Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Collaborators:
Genitope Corporation
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00004198
First received: January 21, 2000
Last updated: June 23, 2010
Last verified: June 2010

January 21, 2000
June 23, 2010
June 1999
January 2002   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00004198 on ClinicalTrials.gov Archive Site
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Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma
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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Vaccines may make the body build an immune response to kill tumor cells. Sargramostim may stimulate a person's immune system and help to kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus sargramostim following chemotherapy in treating patients who have stage III or stage IV non-Hodgkin's 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.

PROJECTED ACCRUAL: Not specified

Interventional
Phase 2
Primary Purpose: Treatment
Lymphoma
  • Biological: keyhole limpet hemocyanin
  • Biological: sargramostim
  • Biological: tumor cell-based vaccine therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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November 2003
January 2002   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004198
196-99, P30CA036727, UNMC-196-99, GENITOPE-9901
No
Julie M. Vose, Principal Investigator, University of Nebraska Medical Cente
University of Nebraska
  • National Cancer Institute (NCI)
  • Genitope Corporation
Study Chair: Julie M. Vose, MD University of Nebraska
University of Nebraska
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP