Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor

Sarcoma Clinical Trial

Official title:

A Phase I Study Of Vaccination With Telomerase Peptide Plus GM-CSF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00069940
• Other study ID #: 03-365
• Secondary ID: P30CA006516
• Status: Completed
• Phase: Phase 1
• First received: October 3, 2003
• Last updated: December 26, 2010
• Start date: December 2000
• Est. completion date: August 2008

Study information

• Verified date: December 2010
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may cause a stronger immune response and kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects of vaccine therapy when given together with sargramostim in treating patients with advanced sarcoma or brain tumor.

Description:

OBJECTIVES:

• Determine the feasibility of treatment with telomerase: 540-548 peptide vaccine and sargramostim (GM-CSF) in patients with sarcoma or brain tumor.

• Determine the safety and tolerability of this regimen in these patients.

• Determine the frequency of T-cell specific vaccine antigens during and after administration of this regimen in these patients.

• Determine, preliminarily, the clinical response, if any, of patients treated with this regimen.

OUTLINE: Patients receive telomerase: 540-548 peptide vaccine subcutaneously (SC) on day 3 and sargramostim (GM-CSF) SC on days 1-4 of weeks 1, 3, 5, 7, 9, 11, 15, 19, and 23.

PROJECTED ACCRUAL: A total of 35 patients (20 adult and 15 pediatric) will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2008
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed diagnosis of 1 of the following malignancies:

• Stage III or IV sarcoma, including:

• Leiomyosarcoma

• Synovial cell sarcoma

• Liposarcoma

• Gastrointestinal stromal tumor

• Brain tumor, including:

• Diffuse pontine glioma*

• Glioblastoma multiforme

• Glialsarcoma NOTE: *For patients with diffuse pontine glioma, the requirement for histologic verification may be waived

• No known curative therapy

• HLA A*0201 positive by genotyping

PATIENT CHARACTERISTICS:

Age

• Over 2

Performance status

• Karnofsky 60-100% (patients over age 16)

• Lansky 60-100% (patients under age 16)

Life expectancy

• Not specified

Hematopoietic

• WBC greater than 3,000/mm^3

• Absolute neutrophil count greater than 1,500/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic

• AST and ALT less than 2.5 times upper limit of normal (ULN)

• Bilirubin less than 1.5 times ULN

Renal

• Creatinine less than 1.5 times ULN

Cardiovascular

• No clinically significant cardiovascular disease

Pulmonary

• No clinically significant pulmonary disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior hematopoietic stem cell transplantation

• No other concurrent vaccine therapy

• No other concurrent immunotherapy

Chemotherapy

• No prior chemotherapy

• No concurrent chemotherapy

Endocrine therapy

• Concurrent dexamethasone allowed provided patient has been on a decreasing dose for the past 2 weeks and the current dose is the lowest clinically acceptable dose (ideally, less than 9-12 mg/day)

Radiotherapy

• No prior extensive-field radiotherapy that would compromise bone marrow function

• At least 2 weeks since prior local radiotherapy

Surgery

• At least 2 weeks since prior surgery

Other

• At least 2 weeks since prior imatinib mesylate

• No concurrent local anesthetic to administration site of vaccine

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors
• Neoplasms
• Nervous System Neoplasms
• Sarcoma

Intervention

Biological:
• sargramostim

• telomerase: 540-548 peptide vaccine

Locations

Country	Name	City	State
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,