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A Phase I Study of Vaccination With Autologous CD40-Activated Acute Lymphoblastic Leukemia Cells


Phase 1
N/A
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

A Phase I Study of Vaccination With Autologous CD40-Activated Acute Lymphoblastic Leukemia Cells


OBJECTIVES:

- Determine the feasibility of generating a vaccine comprising CD40-activated autologous
leukemic cells for patients with B-cell acute lymphoblastic leukemia (ALL).

- Determine the feasibility of this regimen in patients with B-cell ALL.

- Determine the toxicity of this regimen in these patients.

- Assess the ALL-specific immunity in patients treated with this regimen.

- Assess the generation of immunity to control antigens in patients treated with this
regimen.

- Determine, in a preliminary manner, the effect of this regimen on tumor response in
these patients.

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of B-cell acute lymphoblastic leukemia

- Disease involving at least 30% of bone marrow or circulating blasts

- Must meet 1 of the following conditions:

- 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

PATIENT CHARACTERISTICS:

Age:

- See Disease Characteristics

Performance status:

- Lansky 60-100% OR

- Karnofsky 60-100%

Life expectancy:

- Not specified

Hematopoietic:

- See Disease Characteristics

Hepatic:

- Treatment portion of the study:

- Bilirubin less than 2 times normal

- AST less than 3 times normal

- ALT less than 6 times normal

Renal:

- Treatment portion of the study:

- Creatinine less than 2 times normal

Cardiovascular:

- No clinically significant cardiovascular disease

Pulmonary:

- No clinically significant pulmonary disease

Other:

- No clinically significant autoimmune disease

- No documented infection that is active and/or not responding to therapy

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

- Tumor cell collection portion of the study:

- At least 3 days since prior immunotherapy

- Treatment portion of the study:

- Prior allogeneic hematopoietic stem cell transplantation allowed

- No immunotherapy for at least 3 weeks before and during study vaccination

- No concurrent hematopoietic growth factors

Chemotherapy:

- Tumor cell collection portion of the study:

- At least 3 days since prior chemotherapy

- Treatment portion of the study:

- No chemotherapy for at least 3 weeks before and during study vaccination

Endocrine therapy:

- Treatment portion of the study:

- No concurrent oral or IV corticosteroids as antiemetics

Radiotherapy:

- Treatment portion of the study:

- No radiotherapy for at least 3 weeks before and during study vaccination

Surgery:

- Not specified

Other:

- Tumor cell collection portion of the study:

- At least 3 days since prior immunosuppressive therapy

- Treatment portion of the study:

- No immunosuppressive therapy for at least 3 weeks before and during study
vaccination

- No concurrent local anesthetic cream (e.g., EMLA)

- Both portions of the study:

- No concurrent therapy on another research protocol

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

W. Nicholas Haining, BM, BCh

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000068701

NCT ID:

NCT00020670

Start Date:

January 2001

Completion Date:

Related Keywords:

  • Leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent adult acute lymphoblastic leukemia
  • B-cell childhood acute lymphoblastic leukemia
  • B-cell adult acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Dana-Farber Cancer InstituteBoston, Massachusetts  02115