Endocrine therapy No prior or concurrent steroids (e.g., steroid doses in excess of daily replacement) Radiotherapy Not specified Surgery Not specified Other Recovered from prior salvage therapy No prior or concurrent immunosuppressive therapy No prior investigational agents* No other concurrent antilymphoma therapy NOTE: *As salvage therapy administered between completion of protocol FAV-ID-06 and enrollment onto this study

Sites / Locations

  • UAB Comprehensive Cancer Center
  • Tower Cancer Research Foundation
  • Rebecca and John Moores UCSD Cancer Center
  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
  • Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
  • Sharp Memorial Hospital Cancer Center
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • Stanford Cancer Center
  • Kaiser Permanente Medical Center - Vallejo
  • Rocky Mountain Cancer Centers - Denver Midtown
  • Helen F. Graham Cancer Center at Christiana Hospital
  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
  • Center for Hematology-Oncology - Boca Raton
  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
  • Kootenai Cancer Center - Coeur d'Alene
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • Rush Cancer Institute at Rush University Medical Center
  • Indiana University Melvin and Bren Simon Cancer Center
  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
  • Lucille P. Markey Cancer Center at University of Kentucky
  • Ochsner Cancer Institute at Ochsner Clinic Foundation
  • Greater Baltimore Medical Center Cancer Center
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • Josephine Ford Cancer Center at Henry Ford Hospital
  • Mayo Clinic Cancer Center
  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
  • Montana Cancer Specialists at Montana Cancer Center
  • New Mexico Cancer Center
  • Our Lady of Mercy Medical Center Comprehensive Cancer Center
  • Don Monti Comprehensive Cancer Center at North Shore University Hospital
  • Memorial Sloan-Kettering Cancer Center
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • Wake Forest University Comprehensive Cancer Center
  • Mid Dakota Clinic, PC
  • Roger Maris Cancer Center at MeritCare Hospital
  • Charles M. Barrett Cancer Center at University Hospital
  • Case Comprehensive Cancer Center
  • Cleveland Clinic Taussig Cancer Center
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
  • Providence Cancer Center at Providence Portland Medical Center
  • Kaiser Permanente Medical Office - Interstate Medical Office Central
  • Knight Cancer Institute at Oregon Health and Science University
  • Geisinger Cancer Institute at Geisinger Health
  • Fox Chase Cancer Center - Philadelphia
  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
  • Sarah Cannon Cancer Center at Centennial Medical Center
  • Cancer Care Centers of South Texas - Medical Center
  • University of Virginia Cancer Center
  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ provided to patients who did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ during participation on study Favld-06

Secondary Outcome Measures

Response rate by modified Cheson Criteria
Duration of response by modified Cheson Criteria
Time to progression
Response rate improvement

Full Information

First Posted
March 3, 2005
Last Updated
August 1, 2013
Sponsor
Favrille
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00104819
Brief Title
Vaccine Therapy and GM-CSF in Treating Patients With Progressive Non-Hodgkin's Lymphoma
Official Title
Phase II Trial of FavId™ (Patient-Specific Idiotype/KLH) and GM-CSF in Subjects Who Demonstrated Progressive Disease and Did Not Receive FavId on Study FavId-06
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Terminated
Why Stopped
Withdrawn as company has shut down and filed for bankruptcy
Study Start Date
September 2004 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Favrille
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Vaccines made from a person's cancer cells may make the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may stimulate the immune system in different ways and stop cancer cells from growing. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with progressive B-cell non-Hodgkin's lymphoma.
Detailed Description
OBJECTIVES: Primary Provide treatment with autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ and sargramostim (GM-CSF) to patients with progressive grade 1, 2, or 3 follicular B-cell non-Hodgkin's lymphoma who did not receive FavId™ while enrolled on protocol FAV-ID-06. Secondary Determine the response rate and duration of response in patients treated with this regimen. Determine the response rate and response rate improvement after best response to prior salvage therapy in patients treated with this regimen. Determine the time to progression in patients treated with this regimen. Determine the safety of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups according to timing of disease progression while enrolled on protocol FAV-ID-06 (disease progression after prior rituximab AND never randomized vs disease progression after randomization to placebo arm). Patients receive autologous immunoglobulin idiotype-KLH vaccine subcutaneously (SC) on day 1. Patients also receive sargramostim (GM-CSF) SC on days 1-4. Treatment repeats monthly for 6 months in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional treatment as above every 2 months for 1 year (6 treatments) and every 3 months until disease progression. After completion of study treatment, patients are followed for 30 days or until the start of subsequent treatment. PROJECTED ACCRUAL: Approximately 238 patients (67 in group I and 171 in group II) 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

7. Study Design

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

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
Autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ provided to patients who did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ during participation on study Favld-06
Secondary Outcome Measure Information:
Title
Response rate by modified Cheson Criteria
Title
Duration of response by modified Cheson Criteria
Title
Time to progression
Title
Response rate improvement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL) Grade 1, 2, or 3 Progressive disease AND did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™) while enrolled on protocol FAV-ID-06 Meets 1 of the following criteria: Received salvage therapy after completion of protocol FAV-ID-06 At least 4 weeks, but no more than 4 months, since prior salvage therapy Did not receive salvage therapy after completion of protocol FAV-ID-06 At least 4 weeks, but no more than 4 months, since completion of prior treatment on protocol FAV-ID-06 No history of CNS lymphoma OR meningeal lymphomatosis PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Cardiovascular No history of congestive heart failure Pulmonary No history of compromised pulmonary function Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No active bacterial, viral, or fungal infection No psychiatric disorder No other serious nonmalignant disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics No prior allogeneic transplantation* No prior rituximab regimen* other than that administered on protocol FAV-ID-06 (rituximab 375 mg/m^2 IV weekly for 4 weeks) Chemotherapy No prior purine analogues* (e.g., fludarabine or cladribine) Endocrine therapy No prior or concurrent steroids (e.g., steroid doses in excess of daily replacement) Radiotherapy Not specified Surgery Not specified Other Recovered from prior salvage therapy No prior or concurrent immunosuppressive therapy No prior investigational agents* No other concurrent antilymphoma therapy NOTE: *As salvage therapy administered between completion of protocol FAV-ID-06 and enrollment onto this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John F. Bender, PharmD
Organizational Affiliation
Favrille
Official's Role
Study Chair
Facility Information:
Facility Name
UAB Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Tower Cancer Research Foundation
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Rebecca and John Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0960
Country
United States
Facility Name
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Sharp Memorial Hospital Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0324
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5824
Country
United States
Facility Name
Kaiser Permanente Medical Center - Vallejo
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Denver Midtown
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Helen F. Graham Cancer Center at Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Center for Hematology-Oncology - Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Kootenai Cancer Center - Coeur d'Alene
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
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 Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7357
Country
United States
Facility Name
Lucille P. Markey Cancer Center at University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0093
Country
United States
Facility Name
Ochsner Cancer Institute at Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Greater Baltimore Medical Center Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
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
Josephine Ford Cancer Center at Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2608
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Montana Cancer Specialists at Montana Cancer Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807-7877
Country
United States
Facility Name
New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Our Lady of Mercy Medical Center Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466-2604
Country
United States
Facility Name
Don Monti Comprehensive Cancer Center at North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States
Facility Name
Mid Dakota Clinic, PC
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Roger Maris Cancer Center at MeritCare Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Charles M. Barrett Cancer Center at University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Providence Cancer Center at Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Kaiser Permanente Medical Office - Interstate Medical Office Central
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Knight Cancer Institute at Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Geisinger Cancer Institute at Geisinger Health
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-0001
Country
United States
Facility Name
Fox Chase Cancer Center - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Sarah Cannon Cancer Center at Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Cancer Care Centers of South Texas - Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vaccine Therapy and GM-CSF in Treating Patients With Progressive Non-Hodgkin's Lymphoma

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