Peptide-based Glioma Vaccine IMA950 in Patients With Glioblastoma

Immatics

Status and phase

Terminated

Phase 1

Conditions

Glioblastoma

Treatments

Biological: IMA950

Drug: Imiquimod

Drug: Cyclophosphamide

Biological: IMA950 plus GM-CSF

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT01403285

IMA950-102

11C0192 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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