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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
autologous tumor cell vaccine
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medicine Branch

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 11, 2001
Last Updated
April 29, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00020462
Brief Title
Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III, Stage IV, or Recurrent Follicular Lymphoma
Official Title
Active Specific Immunotherapy for Follicular Lymphomas With Liposomes Containing Tumor-Derived Antigen and IL-2
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
autologous tumor cell vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sattva S. Neelapu, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
Medicine Branch
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17339422
Citation
Neelapu SS, Gause BL, Harvey L, Lee ST, Frye AR, Horton J, Robb RJ, Popescu MC, Kwak LW. A novel proteoliposomal vaccine induces antitumor immunity against follicular lymphoma. Blood. 2007 Jun 15;109(12):5160-3. doi: 10.1182/blood-2006-12-063594. Epub 2007 Mar 5.
Results Reference
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Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III, Stage IV, or Recurrent Follicular Lymphoma

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