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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00020462
• Other study ID #: CDR0000068505
• Secondary ID: NCI-01-C-0069
• Status: Completed
• Phase: Phase 1
• First received: July 11, 2001
• Last updated: April 29, 2015
• Start date: February 2001

Study information

• Verified date: December 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00008996

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Intervention

Biological:
• aldesleukin

• autologous tumor cell vaccine

Locations

Country	Name	City	State
United States	Medicine Branch	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2007 Mar 5. — View Citation