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


Phase 1
2 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Gastrointestinal Stromal Tumor, Sarcoma

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Trial Information

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


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.

Inclusion 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

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

Type of Study:

Interventional

Study Design:

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

Principal Investigator

W. Nicholas Haining, BM, BCh

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

03-365

NCT ID:

NCT00069940

Start Date:

December 2000

Completion Date:

August 2008

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Gastrointestinal Stromal Tumor
  • Sarcoma
  • adult glioblastoma
  • stage III adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • adult synovial sarcoma
  • childhood synovial sarcoma
  • childhood leiomyosarcoma
  • adult leiomyosarcoma
  • adult liposarcoma
  • childhood liposarcoma
  • gastrointestinal stromal tumor
  • recurrent childhood brain tumor
  • recurrent adult brain tumor
  • metastatic childhood soft tissue sarcoma
  • recurrent childhood soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult anaplastic astrocytoma
  • adult oligodendroglioma
  • adult anaplastic oligodendroglioma
  • adult diffuse astrocytoma
  • adult mixed glioma
  • adult myxopapillary ependymoma
  • adult anaplastic ependymoma
  • childhood high-grade cerebral astrocytoma
  • recurrent childhood cerebral astrocytoma
  • untreated childhood cerebellar astrocytoma
  • recurrent childhood cerebellar astrocytoma
  • childhood infratentorial ependymoma
  • newly diagnosed childhood ependymoma
  • recurrent childhood ependymoma
  • childhood oligodendroglioma
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Gastrointestinal Stromal Tumors
  • Sarcoma

Name

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115