Clinical trial · Interventional
Radiation Therapy and Sargramostim in Treating Patients With Advanced Solid Tumors
Contrast-Enhanced Radiotherapy With GM-CSF Immune Stimulation - Phase I/II Clinical Center Treatment Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available