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Peptide-based Glioma Vaccine IMA950 in Patients With Glioblastoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01403285
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Immatics Biotechnologies GmbH
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Teri Kreisl, MD
Principal Investigator Affiliation Neuro-Oncology Branch of the National Cancer Institute, National Institutes of Health, Bethesda, MD
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry, NIH
Overall Status Terminated
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bethesda, Maryland

Status

Address

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

Bethesda, Maryland, 20892

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