Peptide-based Glioma Vaccine IMA950 in Patients With Glioblastoma

• Status: Terminated
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

BACKGROUND: Active immunotherapy of cancer is based on the premise that the vaccine raises a cytotoxic immune response to tumor-associated antigens, thereby destroying malignant cells without harming normal cells.

IMA950 is a therapeutic multi-peptide vaccine containing 11 tumor-associated peptides (TUMAPs) found in a majority of glioblastomas, and is designed to activate TUMAP-specific T cells. The use of 11 TUMAPs increases the likelihood of a multi-clonal, highly specific T-cell response against tumor cells leading to decreased likelihood of immune evasion of the tumor by down-regulation of target antigens.

PURPOSE: The primary objective of this study is to determine the safety and tolerability of IMA950 when given with cyclophosphamide, granulocyte macrophage-colony stimulating factor (GM-CSF) and imiquimod in patients with glioblastoma and to determine if IMA950 shows sufficient immunogenicity in these patients.

ELIGIBILITY: Patients with histologically proven GBMs who have completed radiotherapy, and have stable disease following at least 4 cycles of adjuvant temozolomide.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: immatics Biotechnologies GmbH
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Imiquimod; Molgramostim; Sargramostim

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven glioblastoma

• Stable disease following ≥ 4 cycles of adjuvant temozolomide

• No progression or recurrence of disease

PATIENT CHARACTERISTICS:

• HLA-A*02 positive

• ≥ 18 years old

• Life expectancy > 8 weeks

• Karnofsky performance status ≥ 60

• WBC >3,500/µL

• ALC >350/mm3

• ANC >1,500/mm3

• Platelet count >100,000/mm3

• Hemoglobin >10gm/dL

• AST, ALT and alkaline phosphatase <2.5 times upper limit of normal (ULN)

• Bilirubin <1.5 times ULN

• Creatinine <1.5 mg/dL and/or creatinine clearance >60cc/min

• Serum potassium, magnesium and calcium within normals levels (supplementation is allowed)

• Not pregnant or nursing

• Negative pregnancy test

• Practice birth control during and for 2 months after treatment with IMA950 (both genders)

• Women of childbearing age must agree to use adequate contraceptive methods

• No significant active hepatic, renal, infectious or psychiatric disease

• No HIV, active hepatitis infection, or any other active severe infectious disease

• No history of autoimmune disease or immunosuppression

• No clinically significant cardiovascular event within 3 months before study entry or an increased risk for ventricular arrhythmia

• No malignancy other than glioblastoma that required treatment during the last 12 months

PRIOR and/or CONCURRENT THERAPY:

• See Disease Characteristics

• Completed radiotherapy and at least 4 cycles of adjuvant temozolomide

• Not be receiving steroids OR be on stable dose of steroids for ≥ 5 days prior to registration

• No other prior immunotherapy for glioblastoma

• No major surgery within 4 weeks prior to treatment start

• At least 4 weeks from cytotoxic therapies (incl. temozolomide)

• At least 2 weeks from non-cytotoxic therapies (e.g. interferon, tamoxifen)

• At least 3 weeks from bevacizumab

• No current treatment with imiquimod; prior use of imiquimod is allowed