Radiation Therapy and Sargramostim in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00091052
First received: September 7, 2004
Last updated: March 25, 2013
Last verified: May 2006
  Purpose

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Biological: sargramostim
Radiation: radiation therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Contrast-Enhanced Radiotherapy With GM-CSF Immune Stimulation - Phase I/II Clinical Center Treatment Trial

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Toxicity as measured by the Southwest Oncology Group Performance Status and Toxicity Criteria on day 1 and in weeks 4, 12, and 20 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Study Start Date: July 2004
Study Completion Date: June 2006
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • 0-4

Life expectancy

  • At least 2 months

Hematopoietic

  • 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

Hepatic

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

Renal

  • Creatinine < 1.5 mg/dL

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior biologic therapy allowed
  • No concurrent biologic therapy

Chemotherapy

  • See Disease Characteristics
  • No concurrent chemotherapy

Endocrine therapy

  • Concurrent hormonal therapy allowed

Radiotherapy

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

Surgery

  • Prior surgery allowed

Other

  • More than 14 days since prior radiosensitizers
  • No other concurrent investigational therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091052

Locations
United States, Colorado
Sirius Medicine, LLC
Loveland, Colorado, United States, 80538
Sponsors and Collaborators
Sirius Medicine
Investigators
Study Chair: Michael D. Weil, MD Sirius Medicine
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00091052     History of Changes
Other Study ID Numbers: CDR0000383147, SIRIUS-1053285, SIRIUS-01
Study First Received: September 7, 2004
Last Updated: March 25, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 31, 2014