Trial Search Results

Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma

RATIONALE: Inhaling aerosolized sargramostim before and after surgery may interfere with the growth of tumor cells and shrink the tumor so that it can be removed during surgery. Sargramostim may then kill any tumor cells remaining after surgery. This may be an effective treatment for osteosarcoma that has spread to the lung.

PURPOSE: This phase II trial is studying how well inhaled sargramostim works in treating patients who are undergoing surgery for the first recurrence of osteosarcoma that has spread to the lung.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Children's Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Biological: sargramostim
  • Procedure: conventional surgery

Phase:

Phase 2

Eligibility


DISEASE CHARACTERISTICS:

   - Histologically confirmed osteosarcoma at primary diagnosis

      - Lesions detected in at least 1 lung that are consistent with metastatic disease
      and approachable with thoracotomy

      - No prior recurrence of osteosarcoma

      - No other sites of metastases

   - Resectable pulmonary nodule(s), defined as nodule(s) that are removable without
   performing a pneumonectomy (e.g., nodules immediately adjacent to the main stem
   bronchus or main pulmonary vessels)

   - Prior thoracotomy allowed in patients with imaging consistent with metastatic
   involvement in both lungs provided the lung on which the thoracotomy was performed is
   disease-free

   - No pleural effusion or pleural based nodules

PATIENT CHARACTERISTICS:

Age

   - 39 and under

Performance status

   - Karnofsky 50-100% (patients over 16 years of age)

   - Lansky 50-100% (patients 16 years of age and under)

Life expectancy

   - At least 8 weeks

Hematopoietic

   - Not specified

Hepatic

   - Not specified

Renal

   - Not specified

Pulmonary

   - No evidence of dyspnea at rest

   - No exercise intolerance

   - Pulse oximetry at least 94%

   - Baseline Forced expiratory volume in 1 second (FEV_1) at least 80% of predicted

   - No history of asthma

   - No history of reactive airway disease

   - No history of bronchospasm

Other

   - Willing and able to perform inhalation therapy

   - No medical contraindication to surgical excision

   - Not pregnant or nursing

   - Negative pregnancy test

   - Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

   - No other concurrent immunotherapy

   - No other concurrent immunomodulating agents

Chemotherapy

   - No concurrent anticancer chemotherapy

Endocrine therapy

   - No concurrent steroids by any route

Radiotherapy

   - Not specified

Surgery

   - See Disease Characteristics

   - No concurrent thoracoscopy or video-assisted thoracic surgery

Other

   - No more than 1 prior treatment regimen for osteosarcoma

   - No concurrent participation in another COG therapeutic study

Ages Eligible for Study

N/A - 39 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs
650-723-5535
Not Recruiting