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Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III, Stage IV, or Recurrent Follicular Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00020462
Recruitment Status : Completed
First Posted : August 7, 2003
Last Update Posted : April 30, 2015
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. Combining vaccine therapy with interleukin-2 may be a more effective treatment for follicular lymphoma .

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus interleukin-2 in treating patients who have stage III, stage IV, or recurrent follicular lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: aldesleukin Biological: autologous tumor cell vaccine Phase 1

Detailed Description:


  • Assess the safety of immunotherapy with autologous tumor cell vaccine and interleukin-2 in patients with stage III, IV, or recurrent follicular lymphoma.
  • Determine the clinical response of patients treated with this regimen.
  • Assess the immune response of patients treated with this vaccine.

OUTLINE: This is a multicenter study. Patients are stratified according to prior therapy (no prior biologic therapy or chemotherapy for lymphoma vs prior prednisone, doxorubicin, cyclophosphamide, and etoposide (PACE) chemotherapy). Patients without prior therapy are further stratified according to accessibility of lymph nodes (easily accessible (stratum Ia) vs not easily accessible (stratum Ib)).

All patients undergo lymph node biopsy to obtain tissue for vaccine manufacture. Treatment begins approximately 1 month after biopsy.

  • Stratum Ia: Patients receive autologous tumor cell vaccine and interleukin-2 (IL-2) intranodally and subcutaneously (SC) on day 1.
  • Stratum Ib and stratum II: Patients receive autologous tumor cell vaccine and IL-2 SC on day 1.

Treatment in each stratum continues every 4 weeks for a maximum of 5 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 and 4 months, every 3 months for 1 year, and every 6 months thereafter until relapse or progression of disease.

PROJECTED ACCRUAL: A total of 20 patients (10 per stratum) will be accrued for this study within 1.5-2 years.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Active Specific Immunotherapy for Follicular Lymphomas With Liposomes Containing Tumor-Derived Antigen and IL-2
Study Start Date : February 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Aldesleukin

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven follicular center cell lymphoma with surface immunoglobulin (Ig) M, G, or A phenotype

    • Grade I (follicular small cleaved cell)
    • Grade II (follicular mixed small and large cell)
    • Grade III (follicular large cell)
  • Stage III, IV, or recurrent disease
  • Previously untreated with chemotherapy or monoclonal antibody therapy OR
  • Recurrent, residual disease or progressive disease after prior prednisone, doxorubicin, cyclophosphamide, and etoposide (PACE) chemotherapy
  • Peripheral lymph node of at least 2 cm and accessible for biopsy/harvest
  • No primary or secondary CNS lymphoma
  • Must not have any of the following:

    • Rapidly progressing lymphadenopathy
    • Bone marrow failure secondary to lymphoma
    • B symptoms
    • Neurovascular or organ compromise secondary to lymphoma



  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More than 1 year


  • Not specified


  • ALT/AST no greater than 3.5 times upper limit of normal
  • Bilirubin no greater than 1.5 mg/dL unless secondary to Gilbert's disease
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative


  • Creatinine no greater than 1.5 mg/dL


  • HIV negative
  • No active infection
  • No other prior or concurrent malignancy except curatively treated squamous cell or basal cell skin cancer or effectively treated carcinoma in situ of the cervix
  • No medical or psychiatric condition that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • See Disease Characteristics
  • No other concurrent biologic therapy for lymphoma


  • See Disease Characteristics
  • At least 3 months since prior PACE chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • At least 2 weeks since prior steroid treatment
  • Less than 2 months of prior prednisone
  • No concurrent endocrine therapy for lymphoma


  • Prior radiotherapy to no more than 1 site allowed
  • At least 2 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • See Disease Characteristics
  • Lymph node biopsy performed within past month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00020462

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United States, Maryland
Medicine Branch
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Sattva S. Neelapu, MD National Cancer Institute (NCI)
Publications of Results:
Layout table for additonal information Identifier: NCT00020462    
Obsolete Identifiers: NCT00008996
Other Study ID Numbers: CDR0000068505
First Posted: August 7, 2003    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: December 2008
Keywords provided by National Cancer Institute (NCI):
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
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
Additional relevant MeSH terms:
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Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents