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Contrast-Enhanced Radiotherapy With GM-CSF Immune Stimulation - Phase I/II Clinical Center Treatment Trial


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Contrast-Enhanced Radiotherapy With GM-CSF Immune Stimulation - Phase I/II Clinical Center Treatment Trial


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

Yes

Principal Investigator

Michael D. Weil, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sirius Medicine

Authority:

United States: Federal Government

Study ID:

CDR0000383147

NCT ID:

NCT00091052

Start Date:

July 2004

Completion Date:

June 2006

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Sirius Medicine, LLCLoveland, Colorado  80538