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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 Indolent B Cell Lymphoma

Phase 2
18 Years
Not Enrolling

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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 Indolent 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 stage III or IV indolent 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 oral cyclophosphamide,
vincristine, and prednisone (CVP). 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 10 courses. Patients not achieving adequate response receive up to 6
courses of alternate chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine,
and prednisone. At 3 months or up to 1 year 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)
at 2 sites immediately followed by sargramostim (GM-CSF) SQ on day 1. Patients receive
GM-CSF alone on days 2-4. Vaccination repeats every 4 weeks for 4 doses, followed 12 weeks
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.


Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV, indolent non-Hodgkin's
lymphoma Follicular small cleaved cell Follicular mixed small cleaved and large cell with
less than 50% large cells No intermediate, high grade, or other non-Hodgkin's lymphomas
(e.g., mantle cell, monocytoid B cell, marginal zone, small lymphocytic, chronic
lymphocytic leukemia, or follicular large cell) Tumor sample safely accessible by biopsy,
needle aspiration, or phlebotomy Must have adequate circulating lymphoma cells No CNS
metastasis A new classification scheme for adult non-Hodgkin's lymphoma has been adopted
by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former
terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol
uses the former terminology.

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 mg/dL
SGOT/SGPT less than 2 times normal Renal: Creatinine less than 2 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

PRIOR CONCURRENT THERAPY: Biologic: No prior biologic therapy for lymphoma Chemotherapy:
No prior cytotoxic therapy for lymphoma Endocrine: 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 5 mg of daily prednisone or
equivalent Radiotherapy: No prior radiotherapy for lymphoma Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Julie M. Vose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Nebraska


United States: Federal Government

Study ID:




Start Date:

June 1999

Completion Date:

November 2003

Related Keywords:

  • Lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin



University of Nebraska Medical Center Omaha, Nebraska  68198-3330