Clinical trial NCT00089544 (phase 2, status: terminated)
Conditions: recurrent adult soft tissue sarcoma, stage i adult soft tissue sarcoma ajcc v7, stage ii adult soft tissue sarcoma ajcc v7, stage iii adult soft tissue sarcoma ajcc v7
ICD codes: G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2
Drugs: dacarbazine, doxorubicin hydrochloride, ifosfamide, thalidomide
SMILES: N1C=CN=C1, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, N[C@@H](CCCNC(N)=N)C(O)=O, CC(C)NCC(O)COC1=CC=CC2=C1C=CC=C2
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary soft tissue sarcoma

               -  T2a or T2b disease

               -  Superficial or deep tumor

               -  Grade 1, 2, 3, or 4

               -  Tumor located on the upper extremity (including shoulder), lower extremity
                  (including hip), or trunk

          -  Meets 1 of the following criteria:

               -  Tumor ? 8 cm in maximal diameter and grade 3 or 4 (intermediate or high grade)
                  (cohort A)

               -  Tumor > 5 cm in maximal diameter and grade 1 or 2 (low grade) (cohort B)

          -  Locally recurrent disease allowed provided there has been no prior radiotherapy to the
             primary tumor

          -  No histologically confirmed rhabdomyosarcoma, extraosseous Ewing's primitive
             neuroectodermal tumors, osteosarcoma or chondrosarcoma, Kaposi's sarcoma,
             angiosarcoma, desmoid tumors, or dermatofibrosarcoma protuberans

          -  No overt evidence of lung metastases (CT scan evidence of small incidental lesions
             without histologic diagnosis allowed)

          -  No evidence of other metastases

          -  No sarcoma of the head, neck, intra-abdominal, or retroperitoneal region

          -  Performance status - Zubrod 0-1

          -  At least 2 years

          -  Absolute neutrophil count ? 1,500/mm^3

          -  Platelet count ? 120,000/mm^3

          -  Hemoglobin ? 8.0 g/dL (cohort A)

          -  No known hypercoagulable disorders, such as the following:

               -  APC resistance (factor V Leiden)

               -  Protein S deficiency

               -  Protein C deficiency

               -  Antithrombin III deficiency

               -  Hyperhomocystinemia

               -  Dysplasminogenemia

               -  High plasminogen activator inhibitor

               -  Dysfibrinogenemia

               -  Antiphospholipid syndrome

               -  Thrombocythemia

               -  Dysproteinemia

          -  Fibrin split products < 2 times upper limit of normal (ULN)

          -  Fibrinogen > 200 mg/dL

          -  Bilirubin ? 1.5 mg/dL (1.0 mg/dL for patients with Gilbert's syndrome)

          -  AST and ALT ? 2.0 times ULN

          -  PT and PTT < 1.25 times ULN (except in patients treated with anticoagulants for
             unrelated medical conditions [e.g., atrial fibrillation])

          -  No history of hepatic cirrhosis

          -  Creatinine ? 1.5 mg/dL

          -  Creatinine clearance > 60 mL/min

          -  No atherosclerotic coronary artery disease that required bypass surgery within the
             past year

          -  No uncompensated coronary artery disease by ECG or physical examination

          -  No myocardial infarction within the past 6 months

          -  No severe or unstable angina within the past 6 months

          -  No uncompensated congestive heart failure

          -  No New York Heart Association class II-IV heart disease

          -  No symptomatic peripheral vascular disease

          -  No history of deep vein thrombosis

          -  Cohort A only:

               -  EF ? 50% within the past 6 months

               -  LVEF > 50%

          -  No pulmonary embolus except if caused directly by foreign body implants (e.g., central
             venous catheters or portacaths)

          -  No global neurocognitive symptomatology

          -  No fatigue ? grade 2

          -  No history of uncontrolled seizures or uncontrolled seizure disorder

          -  No sensory neuropathy ? grade 2 except for localized neuropathy due to mechanical
             cause or trauma

          -  No other malignancies within the past 3 years except non-invasive malignancies (e.g.,
             carcinoma in situ of the cervix, breast, or oral cavity) or squamous or basal cell
             skin cancer

          -  No history of uncontrolled myxedema

          -  No hypothyroidism ? grade 3

          -  No active uncontrolled bacterial, viral, or fungal infection

          -  No other significant illness that would preclude surgery

          -  No other major illness or psychiatric impairment that would preclude study therapy

          -  No known AIDS

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use 2 effective barrier methods of contraception for 4 weeks
             before, during, and for at least 4 weeks after study treatment

          -  No prior thalidomide

          -  No prior biologic therapy for this tumor

          -  No prior chemotherapy for this tumor

          -  See Disease Characteristics

          -  No prior radiotherapy for this tumor

          -  See Cardiovascular

          -  No other concurrent investigational drugs

          -  No concurrent sedating drugs

          -  No concurrent illegal sedating "recreational" drugs

          -  No concurrent alcohol intake of more than 1 drink per day