Clinical Trial: Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma

This study is no longer recruiting patients.

Sponsored by: Genitope
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vaccines may make the body build an immune response to kill cancer cells. It is not yet known which regimen of chemotherapy combined with vaccine therapy is more effective for non-Hodgkin's lymphoma.

PURPOSE: Randomizedphase III trial to determine the effectiveness of combination chemotherapy followed by vaccine therapy plus sargramostim in treating patients who have stage III or stage IV non-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
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
 Drug: autologous immunoglobulin idiotype-KLH conjugate vaccine
 Drug: cyclophosphamide
 Drug: keyhole limpet hemocyanin
 Drug: prednisone
 Drug: sargramostim
 Drug: vincristine
 Procedure: biological response modifier therapy
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: non-specific immune-modulator therapy
 Procedure: tumor cell derivative vaccine
 Procedure: vaccine therapy
Phase III

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lymphatic Diseases;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Cyclophosphamide, Prednisone, and Vincristine Followed By Immunotherapy With Keyhole Limpet Hemocyanin With or Without Recombinant Autologous Tumor-Derived Immunoglobulin Idiotype and Adjuvant Sargramostim (GM-CSF) in Patients With Stage III or IV Follicular B-Cell Non-Hodgkin's Lymphoma

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.

Patients receive cyclophosphamide IV over 30-40 minutes and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days for 8 courses.

At 6 months after completion of chemotherapy, patients maintaining partial response (PR), complete response (CR), or unconfirmed complete response (CRU) receive immunotherapy. Patients are stratified according to participating center and baseline disease status (PR vs CR/CRU). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive autologous tumor-derived immunoglobulin idiotype conjugated to keyhole limpet hemocyanin (KLH) subcutaneously (SC) on day 1 and adjuvant sargramostim (GM-CSF) SC on days 1-4 of weeks 0, 4, 8, 12, 16, 20, and 24.
  • Arm II: Patients receive KLH alone SC on day 1 and GM-CSF SC on days 1-4 of weeks 0, 4, 8, 12, 16, 20, and 24. Quality of life is assessed prior to first immunization, at 2-8 weeks after completion of immunizations, and then every 6 months for 30 months.

Patients are followed every 3 months for 1 year and then every 6 months thereafter. Patients also enroll in a long-term follow-up study for an additional 5 years.

PROJECTED ACCRUAL: A total of 360 patients (240 in arm I and 120 in arm II) will be accrued from the 480 patients biopsied for this study within 15-18 months.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage III or IV follicular B-cell non-Hodgkin's lymphoma
  • At least 1 bidimensionally measurable lesion by radiography, in addition to lesion removed for biopsy
  • No clinical evidence of CNS involvement

PATIENT CHARACTERISTICS: Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative

Renal:

  • Creatinine less than 1.5 times ULN

Other:

  • No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
  • No history of autoimmune disease
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

Chemotherapy:

Endocrine therapy:

  • No prior corticosteroids for lymphoma
  • At least 12 months since prior corticosteroids or immunosuppressants for other conditions
  • Prior transient corticosteroids (prior to CT imaging) or optical solutions allowed

Radiotherapy:

Surgery:

  • See Disease Characteristics

Other:


Location Information


California
      California Cancer Care, Inc., Greenbrae,  California,  94904,  United States

      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

      Stanford Cancer Center at Stanford University Medical Center, Stanford,  California,  94305-5151,  United States

      SuperGen, Incorporated, Dublin,  California,  94568,  United States

Colorado
      Rocky Mountain Cancer Centers - Midtown, Denver,  Colorado,  80218,  United States

Florida
      Shands Cancer Center at the University of Florida Health Science Center, Gainesville,  Florida,  32610-0277,  United States

Idaho
      Mountain States Tumor Institute - Boise, Boise,  Idaho,  83712,  United States

Illinois
      Rush Cancer Institute at Rush University Medical Center, Chicago,  Illinois,  60612,  United States

Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202,  United States

Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1009,  United States

Maryland
      Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore,  Maryland,  21201,  United States

      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231,  United States

Michigan
      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0942,  United States

      Veterans Affairs Medical Center - Ann Arbor, Ann Arbor,  Michigan,  48105-2399,  United States

Missouri
      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States

Nebraska
      UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha,  Nebraska,  68198-7680,  United States

New Jersey
      Cancer Center at Hackensack University Medical Center, Hackensack,  New Jersey,  07601,  United States

New York
      New York Weill Cornell Cancer Center at Cornell University, New York,  New York,  10021,  United States

Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210-1240,  United States

Oregon
      Cancer Institute at Oregon Health and Science University, Portland,  Oregon,  97201-3098,  United States

Tennessee
      Sarah Cannon Cancer Center at Centennial Medical Center, Nashville,  Tennessee,  37203,  United States

Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada

Canada, British Columbia
      British Columbia Cancer Agency, Vancouver,  British Columbia,  V5Z 4E6,  Canada

Canada, Ontario
      Toronto Sunnybrook Regional Cancer Centre, Toronto,  Ontario,  M4N 3M5,  Canada

Study chairs or principal investigators

Lori Kunkel, MD,  Study Chair,  Genitope   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068673; GENITOPE-G2000-03; CUMC-0101-142; UCLA-0010061
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  June 6, 2001
ClinicalTrials.gov Identifier:  NCT00017290
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources