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Brain and Central Nervous System TumorsPhase 1/2NCT00293423

GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Recurrent or Progressive Glioma

A Phase 1/2 study testing HSPPC-96 and Standard Surgical Resection in people with Brain and Central Nervous System Tumors, run by University of California, San Francisco at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Vaccines made from a person's tumor cells, such as gp96 heat shock protein-peptide complex, may help the body build an effective immune response to kill tumor cells. This phase I/II trial is studying the side effects and best dose of gp96 heat shock protein-peptide complex vaccine to see how well it works in treating… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
HSPPC-96 and Standard Surgical Resection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
3 sitesUnited States
Study dates
18 Nov 2005to 12 Jan 2013
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant recurrent glioma*, including any of the following:
  • Glioblastoma
  • Glioblastoma multiforme
  • Recurrent disease or progressive primary disease
  • Surgically accessible tumor for which surgical resection is indicated and has not been previously irradiated
  • Prior radiotherapy required
  • No prior oncophage therapy or immunotherapy for glioma

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 80-100%
  • Life expectancy ≥ 8 weeks
  • Absolute granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Alkaline phosphatase and serum glutamic-pyruvic transaminase (SGPT) <=2.5 times normal
  • Bilirubin < 1.5 mg/dL
  • Blood Urea Nitrogen (BUN) < 1.5 times normal OR creatinine < 1.5 times normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for at least 4 weeks after completion of study treatment
  • No uncontrolled active infection
  • No bleeding diathesis
  • No psychiatric or medical situation that would preclude study compliance
  • No unstable or severe concurrent medical condition
  • No other cancer or concurrent malignancy within the past 5 years except adequately treated nonmetastatic in situ carcinoma of the uterine cervix, nonmetastatic nonmelanoma skin cancer, or in complete remission and off all therapy for that disease
  • No systemic autoimmune disease (e.g., Hashimoto's thyroiditis) and/or any history of primary or secondary immunodeficiency

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 2 weeks since prior vincristine
  • At least 6 weeks since prior nitrosoureas
  • At least 4 weeks since prior temozolomide or other cytotoxic chemotherapy
  • At least 4 weeks since prior investigational agents
  • At least 1 week since prior noncytotoxic agents
  • At least 3 weeks since prior procarbazine
  • No radiotherapy within the past 4 weeks

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Columbia University

    New York, New York, 10032

  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: Phase I/II Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine for Patients With Recurrent High Grade Glioma

Vaccines made from a person's tumor cells, such as gp96 heat shock protein-peptide complex, may help the body build an effective immune response to kill tumor cells. This phase I/II trial is studying the side effects and best dose of gp96 heat shock protein-peptide complex vaccine to see how well it works in treating patients with recurrent or progressive high-grade glioma over time.

Read the detailed description

PRIMARY OBJECTIVES:

  • Phase 1: [closed to accrual as of 7/25/2007]: Determine the safety and best tolerated dose and frequency of gp96 heat shock protein-peptide complex vaccine in patients with recurrent or progressive high-grade glioma.
  • Phase 2: Determine the clinical response to treatment, time to disease recurrence and progression, and overall survival of patients treated with this vaccine.

SECONDARY OBJECTIVES:

  • Determine the immune response in patients treated with this vaccine.
  • Determine survival outcomes in patients treated with this vaccine.

OUTLINE: This is a dose-escalation, phase I study (closed to accrual as of 7/25/2007) followed by a phase II study.

PHASE I [closed to accrual as of 7/25/2007]:

Patients underwent surgical resection. Viable tumor tissue is used to generate the gp96 heat shock protein-peptide complex (HSPPC-96) vaccine. Patients with primary disease receive standard adjuvant therapy after surgery. Patients whose disease progresses during or after standard adjuvant therapy receive the HSPPC-96 vaccine. Patients with recurrent disease receive the HSPPC-96 vaccine between 2-8 weeks after surgery. The HSPPC-96 vaccine is administered intradermally every 1-3 weeks for at least 4 doses and then every 2-3 weeks thereafter in the absence of disease progression, unacceptable toxicity, or vaccine depletion. Cohorts of 6 patients received the HSPPC-96 vaccine at escalating dose frequencies until the maximum tolerated dose (MTD) was determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experienced a dose-limiting toxicity.

PHASE II: Patients received the HSPPC-96 vaccine as in phase I at the appropriate dose frequency determined in phase I (closed to accrual as of 7/25/2007). The HSPPC-96 vaccine is administered intradermally every 1-3 weeks for at least 4 doses and then every 2 weeks thereafter in the absence of disease progression, unacceptable toxicity, or vaccine depletion. After completion of study treatment, patients are followed periodically until death, lost to follow-up, or end of study.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Being tested
HSPPC-96, Standard Surgical Resection
Keywords
adult glioblastoma, recurrent adult brain tumor
Medical subject headings
Central Nervous System Neoplasms, Glioblastoma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HSPPC-96Biological

    Also called Heat Shock, Glycoprotein 96, Gp96

    25 mcg

  • Standard Surgical ResectionProcedure or surgery

    Also called Craniotomy

    Patients will undergo standard surgical resection of intracranial tumor

Study groups in NCT00293423
Study groupRoleWhat they receive
Phase 1: VaccineExperimentalPatients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections.
Receives: Biological: HSPPC-96; Procedure: Standard Surgical Resection
Phase 2: VaccineExperimentalTreatment consisted of 25 mcg of HSPPC-96 weekly for at least 4 weeks, followed by biweekly injections (pending vaccine availability) for up to 52 weeks from the date of surgical resection.
Receives: Biological: HSPPC-96; Procedure: Standard Surgical Resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD) (Phase 1)

    MTD determination will be based on the occurrence of dose-limiting toxicities. The MTD will be 1 dose below the dose that defined the dose-limiting toxicities

    Measured: Up to 4 weeks

  2. Frequency of gp96 Heat Shock Protein-peptide Complex Vaccine (Phase 1)

    The frequency of dosing of the first 4 injections to be recommended for Phase 2 will be determined by reviewing the reported number of dose-limiting toxicities for weekly or bi-weekly injections.

    Measured: Up to 6 months

  3. Number of Participants With Dose Limiting Toxicities (Phase 1)

    Systemic toxicity will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Dose-limiting toxicity is defined as any of the following that are attributable to vaccine therapy: Any grade 3, 4 or 5 toxicity, Any grade >=2 clinical autoimmunity with the potential to threaten critical organs (including lungs, heart, kidney, bowel, bone marrow, liver or central nervous system (CNS), or eyes), and any removal of a patient from therapy due to toxicity

    Measured: Up to 4 weeks

  4. Median Progression-free Survival at 6 Months (Phase 2)

    Measured: 6 months

  5. Percentage of Participants With Progression-free Survival at 12 Months (Phase 2)

    Defined as the percentage of participants with confirmed response and who have not progressed from date of surgical resection until death or censored at 12 months

    Measured: Up to 12 months

Secondary outcomes (6)

  1. Number of Patients With an Immunological Response (Phase 1)

    An immunological response is defined as an absolute lymphocyte count (ALC) less than the lower limit of normal (1.0 × 109cells/L), according to the standard laboratory reference range

    Measured: Up to 12 months

  2. Number of Patients With an Immunological Response (Phase 2)

    An immunological response is defined as an absolute lymphocyte count (ALC) less than the lower limit of normal (1.0 × 109cells/L), according to the standard laboratory reference range

    Measured: Up to 2 years

  3. Number of Participants With Grade 3 or Higher, Vaccine Treatment-Related Adverse Events by Toxicity (Phase 2)

    Vaccine treatment-related Adverse Events with a grade >=3 according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 will be reported.

    Measured: Up to 2 years

  4. Median Overall Survival (Phase 2)

    Overall survival is defined as the length of time from date of surgical resection until death or censored at end of study period

    Measured: Up to 2 years

  5. Percentage of Participants Surviving at 6 Months (Phase 2)

    Defined as the percentage of participants still alive from date of surgical resection until death or censored at 6 months

    Measured: Up to 6 months

  6. Percentage of Participants Surviving at 12 Months (Phase 2)

    Defined as the percentage of participants still alive from date of surgical resection until death or censored at 12 months

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2006 (estimated)
  2. Study start18 Nov 2005
  3. Primary completion12 Jan 2013
  4. Study completion12 Jan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00293423
Sponsor's protocol ID
05103
Other IDs
UCSF-H41995-27311-01, NCI-2011-01231, P50CA097257-06, R01CA164714-02
Status last verified
May 2021
First submitted
16 Feb 2006
Last updated
13 May 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Crane CA, Han SJ, Ahn B, Oehlke J, Kivett V, Fedoroff A, Butowski N, Chang SM, Clarke J, Berger MS, McDermott MW, Prados MD, Parsa AT. Individual patient-specific immunity against high-grade glioma after vaccination with autologous tumor derived peptides bound to the 96 KD chaperone protein. Clin Cancer Res. 2013 Jan 1;19(1):205-14. doi: 10.1158/1078-0432.CCR-11-3358. Epub 2012 Aug 7.

    PubMed 22872572

  • Bloch O, Crane CA, Fuks Y, Kaur R, Aghi MK, Berger MS, Butowski NA, Chang SM, Clarke JL, McDermott MW, Prados MD, Sloan AE, Bruce JN, Parsa AT. Heat-shock protein peptide complex-96 vaccination for recurrent glioblastoma: a phase II, single-arm trial. Neuro Oncol. 2014 Jan;16(2):274-9. doi: 10.1093/neuonc/not203. Epub 2013 Dec 12.

    PubMed 24335700

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HSPPC-96 and Standard Surgical Resection in people with Brain and Central Nervous System Tumors, run by University of California, San Francisco at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (Phase 1) (time frame: Up to 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00293423, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.

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