A Phase II Evaluation of DMAP Plus GM-CSF in the Treatment of Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus

Inclusion Criteria

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