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A Phase III Trial To Evaluate The Safety And Efficacy Of Specific Immunotherapy, Recombinant Idiotype Conjugated To KLH With GM-CSF, Compared To Non-Specific Immunotherapy, KLH With GM-CSF, In Patients With Follicular Non-Hodgkin's Lymphoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

A Phase III Trial To Evaluate The Safety And Efficacy Of Specific Immunotherapy, Recombinant Idiotype Conjugated To KLH With GM-CSF, Compared To Non-Specific Immunotherapy, KLH With GM-CSF, In Patients With Follicular Non-Hodgkin's Lymphoma


OBJECTIVES:

- Compare the time to tumor progression in patients with stage III or IV follicular
B-cell non-Hodgkin's lymphoma treated with cyclophosphamide, prednisone, and
vincristine followed by immunotherapy with keyhole limpet hemocyanin with or without
autologous tumor-derived immunoglobulin idiotype and adjuvant sargramostim (GM-CSF).

- Compare the efficacy of these immunotherapy regimens in terms of converting patients
with partial response or unconfirmed complete response to clinical complete response.

- Compare the safety and toxic effects of these immunotherapy regimens in this patient
population.

- Compare the time to treatment failure and survival of patients treated with these
regimens.

- Correlate the induction of idiotype-specific immune response with clinical benefits of
achieving molecular remission in these patients.

- Compare the quality of life of patients treated with these regimens.

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.

Inclusion 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:

- No prior antibody therapy for lymphoma

Chemotherapy:

- No prior cytotoxic therapy for lymphoma

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:

- Prior radiotherapy for lymphoma (no more than 2 sites of limited disease) allowed

Surgery:

- See Disease Characteristics

Other:

- No concurrent participation in other therapeutic clinical trial

Type of Study:

Interventional

Study Design:

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

Principal Investigator

David Hinds

Investigator Role:

Study Chair

Investigator Affiliation:

Genitope Corporation

Authority:

United States: Federal Government

Study ID:

CDR0000068673

NCT ID:

NCT00017290

Start Date:

November 2000

Completion Date:

Related Keywords:

  • 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
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Washington University School of MedicineSaint Louis, Missouri  63110
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
California Cancer Care, Inc.Greenbrae, California  94904-2007
Stanford Cancer Center at Stanford University Medical CenterStanford, California  94305
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Shands Cancer Center at the University of Florida Health Science CenterGainesville, Florida  32610-0296
Mountain States Tumor Institute - BoiseBoise, Idaho  83712
Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
Sarah Cannon Cancer Center at Centennial Medical CenterNashville, Tennessee  37203
Rush Cancer Institute at Rush University Medical CenterChicago, Illinois  60612
SuperGen, IncorporatedDublin, California  94568
Rocky Mountain Cancer Centers - MidtownDenver, Colorado  80218