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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Sattva S. Neelapu, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000068505

NCT ID:

NCT00020462

Start Date:

February 2001

Completion Date:

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Follicular

Name

Location

Medicine BranchBethesda, Maryland  20892