Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia

Early Phase 1

Terminated

• Conditions: Leukemia
• Interventions: Biological: CD 40

• Registration Number: NCT00020670
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

The prognosis for children and adults with acute lymphoblastic leukemia (ALL) has improved significantly over the years. Nevertheless, patients who experience disease relapse or induction failure along with patients having unfavorable genetics \[t(4;11) or t(9;22)\] have dismal prognosis. For these patients, novel therapeutic approaches such as immunotherapy are needed. In this clinical trial, investigators evaluate whether it is feasible to make a vaccine from leukemia cells and whether this vaccine enables direct immunity against cancer cells in patients.

Detailed Description

OBJECTIVES Primary

* To determine feasibility of generating a cellular vaccine composed of CD40-activated autologous ALL cells

* To determine feasibility of vaccine administration according to the proposed schedule

* To determine toxicity of vaccination with CD40-activated autologous ALL cells

Secondary

* To assess ALL-specific immunity following vaccination

* To assess the generation of immunity to control antigens

* To develop preliminary information on effect vaccination on tumor response

Study Timeline

• Study Start: 2001-02-20
• Study First Submitted: 2001-07-11
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2003-04-01
• Study Completion: 2003-07-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD40 Cell Vaccination	CD 40	Patients will undergo tumor cell collection followed by vaccine preparation and then vaccination. Autologous acute lymphoblastic leukemia (ALL) cells are harvested, cultured with CD40 ligand, pulsed with keyhole limpet hemocyanin (KLH), and then irradiated to produce the vaccine. Patients receive either 1 x 10\^7 or 1 x 10\^8 CD40 cells/vaccination depending on the number of tumor cells obtained. Vaccinations are administered every two weeks as outpatient therapy. Evaluable patients receive the course of at least 4 vaccinations at weeks 0, 2, 4, 6. Patients may continue receiving vaccinations every 2 weeks if chemotherapy is not required for symptomatic disease.

Primary Outcome Measures

Name	Time	Method
Rate Of Successful Vaccine Preparation	6 weeks	Vaccine preparation is a success if an adequate number of CD40 activated cells (at least 1 x 10\^8 cells) can be generated.

Trial Locations

Locations (2)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States