GM-CSF Vaccinations After Allogeneic Blood Stem Cell Transplantation in Patients With Advanced Myeloid Malignancies

NCT00426205 | Completed DMC

• 1 other identifier: 04-023
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether the addition of a vaccine after participants reduced intensity transplant will be safe and beneficial. The vaccine used in this trial, called GVAX, will be made from the participants own leukemia cells, and will be given between 1-4 months after transplant. In recent years, researchers have discovered that GVAX vaccine made from the patient's own cancer calls that have been engineered in the laboratory to produce a protein called GM-CSF, can be effective in stimulating a powerful immune response specific to that cancer.

Conditions

Myelodysplastic Syndrome RAEB-I or RAEB-II; Refractory Acute Myeloid Leukemia; Refractory CML Myeloid Blast Crisis

Keywords

GM-CSF; GVAX; Cancer vaccine; blood stem cell transplantation; MDS; AML; CML

Outcome Measures

Primary Outcomes (1)

• Feasibility as measured by ability to generate sufficient vaccine, and ability for this patient population to initiate vaccination between day 30 to day 45 after transplant.

  3 years

Secondary Outcomes (3)

• Safety of GVAX vaccination as measured by grade III-IV acute GVHD, and CTC grade 3 or higher non-hematologic toxicity

  3 years

• biologic activity of GVAX vaccination

  3 years

• disease free and overall survival.

Interventions

GM-CSF secreting leukemia vaccine BIOLOGICAL

Vaccine given subcutaneously or intradermally on the leg, arm, or abdomen 6 times. The first three vaccines will be given once a week for three weeks. The last three vaccines will be given once every other week for three doses.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AML, MDS-RAEB or RAEB-T, CML, myeloid blast crisis not in remission or CML accelerated phase. Subjects must have \> 5% blasts in bone marrow or peripheral blood prior to admission for transplant.
• HLA 6/6 matched related or unrelated donor available
• ECOG Performance Statue 0-2
• years of age or older

You may not qualify if:

• Uncontrolled infection
• Leukemia with active CNS involvement
• Serum creatinine greater than 2.0 mg/dl
• ALT or AST greater than 3 x ULN
• Total bilirubin greater than 2.0 mg/dl
• Positive HIV or HTLV-1 serology
• Prior allogeneic stem cell transplant

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Ho VT, Vanneman M, Kim H, Sasada T, Kang YJ, Pasek M, Cutler C, Koreth J, Alyea E, Sarantopoulos S, Antin JH, Ritz J, Canning C, Kutok J, Mihm MC, Dranoff G, Soiffer R. Biologic activity of irradiated, autologous, GM-CSF-secreting leukemia cell vaccines early after allogeneic stem cell transplantation. Proc Natl Acad Sci U S A. 2009 Sep 15;106(37):15825-30. doi: 10.1073/pnas.0908358106. Epub 2009 Aug 26.

  PMID: 19717467 BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Vincent Ho, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2007
• First Posted: January 24, 2007
• Study Start: June 1, 2004
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2009
• Last Updated: February 11, 2022

Record last verified: 2022-01

Locations

US (1)