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

NCT00069940 | Completed Phase 1 DMC

• 2 other identifiers: 03-365P30CA006516
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain and Central Nervous System Tumors; Gastrointestinal Stromal Tumor; Sarcoma

Keywords

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

Interventions

sargramostim BIOLOGICAL

telomerase: 540-548 peptide vaccine BIOLOGICAL

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Gastrointestinal Stromal Tumors; Sarcoma; Glioblastoma; Sarcoma, Synovial; Leiomyosarcoma; Liposarcoma; Brain Neoplasms; Gliosarcoma; Astrocytoma; Oligodendroglioma; Glioma; Ependymoma; Familial ependymoma

Interventions

sargramostim

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Muscle Tissue; Neoplasms, Adipose Tissue; Brain Diseases; Central Nervous System Diseases

Study Officials

• W. Nicholas Haining, BM, BCh

  Dana-Farber Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 3, 2003
• First Posted: October 7, 2003
• Study Start: December 1, 2000
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2008
• Last Updated: December 28, 2010

Record last verified: 2010-12

Locations

US (1)