Radiation Therapy and Sargramostim in Treating Patients With Advanced Solid Tumors

NCT ID: NCT00091052

Last Updated: 2013-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2006-06-30

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.

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

sargramostim

Intervention Type: BIOLOGICAL

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sirius Medicine

INDUSTRY

Sponsor Role: lead

Principal Investigators

Michael D. Weil, MD

Role: STUDY_CHAIR

Sirius Medicine

Locations

Sirius Medicine, LLC

Loveland, Colorado, United States

Countries

United States

Other Identifiers

SIRIUS-1053285

Identifier Type: -

Identifier Source: secondary_id

SIRIUS-01

Identifier Type: -

Identifier Source: secondary_id

CDR0000383147

Identifier Type: -

Identifier Source: org_study_id