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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 CenterNew York, New York  10021
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Kaiser Permanente Medical Center - VallejoVallejo, California  94589
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Our Lady of Mercy Medical Center Comprehensive Cancer CenterBronx, New York  10466
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Knight Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97239-3098
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San DiegoSan Diego, California  92120
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
North Star Lodge Cancer Center at Yakima Valley Memorial HospitalYakima, Washington  98902
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224-1791
UAB Comprehensive Cancer CenterBirmingham, Alabama  35294
Stanford Cancer CenterStanford, California  94305-5824
Greater Baltimore Medical Center Cancer CenterBaltimore, Maryland  21204
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Sarah Cannon Cancer Center at Centennial Medical CenterNashville, Tennessee  37203
Rush Cancer Institute at Rush University Medical CenterChicago, Illinois  60612
Tower Cancer Research FoundationBeverly Hills, California  90211
Rocky Mountain Cancer Centers - Denver MidtownDenver, Colorado  80218
Kootenai Cancer Center - Coeur d'AleneCoeur d'Alene, Idaho  83814
Roger Maris Cancer Center at MeritCare HospitalFargo, North Dakota  58122
Helen F. Graham Cancer Center at Christiana HospitalNewark, Delaware  19718
Sharp Memorial Hospital Cancer CenterSan Diego, California  92123
Center for Hematology-Oncology - Boca RatonBoca Raton, Florida  33486
New Mexico Cancer CenterAlbuquerque, New Mexico  87109
Kaiser Permanente Medical Office - Interstate Medical Office CentralPortland, Oregon  97227
Cancer Care Centers of South Texas - Medical CenterSan Antonio, Texas  78229