NCT00020670

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.

Trial Health

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Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for early_phase_1 leukemia

Timeline
Completed

Started Feb 2001

Shorter than P25 for early_phase_1 leukemia

Geographic Reach
1 country

2 active sites

Status
terminated

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 20, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

2.1 years

First QC Date

July 11, 2001

Last Update Submit

June 19, 2017

Conditions

Leukemia

Keywords

recurrent childhood acute lymphoblastic leukemiarecurrent adult acute lymphoblastic leukemiaB-cell childhood acute lymphoblastic leukemiaB-cell adult acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

  • Rate Of Successful Vaccine Preparation

    Vaccine preparation is a success if an adequate number of CD40 activated cells (at least 1 x 10\^8 cells) can be generated.

    6 weeks

Study Arms (1)

CD40 Cell Vaccination

EXPERIMENTAL

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.

Biological: CD 40

Interventions

CD 40BIOLOGICAL
Also known as: Autologous tumor cell vaccine
CD40 Cell Vaccination

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • B-cell acute lymphoblastic leukemia
  • Disease involving at least 30% of bone marrow or circulating blasts
  • In first relapse with at least 1 of the following high-risk features:
  • Age under 1 year at diagnosis
  • Age over 18 years at diagnosis
  • t(9;22)
  • Occurrence of first relapse less than 18 months after diagnosis
  • In second relapse or beyond
  • Refractory disease
  • Successful generation of adequate CD40 ligand-activated autologous tumor cell vaccine
  • Less than 1 year since tumor cell collection
  • Patients in first relapse or beyond must be ineligible for or have declined allogeneic bone marrow transplantation in order to receive study vaccine
  • Patients need not be in complete remission to receive study vaccine
  • Patients may have received an allogeneic hematopoetic stem cell transplant in the past
  • No chemotherapy, radiotherapy, immunotherapy or immunosuppressive treatment or within 3 weeks of vaccination
  • +3 more criteria

You may not qualify if:

  • Concurrent treatment as part of another therapeutic research protocol
  • Pregnancy or nursing mothers
  • Clinically significant pulmonary or cardiac disease
  • Clinically significant autoimmune disease
  • Documented infection that is active and/or not responding to therapy
  • Evidence of HIV infection or known positive HIV serology
  • Lansky performance scale (if \<18yo) \<60%, Karnofsky performance scale (if \>18yo) \>60%
  • Once vaccination course has started: patients may not receive chemotherapy, radiotherapy, immunotherapy or immunosuppressive treatment, hematopoetic growth factors. However between tumor cell collection and vaccine administration, patients may receive non-protocol chemotherapy.
  • \*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*NOTE\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*
  • It is anticipated that there will be a number of patients at first relapse who are eligible for tumor cell collection and vaccine preparation but who are not eligible to receive the vaccination course. These patients will be evaluable for Objective 3.1.1 (feasibility of vaccine preparation). Patients at first relapse who are eligible for vaccine preparation but not administration should instead be treated with standard salvage regimens which may include allogeneic bone marrow transplantation according to the judgement of their primary oncologist. However, these patients represent a population at extremely high risk for progression of their disease following salvage therapy. Many of these patients will therefore be likely to fulfill eligibility criteria for vaccination in the future (i.e.
  • should they relapse again, or fail to enter 2nd complete remission). The majority of those patients who relapse for a second time will do so within 1 year. Those patients who become eligible for vaccination because of 2nd relapse within 1 year of tumor cell collection will receive the original vaccine and will not have further vaccine made from tumor cells collected at the time of 2nd relapse. Given the proliferative thrust of the disease in many patients, it will be advantageous to have vaccines already prepared for these patients to reduce the amount of time from 2nd relapse to vaccination.\*\*\*

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

FANG vaccine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • W. Nicholas Haining, BM, BCh

    Dana-Farber Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Haining, Nicholas MD

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

February 20, 2001

Primary Completion

April 1, 2003

Study Completion

July 1, 2003

Last Updated

June 20, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)