Radiation Therapy and Sargramostim in Treating Patients With Advanced Solid Tumors - Full Text View

Sponsored by:	Sirius Medicine
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00091052

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	Drug: sargramostim Procedure: radiation therapy	Phase I Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Sargramostim Granulocyte-macrophage colony-stimulating factor

U.S. FDA Resources

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

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

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

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

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000383147, SIRIUS-1053285, SIRIUS-01
Study First Received:	September 7, 2004
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00091052
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 January 14, 2009