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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

John F. Bender, PharmD

Investigator Role:

Study Chair

Investigator Affiliation:

Favrille

Authority:

Unspecified

Study ID:

CDR0000415573

NCT ID:

NCT00104819

Start Date:

September 2004

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Kaiser Permanente Medical Center - Vallejo Vallejo, California  94589
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City, Kansas  66160-7353
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Ochsner Cancer Institute at Ochsner Clinic Foundation New Orleans, Louisiana  70121
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Our Lady of Mercy Medical Center Comprehensive Cancer Center Bronx, New York  10466
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Los Angeles, California  90048-1865
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana  46202-5289
Lucille P. Markey Cancer Center at University of Kentucky Lexington, Kentucky  40536-0093
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset, New York  11030
Knight Cancer Institute at Oregon Health and Science University Portland, Oregon  97239-3098
Geisinger Cancer Institute at Geisinger Health Danville, Pennsylvania  17822-0001
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego San Diego, California  92120
University of Virginia Cancer Center Charlottesville, Virginia  22908
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus, Ohio  43210-1240
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington  98902
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa, Florida  33612
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224-1791
UAB Comprehensive Cancer Center Birmingham, Alabama  35294
Stanford Cancer Center Stanford, California  94305-5824
Greater Baltimore Medical Center Cancer Center Baltimore, Maryland  21204
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Sarah Cannon Cancer Center at Centennial Medical Center Nashville, Tennessee  37203
Rush Cancer Institute at Rush University Medical Center Chicago, Illinois  60612
Tower Cancer Research Foundation Beverly Hills, California  90211
Rocky Mountain Cancer Centers - Denver Midtown Denver, Colorado  80218
Kootenai Cancer Center - Coeur d'Alene Coeur d'Alene, Idaho  83814
Roger Maris Cancer Center at MeritCare Hospital Fargo, North Dakota  58122
Helen F. Graham Cancer Center at Christiana Hospital Newark, Delaware  19718
Sharp Memorial Hospital Cancer Center San Diego, California  92123
Center for Hematology-Oncology - Boca Raton Boca Raton, Florida  33486
New Mexico Cancer Center Albuquerque, New Mexico  87109
Kaiser Permanente Medical Office - Interstate Medical Office Central Portland, Oregon  97227
Cancer Care Centers of South Texas - Medical Center San Antonio, Texas  78229