Radiation Therapy and Sargramostim in Treating Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00091052
Recruitment Status : Completed
First Posted : September 8, 2004
Last Update Posted : March 26, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with sargramostim may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects of giving radiation therapy together with sargramostim and to see how well it works in treating patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Biological: sargramostim Radiation: radiation therapy Phase 1 Phase 2

Detailed Description:


  • Determine the safety of contrast-enhanced high-dose radiotherapy administered with sargramostim (GM-CSF) in patients with advanced solid malignancies.
  • Determine immune response in patients treated with this regimen.
  • Determine tumor response in patients treated with this regimen.

OUTLINE: Patients are stratified according to prior therapy (biopsy or simple surgery vs radical surgery, chemotherapy, or radiotherapy).

Patients receive a contrast agent intratumorally followed by a single fraction of kilovoltage radiotherapy. Beginning 24 hours after radiotherapy, patients receive sargramostim (GM-CSF) intratumorally continuously for 1 week and then subcutaneously for 2 weeks. Patients with lung tumors receive GM-CSF by inhalation twice daily for 1 week and then every other week for a total of 3 weeks of drug treatment.

Treatment may repeat in several weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 8 weeks.

PROJECTED ACCRUAL: A total of 47 patients (12 for phase I and 35 for phase II) will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Contrast-Enhanced Radiotherapy With GM-CSF Immune Stimulation - Phase I/II Clinical Center Treatment Trial
Study Start Date : July 2004
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Toxicity as measured by the Southwest Oncology Group Performance Status and Toxicity Criteria on day 1 and in weeks 4, 12, and 20

Secondary Outcome Measures :
  1. Immune and tumor response as measured by reverse transcriptase polymerase chain reaction (RT-PCR) and CT scan on day 1 and in weeks 2, 3, 4, 12, and 20 or weeks 4, 12, and 20

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed solid malignancy

    • Advanced disease
  • Radiotherapy is appropriate treatment (i.e., radio-responsive)

    • No tumors beyond the reach of kilovoltage beam (e.g., > 15 cm beneath the skin)
  • At least 1 lesion accessible to needle localization and catheter placement
  • May be refractory to prior chemotherapy



  • 18 and over

Performance status

  • 0-4

Life expectancy

  • At least 2 months


  • Hemoglobin ≥ 10 g/dL (RBC transfusion allowed)
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3 (transfusion independent)
  • No excessive leukemic blasts
  • No bleeding diathesis


  • PT and PTT ≤ 1.5 times upper limit of normal (ULN)
  • AST or ALT < 2 times ULN
  • Alkaline phosphatase < 2 times ULN


  • Creatinine < 1.5 mg/dL


  • Not pregnant or nursing
  • Negative pregnancy test
  • No contraindication to MRI or CT scan
  • No medical or psychiatric condition that would preclude giving informed consent
  • Able to lie flat for 1 hour
  • No known hypersensitivity to sargramostim (GM-CSF) or any of its components


Biologic therapy

  • Prior biologic therapy allowed
  • No concurrent biologic therapy


  • See Disease Characteristics
  • No concurrent chemotherapy

Endocrine therapy

  • Concurrent hormonal therapy allowed


  • Prior radiotherapy to planned treatment site allowed
  • No other concurrent radiotherapy to planned treatment site


  • Prior surgery allowed


  • More than 14 days since prior radiosensitizers
  • No other concurrent investigational therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00091052

United States, Colorado
Sirius Medicine, LLC
Loveland, Colorado, United States, 80538
Sponsors and Collaborators
Sirius Medicine
Study Chair: Michael D. Weil, MD Sirius Medicine Identifier: NCT00091052     History of Changes
Other Study ID Numbers: CDR0000383147
First Posted: September 8, 2004    Key Record Dates
Last Update Posted: March 26, 2013
Last Verified: May 2006

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific