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Vaccines

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vitespen

Jonathan Lewis, MD, PhD, FACS

RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to and kill tumor cells. Combining vaccine therapy with surgery may be an effective treatment for pancreatic cancer.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients with stage I or stage II pancreatic cancer that has been surgically removed.

OBJECTIVES: I. Study the safety of autologous tumor derived gp96 heat shock protein peptide complex (HSPPC-96) in patients with resected pancreatic adenocarcinoma. II. Examine the immune response to HSPPC-96 in this group of patients.

OUTLINE: This is a dose escalation study. Six weeks after surgery patients are given autologous tumor derived gp96 heat shock protein peptide complex (HSPPC-96) subcutaneously once a week for 4 weeks. Five patients are initially enrolled at each of two dose levels. An additional three patients may be enrolled at each dose level to determine the optimal dose of HSPPC-96. Patients are followed at weeks 1, 4, and 12 after treatment.

PROJECTED ACCRUAL: A maximum of 16 patients will be accrued for this study.

Vaccine Therapy in Treating Patients With Stage I or Stage II Pancreatic Cancer

A Phase I Pilot Trial of Immunotherapy With Autologous Tumor-Derived gp96 Heat Shock Protein - Peptide Complex (HSPPC-96) in Patients With Resected Pancreatic Adenocarcinoma

Memorial Sloan Kettering Cancer Center

Recurrence

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Robert Maki, MD, PhD

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent soft tissue sarcoma.

OBJECTIVES: I. Determine the efficacy of autologous tumor cell-derived heat shock protein peptide vaccine in terms of the rate of complete and partial response and time to progression in patients with recurrent soft tissue sarcoma. II. Determine the safety and tolerability of this treatment regimen in this patient population. III. Determine the anti-tumor response to this treatment regimen in these patients.

OUTLINE: At approximately 5 weeks after surgery, patients receive autologous tumor cell-derived heat shock protein peptide vaccine intradermally weekly for 4 weeks. Patients receive subsequent vaccinations once every 2 weeks for at least 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with improving or stable disease or without recurrence continue on therapy for up to 1 year.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Vaccine Therapy in Treating Patients With Recurrent Soft Tissue Sarcoma

A Phase II Trial of Active Specific Immunotherapy in Patients With Recurrent Soft Tissue Sarcoma Using Autologous Tumor-derived Heat Shock Protein-Peptide Complex (HSPPC-96)

National Cancer Institute (NCI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vaccine Therapy in Treating Patients With Stage I or Stage II Pancreatic Cancer	NCT00003025	Pancreatic Canc...	vitespen	18 Years -	Memorial Sloan Kettering Cancer Center
Vaccine Therapy in Treating Patients With Stage I or Stage II Pancreatic Cancer	NCT00003025	Pancreatic Canc...	vitespen	18 Years -	Memorial Sloan Kettering Cancer Center
Vaccine Therapy in Treating Patients With Recurrent Soft Tissue Sarcoma	NCT00005628	Sarcoma	vitespen	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for vitespen

Every month we try and update this database with for vitespen cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for vitespen

Every month we try and update this database with for vitespen cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vitespen cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.