Clinical trial · Interventional
Combination Chemotherapy Plus Sargramostim in Treating Patients With Cancer of the Uterus
A Phase II Evaluation of DMAP Plus GM-CSF in the Treatment of Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
- 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus sargramostim in treating patients who have advanced, persistent, or recurrent cancer of the uterus.
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 |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| dacarbazine | Drug | Dacarbazine | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| mitomycin C | Drug | Mitomycin | ALIAS |
| sargramostim | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed primary leiomyosarcoma (LMS) of the uterus * Advanced, persistent, or recurrent disease that is refractory to curative therapy or established treatments * At least 1 unidimensionally measurable target lesion * At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR * At least 10 mm by spiral CT scan * Tumors within a previously irradiated field are designated as non-target lesions * Ineligible for a higher priority Gynecologic Oncology Group protocol (if one exists), including any active phase III protocol for the same population PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * GOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.5 times ULN Other: * No active infection requiring antibiotics * No grade 2 or greater sensory or motor neuropathy * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior cytotoxic chemotherapy for LMS of the uterus Endocrine therapy: * At least 1 week since prior hormonal therapy for LMS of the uterus * Concurrent hormone replacement therapy allowed Radiotherapy: * See Disease Characteristics * Recovered from prior recent radiotherapy Surgery: * Recovered from prior recent surgery Other: * Recovered from other prior recent therapy * No prior cancer treatment that would preclude study therapy
References
Publications (1)
- RESULTLong HJ 3rd, Blessing JA, Sorosky J. Phase II trial of dacarbazine, mitomycin, doxorubicin, and cisplatin with sargramostim in uterine leiomyosarcoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2005 Nov;99(2):339-42. doi: 10.1016/j.ygyno.2005.06.002. Epub 2005 Jul 26. PMID 16051328