Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Herbal and Botanical

All Drugs and Chemicals

Cola

standard surgical resection using clamps and surgical ligatures

Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon

Standard Surgical resection

resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon

LIGASURE

The objective of this prospective randomized surgical trial is to evaluate whether the use of the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with ovarian cancer will reduce the surgical time compared to standard surgical resection using clamps and surgical ligatures.

This research study is a prospective, randomized trial. Women who are suspected to have an early or late stage ovarian cancer during their preoperative evaluation will be potential study participants. Only patients with documented ovarian cancer by histologic examination at the time of the cytoreductive or staging surgery, and that are also undergoing omentectomy and/or recto-sigmoid colon resection will be eligible for participation. Patients who are eligible for participation and who are willing to participate will be randomized during the surgical procedure to standard surgical resection using clamps and surgical ligatures versus resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon. The resection of these tissues will be performed as part of the usual surgical protocol for women with ovarian cancer and will not be done so unless the tissues are the sites of metastatic disease or if their removal would be performed for staging purposes.

Surgical Trial Comparing LIGASURE Assisted Recto-Sigmoid Resection and Omentectomy Compared to Stand

A Prospective Randomized Surgical Trial Comparing the Efficacy of LIGASURE Assisted Recto-Sigmoid Resection and Omentectomy Compared to Standard Surgical Resection in Women With Stage IIIC or Stage IVA Epithelial Ovarian Cancer

To evaluate whether the use of the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with ovarian cancer will reduce the surgical time compared to standard surgical resection using clamps and surgical ligatures

University of Utah

standard surgical resection using clamps and surgical ligatures

Standard Surgical resection: standard surgical resection using clamps and surgical ligatures

Standard Surgical Resection

Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon

LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon

Total

< 50 years

50-70 years

>70 years

Age, Customized

Sex: Female, Male

Mark Wade

Surgical Time

Overall Study

Symptoms and General Pathology

Nervous System Diseases

Recurrence

Glioblastoma

Glioma

Shock

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Tumor, Adult

Anti-Infective Agents

Antineoplastic Agents

Vaccines

polysaccharide-K

Adjuvants, Immunologic

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antiviral Agents

Interferons

Protective Agents

Radiation-Protective Agents

Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections.

Treatment 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.

HSPPC-96

Patients will undergo standard surgical resection of intracranial tumor

Jennifer Clarke, MD

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.

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.

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

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

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

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.

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

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

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

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.

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

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

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

National Cancer Institute (NCI)

Agenus Inc.

American Brain Tumor Association

University of California, San Francisco

Principal Investigator

Phase 1: Vaccine

Phase 2: Vaccine

20-29 years old

30-39 years old

40-49 years old

50-59 years old

60-69 years old

70-79 years old

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Vaccines were only given to the intent-to-treat population

Median Number of Vaccine Doses Administered

Dr. Orin Bloch

Patients received 25 micrograms of HSPPC-96 bi-weekly or weekly for the first 4 vaccinations followed by biweekly injections

Maximum Tolerated Dose (MTD) (Phase 1)

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

Number of Participants With Dose Limiting Toxicities (Phase 1)

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

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

Number of Patients With an Immunological Response (Phase 1)

Number of Patients With an Immunological Response (Phase 2)

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

Median Overall Survival (Phase 2)

Percentage of Participants Surviving at 6 Months (Phase 2)

Percentage of Participants Surviving at 12 Months (Phase 2)

Surgical Resection

Vaccination Treatment Period

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients will receive 4 weekly injections of HSPPC-96 followed by a 5th vaccine injection on the same day of the start of maintenance temozolomide administered 2 weeks (+ 4 days) following vaccine administration #4 on the same day of the start of maintenance temozolomide (Day 36). Monthly vaccine injections will then begin on day 21 (+/- 7 days) of the first 28 day temozolomide cycle (Day 56 of the study), 3 weeks following vaccine administration #5 and will continue every 28 days until depletion of vaccine or progression.

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.

Maintenance temozolomide treatment is given 2 weeks after administration of the fourth vaccine at an initial dose of 150 mg per square meter (mg/m2) for 5 consecutive days in a 28-day cycle. The dose was increased to 200 mg/m2 for 5 days in subsequent cycles.

This phase II trial studies the side effects and how well HSPPC-96 (vitespen) and temozolomide work in treating patients with newly diagnosed glioblastoma multiforme. Vaccines made from a person's tumor cells and heat shock protein peptide may help the body to build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving HSPPC-96 (vitespen) together with temozolomide may kill more tumor cells.

PRIMARY OBJECTIVES:

I. To evaluate the safety profile of HSPPC-96 (vitespen) administered concurrently with temozolomide in patients with newly diagnosed glioblastoma multiforme (GBM).

II. To evaluate survival in patients treated with an autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) with concurrent temozolomide.

SECONDARY OBJECTIVES:

I. To evaluate progression-free survival (PFS) from date of surgical resection. II. To evaluate the immunologic response to vaccine treatment in a subset of evaluable patients.

OUTLINE:

Approximately 2-5 weeks after standard radiation therapy and temozolomide completion, patients receive vitespen intradermally (ID) on days 1, 8, 15, and 22. Beginning 2 weeks after the 4th dose of vitespen, patients receive a 5th dose of vitespen ID and maintenance temozolomide orally (PO) on days 1-5 (of 28 day courses). On day 21 of course 1, patients receive the 6th dose of vitespen ID and continue vaccinations monthly. Courses repeat every 28 days in the absence of vaccine depletion, disease progression, or unacceptable toxicity.

After completion of study treatment, patients are followed up every 12 weeks.

HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed GBM

PHASE 2, Multi-center, Single Arm Investigation of HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

Overall survival is defined as the time from surgical resection to death of any cause.

PFS is defined as the duration of progression-free survival from the time from resection until either documented disease progression or death

Circulating myeloid cells (CD45+/CD11b+) obtained from patients at the time of surgery were analyzed for PD-L1 expression to determine the percent of myeloid cells positive for PD-L1 (cut off for positivity determined relative to Fluorescence Minus One (FMO) and isotype control).

Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)

Patients will receive 4 weekly injections of HSPPC-96 followed by a 5th vaccine injection on the same day of the start of maintenance temozolomide administered 2 weeks (+ 4 days) following vaccine administration #4 on the same day of the start of maintenance temozolomide (Day 36). Monthly vaccine injections will then begin on day 21 (+/- 7 days) of the first 28 day temozolomide cycle (Day 56 of the study), 3 weeks following vaccine administration #5 and will continue every 28 days until depletion of vaccine or progression.

HSPPC-96: 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Surgical Trial Comparing LIGASURE Assisted Recto-Sigmoid Resection and Omentectomy Compared to Stand	NCT01549925	Epithelial Ovar...	Standard Surgic... LIGASURE	18 Years -	University of Utah
GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Recurrent or Progressive Glioma	NCT00293423	Brain and Centr...	HSPPC-96 Standard Surgic...	18 Years -	University of California, San Francisco
Surgical Trial Comparing LIGASURE Assisted Recto-Sigmoid Resection and Omentectomy Compared to Stand	NCT01549925	Epithelial Ovar...	Standard Surgic... LIGASURE	18 Years -	University of Utah
HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed GBM	NCT00905060	Brain and Centr...	HSPPC-96 Temozolomide Standard Surgic...	18 Years -	University of California, San Francisco

Spots Global Cancer Trial Database for standard surgical resection