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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01480479




Registration number
NCT01480479
Ethics application status
Date submitted
21/11/2011
Date registered
29/11/2011
Date last updated
16/01/2018

Titles & IDs
Public title
Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma
Scientific title
An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma
Secondary ID [1] 0 0
CDX110-04
Universal Trial Number (UTN)
Trial acronym
ACT IV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioblastoma 0 0
Small Cell Glioblastoma 0 0
Giant Cell Glioblastoma 0 0
Gliosarcoma 0 0
Glioblastoma With Oligodendroglial Component 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rindopepimut (CDX-110) with GM-CSF
Treatment: Drugs - Temozolomide
Treatment: Drugs - KLH

Experimental: Rindopepimut/GM-CSF plus Temozolomide -

Active comparator: KLH plus Temozolomide -


Treatment: Drugs: Rindopepimut (CDX-110) with GM-CSF
Two intradermal injections two weeks apart, followed by monthly injections until tumor progression or intolerance.

Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM CSF.

Treatment: Drugs: Temozolomide
150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, or until intolerance or progression.

Treatment: Drugs: KLH
Two intradermal injections two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8mL containing approximately 100mcg of KLH.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
During treatment and every three months from end of treatment through end of study or approximately up to 5 years.
Secondary outcome [1] 0 0
Progression-free survival
Timepoint [1] 0 0
Every 12 weeks from Day 1 through progression or initiation of other anti-cancer therapy
Secondary outcome [2] 0 0
Safety and Tolerability
Timepoint [2] 0 0
Until day 28 of follow up

Eligibility
Key inclusion criteria
Inclusion Criteria-

Among other criteria, patients must meet the following conditions to be eligible for the study:

1. Adult patients, = 18 years old
2. Newly diagnosed glioblastoma
3. Attempted surgical resection followed by conventional chemoradiation
4. Documented EGFRvIII positive tumor status by a Sponsor designated laboratory
5. No evidence of progressive disease from the post-operative period to the post-chemoradiation period
6. Candidate for, and agrees to receive, adjuvant (maintenance) temozolomide therapy
7. Systemic corticosteroid therapy at =2 mg of dexamethasone or equivalent per day for at least 3 days prior to randomization
8. WHO-ECOG Performance Status = 2
9. Patients of childbearing/reproductive potential will be instructed to use birth control as defined by your doctor.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria-

Among other criteria, patients who meet the following conditions are NOT eligible for the study:

1. Stereotactic biopsy only (without further surgical resection)
2. Presence of diffuse leptomeningeal disease, gliomatosis cerebri, or infratentorial disease.
3. History, presence, or suspicion of metastatic disease
4. Patients who have received any additional treatment for glioblastoma, aside from surgical resection and chemoradiation with temozolomide
5. Active systemic infection requiring treatment
6. History of any malignancy (other than glioblastoma) during the last three years except non-melanoma skin cancer, in situ cervical cancer, treated superficial bladder cancer, cured, early-stage prostate cancer in a patient with PSA level less than ULN,or other carcinoma in situ that has been adequately treated and cured.
7. Planned major surgery
8. Evidence of current drug or alcohol abuse
9. Known allergy or hypersensitivity to keyhole limpet hemocyanin (KLH), GM-CSF (sargramostim; LEUKINE®), polysorbate 80 or yeast derived products, or a history of anaphylactic reactions to shellfish proteins
10. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with participating in a clinical trial
11. Women who are pregnant or lactating

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2016
Sample size
Target
Accrual to date
Final
745
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
The Crown Princess Mary Cancer Centre, Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [5] 0 0
Mater Adult Hospital, Mater Misericordiae Health Services Brisbane Limited - South Brisbane
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Calvary North Adelaide Hospital - North Adelaide
Recruitment hospital [8] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [9] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [10] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [11] 0 0
Austin Health - Heidelberg
Recruitment hospital [12] 0 0
Epworth Healthcare - Richmond
Recruitment hospital [13] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [14] 0 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2605 - St Leonards
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
5006 - North Adelaide
Recruitment postcode(s) [8] 0 0
7000 - Hobart
Recruitment postcode(s) [9] 0 0
7250 - Launceston
Recruitment postcode(s) [10] 0 0
3199 - Clayton
Recruitment postcode(s) [11] 0 0
3084 - Heidelberg
Recruitment postcode(s) [12] 0 0
3121 - Richmond
Recruitment postcode(s) [13] 0 0
06008 - Nedlands
Recruitment postcode(s) [14] 0 0
2107 - Liverpool
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celldex Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Weller M, Butowski N, Tran DD, Recht LD, Lim M, Hi... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT01480479