Interferon alfa-2b plus Thalidomide

Title: Phase II study of low-dose interferon alfa-2b (Schering-Pough) plus Thalidomide (Celgene) for patients with resected high-risk soft tissue sarcoma and bone sarcoma

Eligibility Requirements:
Histologically confirmed soft tissue sarcoma
Any number of prior systemic chemotherapy allowed
Prior radiation allowed
Must be willing and able to take precautions to prevent pregnancy

Treatment Plan:
Interferon alfa-2b will be administered subcutaneously three times weekly for 60 weeks. Daily thalidomide will be given orally (after the first 12 weeks) for 48 weeks.

Epirubicin

Title: A Phase II study of escalating doses of infusional single agent epirubicin hydrochloride (Ellence) for treatment of advanced soft tissue sarcoma, with correlative studies of cardiac toxicity, tissue analysis for multidrug resistance (MDR), and evaluation of MDR by technetium-99m MIBI

Eligibility Requirements:
Histologically confirmed soft tissue sarcoma that is unresectable, locally advanced or metastatic
Up to 2 prior systemic chemotherapy; anthracyclines will not be allowed
Prior radiation allowed

Treatment Plan:
Epirubicin will be given intravenously over 48 hours every 21 days for 6 cycles in an in-patient setting.

Vaccination Therapy

Title: A pilot study of NY-ESO-I peptide immunization of patients with cancer expressing NY-ESO-I/LAGE antigen

Eligibility Requirements:
Histologically confirmed carcinoma, high-risk, stage II, III, or IV
HLA A2 positive
NY-ESO-1 or LAGE positive tumor tissue
Declined, failed or completed standard therapy
ECOG performance status 0-2

Treatment Plan:
NY-ESO-Ia and NY-ESO-Ib will each be administered by intradermal injection every 2 weeks for a total of 6 vaccinations.

Temodar plus Thalidomide

Title: A phase II study of combination therapy of a protracted oral schedule of temozolomide and thalidomide as first-line or subsequent therapy for patients with metastatic, locally advanced or unresectable leiomyosarcoma.

Eligibility Requirements:
Histologically confirmed leiomyosarcoma that is metastatic, unresectable or locally advanced
Up to 3 prior systemic chemotherapy allowed
Prior radiation therapy or surgery allowed
Measurable disease
Must be willing and able to take precautions to prevent pregnancy

Treatment Plan:
Temozolomide (Temodar) will be given daily at 150mg/m2/day orally for 7 consecutive days every other week. Thalidomide (Thalomid) will be given daily at 200 mg orally for the duration of the study. Study duration is approximately 26 weeks.

Gleevec

Title: Phase II trial of Imatinib mesylate (Gleevec) in patients with soft tissue and bone sarcomas: a multi-disciplinary trial of the North American Sarcoma Study Group of the Connective Tissue Oncology Society.

Eligibility Requirements:
Pathologically verified soft tissue or bone sarcoma that is metastatic or locally advanced
Measurable disease
Prior radiation chemotherapy allowed

Treatment Plan:
Patients will receive Gleevec 400 mg, twice daily or another dose based on pre-study tests. Patients will be evaluated every two months for disease status. Study participation will last as long as patients’ disease is responding or stable and the study drug is tolerated.

Toptecan, Ifosfamide, and Carboplatin

Title: A phase I study of a novel chemotherapeutic regimen: topotecan, ifosfamide, and carboplatin (TIC) in children and young adults with solid tumors

Eligibility Requirements:
=< 45 years of age at study entry
Histologic proof of solid tumor malignancy
Any number of prior systemic chemotherapy allowed
Prior radiation therapy allowed

Treatment Plan:
Chemotherapeutic drugs are given on days 1-3. Topotecan dose will be assigned at study entry; Ifosfamide will be given at 3000 mg/m2; Carboplatin will be given at 3 mg/ml/min. Therapy will continue for a maximum of 3 courses.