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


Phase 2
18 Years
N/A
Not Enrolling
Female
Sarcoma

Thank you

Trial Information

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


OBJECTIVES:

- Determine the antitumor activity of dacarbazine, mitomycin, doxorubicin, and cisplatin
plus sargramostim (GM-CSF) in patients with advanced, persistent, or recurrent
leiomyosarcoma of the uterus.

- Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: Patients receive dacarbazine IV over 2 hours, followed by mitomycin IV over 2-5
minutes, doxorubicin IV over 2-5 minutes, and cisplatin IV over 2 hours on day 1. Patients
also receive sargramostim (GM-CSF) subcutaneously (SC) once every 12 hours on days -6 to -3
before the first chemotherapy course and then on days 2-15 and 23-26 of all chemotherapy
courses. Courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity. Patients achieving stable disease receive a maximum of 4 courses. Patients
achieving complete or partial response receive a maximum of 6 courses.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 12-43 patients will be accrued for this study within 12-28
months.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Harry J. Long, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000069308

NCT ID:

NCT00033644

Start Date:

March 2002

Completion Date:

Related Keywords:

  • Sarcoma
  • stage IV uterine sarcoma
  • recurrent uterine sarcoma
  • uterine leiomyosarcoma
  • Leiomyosarcoma
  • Uterine Neoplasms
  • Sarcoma

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
University of Colorado Cancer CenterDenver, Colorado  80262
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
Washington University School of MedicineSaint Louis, Missouri  63110
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Tacoma General HospitalTacoma, Washington  98405
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
University of Texas Medical BranchGalveston, Texas  77555-1329
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
Tuft-New England Medical CenterBoston, Massachusetts  02111
Cooper University HospitalCamden, New Jersey  08103
Barrett Cancer CenterCincinnati, Ohio  45267-0502
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182