NCT00020462

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

August 7, 2003

Completed
Last Updated

April 30, 2015

Status Verified

December 1, 2008

First QC Date

July 11, 2001

Last Update Submit

April 29, 2015

Conditions

Lymphoma

Keywords

stage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphoma

Interventions

aldesleukinBIOLOGICAL
autologous tumor cell vaccineBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Medicine Branch

Bethesda, Maryland, 20892, United States

Location

Related 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. doi: 10.1182/blood-2006-12-063594. Epub 2007 Mar 5.

    PMID: 17339422RESULT

MeSH Terms

Conditions

LymphomaLymphoma, Follicular

Interventions

aldesleukinFANG vaccine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-Hodgkin

Study Officials

  • Sattva S. Neelapu, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

August 7, 2003

Study Start

February 1, 2001

Last Updated

April 30, 2015

Record last verified: 2008-12

Locations

US(1)