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

April 29, 2015 updated by: National Cancer Institute (NCI)

Active Specific Immunotherapy for Follicular Lymphomas With Liposomes Containing Tumor-Derived Antigen and IL-2

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Medicine Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More than 1 year

Hematopoietic:

  • Not specified

Hepatic:

  • 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

Renal:

  • Creatinine no greater than 1.5 mg/dL

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Study Chair: Sattva S. Neelapu, MD, National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Study Registration Dates

First Submitted

July 11, 2001

First Submitted That Met QC Criteria

August 6, 2003

First Posted (Estimate)

August 7, 2003

Study Record Updates

Last Update Posted (Estimate)

April 30, 2015

Last Update Submitted That Met QC Criteria

April 29, 2015

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068505
  • NCI-01-C-0069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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