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| Sponsor: | Dana-Farber Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00020670 |
Purpose
RATIONALE: Vaccines made from cancer cells may make the body build an immune response to kill cancer cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have acute lymphoblastic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: autologous tumor cell vaccine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study of Vaccination With Autologous CD40-Activated Acute Lymphoblastic Leukemia Cells |
| Study Start Date: | January 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Autologous acute lymphoblastic leukemia (ALL) cells are harvested, cultured with CD40 ligand, pulsed with keyhole limpet hemocyanin, and then irradiated.
Beginning a minimum of 1 week after tumor cell collection, patients receive vaccination with autologous CD40-activated ALL cells subcutaneously and intradermally on weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. After completion of 4 vaccinations, patients who have more aliquots of vaccine available from the initial tumor cell collection may receive additional vaccinations every 2 weeks in the absence of disease progression or unacceptable toxicity. Vaccination may be postponed for a maximum of 1 year after tumor cell collection in patients who receive chemotherapy and/or allogeneic stem cell transplantation.
Patients are followed at approximately 2 months after last vaccination.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of B-cell acute lymphoblastic leukemia
Must meet 1 of the following conditions:
In first relapse with at least 1 of the following high-risk features:
Successful generation of adequate CD40 ligand-activated autologous tumor cell vaccine
Patients in first relapse or beyond must be ineligible for or have declined allogeneic bone marrow transplantation in order to receive study vaccine
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Treatment portion of the study:
Renal:
Treatment portion of the study:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Tumor cell collection portion of the study:
Treatment portion of the study:
Chemotherapy:
Tumor cell collection portion of the study:
Treatment portion of the study:
Endocrine therapy:
Treatment portion of the study:
Radiotherapy:
Treatment portion of the study:
Surgery:
Other:
Tumor cell collection portion of the study:
Treatment portion of the study:
Both portions of the study:
Contacts and Locations| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| Study Chair: | W. Nicholas Haining, BM, BCh | Dana-Farber Cancer Institute |
More Information
| Study ID Numbers: | CDR0000068701, DFCI-00053, NCI-H01-0074 |
| Study First Received: | July 11, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00020670 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent childhood acute lymphoblastic leukemia recurrent adult acute lymphoblastic leukemia B-cell childhood acute lymphoblastic leukemia B-cell adult acute lymphoblastic leukemia |
|
Lymphatic Diseases Leukemia Neoplasms Leukemia, Lymphoid Immunoproliferative Disorders |
Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Immune System Diseases Lymphoproliferative Disorders |