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

This study is ongoing, but not recruiting participants.

Sponsored by: University of Nebraska
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004198
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: autologous tumor cell vaccine
Drug: keyhole limpet hemocyanin
Drug: sargramostim
Phase II

MedlinePlus related topics:   Cancer    Lymphoma   

Drug Information available for:   Sargramostim    Granulocyte-macrophage colony-stimulating factor   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   June 1999

Detailed Description:

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

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004198

Locations
United States, Nebraska
University of Nebraska Medical Center    
      Omaha, Nebraska, United States, 68198-3330

Sponsors and Collaborators
University of Nebraska

Investigators
Study Chair:     Julie M. Vose, MD     University of Nebraska    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067441, UNMC-196-99, GENITOPE-9901
First Received:   January 21, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00004198
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III grade 1 follicular lymphoma  
stage III grade 2 follicular lymphoma  
stage IV grade 1 follicular lymphoma  
stage IV grade 2 follicular lymphoma  

Study placed in the following topic categories:
Lymphoma, B-Cell
Lymphatic Diseases
Immunoproliferative Disorders
Immunoglobulin Idiotypes
B-cell lymphomas
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Keyhole-limpet hemocyanin
Lymphoma
Follicular lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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