Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

TERMINATED

Preoperative Thalidomide With Radiation Therapy For Patients With Low-Grade Primary Soft Tissue Sarcoma or Thalidomide With Radiation Therapy and Chemotherapy For Patients With High-Grade or Intermediate-Grade Primary Soft Tissue Sarcoma of the Arm, Leg, or Body Wall

Lead Sponsor:

National Cancer Institute (NCI)

Collaborating Sponsors:

Radiation Therapy Oncology Group

Conditions:

Recurrent Adult Soft Tissue Sarcoma

Stage I Adult Soft Tissue Sarcoma AJCC v7

Eligibility:

All Genders

16+ years

Phase:

PHASE2

Brief Summary

Thalidomide may stop the growth of soft tissue sarcoma by stopping blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as doxorub...

Detailed Description

OBJECTIVES: I. Determine the treatment delivery and toxicity of the combination of thalidomide and radiotherapy in patients with low-grade primary soft tissue sarcoma of the extremity or body wall. ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    June 17 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 5 2013

    Estimated Enrollment :

    23 Patients enrolled

    Trial Details

    Trial ID

    NCT00089544

    Start Date

    June 17 2004

    End Date

    November 5 2013

    Last Update

    April 13 2018

    Active Locations (1)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (1 locations)

    1

    Radiation Therapy Oncology Group

    Philadelphia, Pennsylvania, United States, 19103