Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed Over 2 NCI DFCI-02100 NCT00069940

Objectives

1. Determine the feasibility of treatment with telomerase: 540-548 peptide vaccine and sargramostim (GM-CSF) in patients with sarcoma or brain tumor.
2. Determine the safety and tolerability of this regimen in these patients.
3. Determine the frequency of T-cell specific vaccine antigens during and after administration of this regimen in these patients.
4. Determine, preliminarily, the clinical response, if any, of patients treated with this regimen.

Entry Criteria

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

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

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/mm³
• Absolute neutrophil count greater than 1,500/mm³
• Platelet count greater than 100,000/mm³

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

W. Nicholas Haining, BM, BCh, Protocol chair		Ph: 617-632-5293; 866-790-4500

Registry Information
Official Title		A Phase I Study Of Vaccination With Telomerase Peptide Plus GM-CSF
Trial Start Date		2000-12-28
Registered in ClinicalTrials.gov		NCT00069940
Date Submitted to PDQ		2003-03-28
Information Last Verified		2005-02-04
NCI Grant/Contract Number		P30-CA06516

Back to Top