PHASE II, single arm, investigation of HSPPC-96 vaccine with concurrent temozolomide in patients with newly diagnosed Glioblastoma Multiforme

Investigator: Ricardo Komotar

Institutional Protocol #: 20110358

National Clinical Trials Identifier: NCT00905060

Funding Agency/Sponsor: Externally Peer Reviewed

Division: Cancer Center

Therapeutic Area: Neurological Cancer

Phase: Phase II

Enrolling Sites: Jackson Memorial Hospital, University of Miami Medical Group

Enrolling Since: 4/25/2012


Purpose/Abstract:


The Phase 2 trial is a single-arm investigation designed to evaluate safety, survival, and
immune response in patients treated with an autologous tumor-derived heat shock protein
peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly
for 4 consecutive weeks and monthly following standard treatment with radiation and
temozolomide.




Eligibility Criteria:


Inclusion Criteria:

Pre-surgery tissue acquisition Inclusion criteria

1. > or equal to 18 years old

2. Life expectancy of greater than 12 weeks.

3. Able to read and understand the informed consent document; must sign the informed
consent

4. Must have suspected diagnosis of Glioblastoma Multiforme with a surgical intent to
resect at least 90% of enhancing disease

5. Must be eligible for post-surgical treatment with radiotherapy and temozolomide

Post-radiation therapy/pre-vaccine eligibility Inclusion criteria

1. Agree to use contraception or abstain from sexual activity from the time of consent
through 1 month after the end of study drug administration

2. Negative serum pregnancy test for female patients of childbearing potential

3. Patients with histologically proven, non-progressive glioblastoma multiforme (GBM)

4. Patient must have received standard of care radiation and temozolomide therapy

5. Must have undergone a at least a 90% resection (determined by the PI) measured by
postoperative magnetic resonance imaging (MRI) scan, T1-weighted contrast scan, or CT
scan if clinically indicated, performed within 72 hours after surgery

6. All radiotherapy must be discontinued at least 2 weeks and no more than 5 weeks prior
to the first planned vaccine administration

7. Availability of at least 4 doses of vaccine (at least 4 vials for clinical
administration produced from the tumor provided)

8. Karnofsky functional status rating > or equal to 70

9. Adequate bone marrow function including the absence of lymphopenia (ANC > 1,500/ mm3;
ALC > 500/mm3 ; platelet count >100,000/mm3), adequate liver function (serum glutamic
oxaloacetic transaminase/ aspartate aminotransferase [AST], alanine amino transferase
[ALT], and alkaline phosphatase <2.5 times institutional upper limit of normals
[IULNs] and bilirubin (total) <1.5 mg*IULN), and adequate renal function (BUN and
creatinine <1.5 times IULNs

Exclusion Criteria:

Pre-surgery tissue acquisition

1. Current diagnosis of Human Immunodeficiency Virus (HIV testing is not required per
protocol)

2. Any prior diagnosis of any other cancer or other concurrent malignancy, with the
exception of adequately treated nonmetastatic in situ carcinoma of the uterine cervix
or nonmetastatic nonmelanoma skin cancer unless in complete remission and off all
therapy for that disease for a minimum of 5 years

3. Any systemic autoimmune disease (e.g., Hashimoto's thyroiditis) and/or any history of
primary or secondary immunodeficiency

4. Any prior therapy for glioma

5. Planned use or current use of other investigational therapy for the treatment of
glioma

Post-radiation therapy/pre-vaccine Exclusion

1. Inability to comply with study-related procedures

2. Prior diagnosis of any other cancer or other concurrent malignancy, with the
exception of adequately treated nonmetastatic in situ carcinoma of the uterine cervix
or nonmetastatic nonmelanoma skin cancer unless in complete remission and off all
therapy for that disease for a minimum of 5 years

3. Current or active use of chemotherapy (except temozolomide) or immune therapy

4. Contrast MRI findings (or CT scan if MRI is clinically contraindicated) consistent
with progression per protocol defined modified RANO criteriaProgression prior to
vaccination as determined by the Principal Investigator

5. Patients with active uncontrolled infection

6. Evidence of bleeding diathesis

7. Unstable or severe intercurrent medical conditions

8. Female patients who are pregnant or breastfeeding


Gender: Both

Minimum Age: 18 Years

Maximum Age: N/A

Accepts healthy volunteers: No

Please note that this is written for scientific review, and if there are any questions or clarifications needed, please contact

Cancer Center Studies
1-866-574-5124

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