Clinical trial

Pilot Trial to Evaluate Immune Response Using Idiotype Vaccines Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Follicular Lymphoma

Name

0260-00-FB

Description

RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Vaccine therapy may be an effective treatment for non-Hodgkin's lymphoma. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy following chemotherapy and peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma.

Trial arms

Trial start

2000-10-11

Estimated PCD

2008-04-03

Trial end

2008-04-03

Status

Terminated

Phase

Early phase I

Treatment

autologous tumor cell vaccine

Arms:

Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation

keyhole limpet hemocyanin

Arms:

Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation

sargramostim

Arms:

Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation

Other names:

Leukine

adjuvant therapy

Arms:

Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation

Size

Primary endpoint

Number of Participants With Humoral and Cellular Immune Response

immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression

Eligibility criteria

Inclusion Criteria: * Over 19 years of age * Histologically proven grade I, II, or III follicular non-Hodgkin's lymphoma that failed induction therapy * Minimal disease state at day 100 to 6 months post-transplantatio * Lymph nodes smaller than 2 centimeters (cm) * Less than 20% bone marrow involvement with lymphoma * Uncertain complete remission, defined by greater than 75% reduction in the size of the pre-transplantation mass not representing active disease * Tissue sample safely accessible by biopsy, needle aspiration, or phlebotomy o Must have adequate circulating lymphoma cells * Karnofsky greater than 70% * Absolute neutrophil count greater than 1,000/mm\^3 (No restrictions if study vaccine administered at 6 months after transplantation) * CD4+ count greater than 200/microliter (No restrictions if study vaccine administered at 6 months after transplantation) * Bilirubin less than 2.0 mg/dL (unless due to lymphomatous involvement) * Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) less than 2 times normal (unless due to lymphomatous involvement) * Creatinine no greater than 2.0 mg/dL * Fertile patients must use effective contraception during and for 6 months after study participation Exclusion Criteria: * Previously received no more than 2 high-dose chemotherapies before hematopoietic stem cell transplantation * Not pregnant or nursing/negative pregnancy test

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 19, 'type': 'ACTUAL'}}

Updated at

2023-09-18

1 organization

2 products

1 drug

1 indication

Organization

University of Nebraska

Product

Autologous Tumor Cell Vaccine

Indication

lymphoma

Product

Keyhole Limpet Hemocyanin

Drug

sargramostim