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Phase III, Randomized, Double Blind, Placebo-Controlled Trial of Favldand GM-CSF Versus Placebo and GM-CSF Following Rituximab in Subjects With Follicular B-Cell Non-Hodgkin's Lymphoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Phase III, Randomized, Double Blind, Placebo-Controlled Trial of Favldand GM-CSF Versus Placebo and GM-CSF Following Rituximab in Subjects With Follicular B-Cell Non-Hodgkin's Lymphoma


OBJECTIVES:

Primary

- Compare time to disease progression in patients with grade 1, 2, or 3 follicular B-cell
non-Hodgkin's lymphoma who respond (i.e., complete or partial response, or stable
disease) to treatment with rituximab and are then treated with sargramostim (GM-CSF)
with vs without autologous immunoglobulin idiotype-KLH conjugate vaccine.

Secondary

- Compare response rate improvement in patients treated with these regimens.

- Compare overall complete response rate in patients treated with these regimens.

- Compare duration of response in patients treated with these regimens.

- Determine the safety of these regimens in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to prior treatment (yes vs no) and response to rituximab during
study (complete response [CR] or partial response [PR] vs stable disease [SD]).

All patients receive rituximab IV once weekly for 4 weeks. Five weeks after the last dose of
rituximab, patients are assessed for response. Patients with progressive disease are removed
from the study and do not undergo randomization. Patients with a CR, PR, or SD are
randomized to 1 of 2 treatment arms.

- Arm I: Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine
subcutaneously (SC) on day 1. Patients also receive sargramostim (GM-CSF) SC on days
1-4.

- Arm II: Patients receive placebo SC on day 1. Patients also receive GM-CSF SC on days
1-4.

In both arms, treatment repeats monthly for 6 months in the absence of unacceptable toxicity
or clinically significant progressive disease. After the first 6 months, patients with a CR,
PR, or SD may continue to receive treatment (per treatment arm as above) every 2 months for
1 year (total of 6 doses) and then every 3 months thereafter in the absence of disease
progression.

Patients are followed every 3 months for 2 years and then every 6 months until disease
progression.

PROJECTED ACCRUAL: A total of 342 evaluable patients (171 per treatment arm) will be accrued
for this study within 18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL)

- Grade 1, 2, or 3

- Meets 1 of the following criteria for treatment with rituximab:

- Treatment naïve

- Relapsed or refractory disease after prior chemotherapy

- Relapsed after a prior documented response (i.e., complete or partial response)
to rituximab of at least 6 months duration

- Tumor accessible for biopsy OR existing biopsy material (taken within the past 6
months) suitable for vaccine preparation

- Measurable or evaluable disease after tumor tissue procurement for vaccine production

- No more than 2 prior treatment regimens for NHL

- Single regimens include any of the following:

- Maintenance rituximab

- Rituximab administered once weekly for 8 courses

- Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) plus
rituximab* NOTE: *CHOP followed by rituximab at time of relapse is
considered 2 treatment regimens

- No history of CNS lymphoma or meningeal lymphomatosis

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 75,000/mm^3 (unless related to bone marrow involvement by lymphoma)

- Hemoglobin ≥ 10g/dL

Hepatic

- Not specified

Renal

- Not specified

Cardiovascular

- No congestive heart failure

Pulmonary

- No compromised pulmonary function

Immunologic

- HIV negative

- No prior allergic response to GM-CSF

- No active bacterial, viral, or fungal infection

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No psychiatric disorder that would preclude study participation

- No other malignancy within the past 2 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No other serious nonmalignant disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- See Chemotherapy

- At least 4 weeks since prior immunotherapy

- No prior radiolabeled anti-lymphoma antibody (e.g., iodine I 131 tositumomab or
ibritumomab tiuxetan)

- No prior autologous or allogeneic stem cell transplantation

- No prior lymphoma-specific idiotype immunotherapy (e.g., Id vaccine)

- No prior investigational vaccine or immunotherapeutic containing keyhole limpet
hemocyanin (KLH)

Chemotherapy

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy

- More than 9 months since prior fludarabine

- More than 2 years since prior chemotherapy/rituximab combination therapy (e.g.,
CHOP/rituximab or cyclophosphamide, vincristine, and prednisone [CVP]/rituximab)

- No more than 6 total prior treatment courses with fludarabine

Endocrine therapy

- No concurrent steroids for allergic reaction to sargramostim (GM-CSF)

Radiotherapy

- See Biologic therapy

- At least 4 weeks since prior radiotherapy

Surgery

- Not specified

Other

- At least 4 weeks since prior experimental therapy

- No concurrent systemic immunosuppressive therapy

- No other concurrent anti-lymphoma therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Time to progression after 248 patients have progressed

Safety Issue:

No

Principal Investigator

John F. Bender, PharmD

Investigator Role:

Study Chair

Investigator Affiliation:

Favrille

Authority:

United States: Federal Government

Study ID:

CDR0000378046

NCT ID:

NCT00089115

Start Date:

July 2004

Completion Date:

Related Keywords:

  • Lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage I 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
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Rush University Medical CenterChicago, Illinois  60612-3824
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
North Shore University HospitalManhasset, New York  11030
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
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
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve UniversityCleveland, Ohio  44106
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
North Idaho Cancer CenterCoeur d'Alene, Idaho  83814
Stanford Cancer Center at Stanford University Medical CenterStanford, California  94305
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Fox Chase-Temple Cancer CenterPhiladelphia, Pennsylvania  19111-2442
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
Lombardi Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
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
Mid Dakota Clinic, P. C.Bismarck, North Dakota  58501
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
North Star Lodge Cancer Center at Yakima Valley Memorial HospitalYakima, Washington  98902
University of Florida Health Science Center - JacksonvilleJacksonville, Florida  32209
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
Sarah Cannon Cancer Center at Centennial Medical CenterNashville, Tennessee  37203
Greater Baltimore Medical CenterBaltimore, Maryland  21204
Beth Israel Medical Center - Philipps Ambulatory Care CenterNew York, New York  10003
Hoag Cancer Center at Hoag Memorial Hospital PresbyterianNewport Beach, California  92663
Tower Cancer Research FoundationBeverly Hills, California  90211
Rocky Mountain Cancer Centers - Denver MidtownDenver, Colorado  80218
Baylor University Medical Center - DallasDallas, Texas  75246
Roger Maris Cancer Center at MeritCare HospitalFargo, North Dakota  58122
Sharp Memorial Hospital Cancer CenterSan Diego, California  92123
Medical Oncology Hematology Consultants, P.A. at Helen F. Graham Cancer CenterNewark, Delaware  19713-2055
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 Network of South TexasSan Antonio, Texas  78229