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A Phase 1 Trial of Peptide-Based Glioma Vaccine IMA950 in Patients With Glioblastoma (GBM)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma

Thank you

Trial Information

A Phase 1 Trial of Peptide-Based Glioma Vaccine IMA950 in Patients With Glioblastoma (GBM)

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of IMA950 administered with granulocyte macrophage colony stimulating factor (GM-CSF) and topical imiquimod together following a single low-dose application of cyclophosphamide.

Outcome Description:

Number of AEs and percentage of patients with AEs (listed per grade and MedDRA preferred terms) will be reported.

Outcome Time Frame:

Continuously for up to 1 year plus follow-up

Safety Issue:

Yes

Principal Investigator

Joohee Sul, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Food and Drug Administration

Study ID:

IMA950-102

NCT ID:

NCT01403285

Start Date:

August 2011

Completion Date:

March 2014

Related Keywords:

  • Glioblastoma
  • Glioblastoma
  • stable disease
  • Glioblastoma

Name

Location

Neuro-Oncology Branch of the National Cancer Institute, National Institutes of HealthBethesda, Maryland  20892