Radiation Therapy and Sargramostim in Treating Patients With Advanced Solid Tumors

NCT00091052 | Completed Phase 1

• 3 other identifiers: CDR0000383147SIRIUS-1053285SIRIUS-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (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 Outcomes (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

Interventions

sargramostim BIOLOGICAL

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sirius Medicine: lead

Study Sites (1)

Sirius Medicine, LLC

Loveland, Colorado, 80538, United States

Location

MeSH Terms

Interventions

sargramostim; Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Michael D. Weil, MD

  Sirius Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 7, 2004
• First Posted: September 8, 2004
• Study Start: July 1, 2004
• Study Completion: June 1, 2006
• Last Updated: March 26, 2013

Record last verified: 2006-05

Locations

US (1)