Peptide-based Glioma Vaccine IMA950 in Patients With Glioblastoma

NCT ID: NCT01403285

Last Updated: 2014-05-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-04-30

Brief 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.

Conditions

Glioblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Cyclophosphamide

One single low-dose i.v. infusion of cyclophosphamide (300mg/m2) prior to the first vaccination as pre-treatment

Intervention Type: DRUG

IMA950 plus GM-CSF

Six vaccinations with IMA950 plus GM-CSF as adjuvant on 8 pre-defined days from Day 1 to Day 78

Intervention Type: BIOLOGICAL

IMA950

After Day 78, vaccinations with IMA950 (no GM-CSF) will be given on a monthly basis for up to one year from start of vaccination or until disease progression

Intervention Type: BIOLOGICAL

Imiquimod

Imiquimod will be topically applied 10-20 minutes after each vaccination. After the third vaccination onward patients will apply additional imiquimod 24 hours after each vaccination at home on their own

Intervention Type: DRUG

Other Intervention Names

- Cytoxan (US name); - Endoxan (EU name); - Granulocyte macrophage-colony stimulating factor; - Sargramostim; - Leukine; - Aldara

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Immatics Biotechnologies GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teri Kreisl, MD

Role: PRINCIPAL_INVESTIGATOR

Neuro-Oncology Branch of the National Cancer Institute, National Institutes of Health, Bethesda, MD

Locations

Neuro-Oncology Branch of the National Cancer Institute, National Institutes of Health

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

11C0192

Identifier Type: OTHER

Identifier Source: secondary_id

IMA950-102

Identifier Type: -

Identifier Source: org_study_id

NCT01386463

Identifier Type: -

Identifier Source: nct_alias