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A Phase II Trial to Evaluate the Rate of Immune Response Using Idiotype Immunotherapies Produced by Molecular Biological Means for Treatment of Aggressive B Cell Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

A Phase II Trial to Evaluate the Rate of Immune Response Using Idiotype Immunotherapies Produced by Molecular Biological Means for Treatment of Aggressive B Cell Lymphoma


OBJECTIVES: I. Determine the ability of recombinant idiotype immunotherapy to stimulate a
specific immune response against the B cell idiotype of the malignant clone that constitutes
the tumor in patients with previously untreated aggressive non-Hodgkin's lymphoma. II.
Determine the safety and toxicity of this treatment regimen using Genitope Corporation's
molecular rescue technology in this patient population.

OUTLINE: Patients receive induction chemotherapy consisting of cyclophosphamide,
doxorubicin, vincristine, and prednisone (CHOP) or cyclophosphamide, mitoxantrone,
vincristine, and prednisone (CNOP). Treatment repeats every 3 weeks until the maximal
clinical response is achieved followed by 2 additional courses of consolidation therapy for
up to a maximum of 6 courses. At 2-6 months following completion of chemotherapy, patients
achieving adequate disease response receive vaccination consisting of recombinant tumor
derived immunoglobulin idiotype with keyhole limpet hemocyanin conjugate subcutaneously (SQ)
followed by sargramostim (GM-CSF) SQ, each at 2 separate sites on day 1. Patients receive
GM-CSF alone on days 2-4. Vaccination repeats every 4 weeks for 4 doses, followed 3 months
later by the fifth and final dose. Patients are followed every 3 months for 2 years, every 6
months for 2 years, and then annually thereafter until disease progression.

PROJECTED ACCRUAL: Not specified

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed aggressive non-Hodgkin's lymphoma
Diffuse mixed cell Diffuse large cell Immunoblastic Follicular large cell with more than
50% large cells Mantle cell Non-age adjusted International Prognostic Index 2-4 Tumor
sample safely accessible by biopsy, needle aspiration, or phlebotomy Must have adequate
circulating lymphoma cells No CNS metastasis

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 80-100% Life
expectancy: Not specified Hematopoietic: WBC greater than 2,500/mm3 Platelet count greater
than 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 2.0 mg/dL
SGOT/SGPT less than 2 times normal Renal: Creatinine less than 2.0 mg/dL Other: No other
illness or condition, including innate or pharmacologic immunosuppression, that would
preclude study No other malignancy within the last 5 years except adequately treated basal
or squamous cell skin cancer or carcinoma in situ of the cervix HIV negative Not pregnant
or nursing Negative pregnancy test Fertile patients must use effective contraception
during and for 6 months after the study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for lymphoma
Chemotherapy: No prior cytotoxic chemotherapy for lymphoma Endocrine therapy: No prior
steroids for lymphoma At least 2 months since prior nonphysiologic doses of prednisone of
greater than 20 mg or equivalent No concurrent maintenance steroids or greater than 5mg of
daily prednisone or equivalent Radiotherapy: No prior radiotherapy for lymphoma Surgery:
Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Julie M. Vose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Nebraska

Authority:

United States: Federal Government

Study ID:

197-99

NCT ID:

NCT00004197

Start Date:

June 1999

Completion Date:

November 2003

Related Keywords:

  • Lymphoma
  • stage I grade 3 follicular lymphoma
  • stage I adult diffuse mixed cell lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage I adult immunoblastic large cell lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage I mantle cell lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • contiguous stage II mantle cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location
Stanford University Medical Center Stanford, California  94305-5408
University of Nebraska Medical Center Omaha, Nebraska  68198-3330