RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients who have recurrent or metastatic soft tissue sarcoma.

Condition	Treatment or Intervention	Phase
stage IVB adult soft tissue sarcoma recurrent uterine sarcoma recurrent adult soft tissue sarcoma stage IV uterine sarcoma stage IVA adult soft tissue sarcoma ovarian sarcoma	Drug: dolastatin 10	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the response rate in patients with recurrent or metastatic soft tissue sarcomas treated with dolastatin 10.

II. Determine the toxicity of this regimen in this patient population.

PROTOCOL OUTLINE: This is an open label, multicenter study. Patients are stratified according to center, prior therapy, histologic subtype, stage of disease at diagnosis, and current status of disease (recurrent vs metastatic).

Patients receive dolastatin 10 IV over 10 minutes. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 18 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven recurrent or metastatic soft tissue sarcoma; No rhabdomyosarcoma, Ewing's sarcoma, chondrosarcoma, osteogenic sarcoma, mesothelioma, or Kaposi's sarcoma
• Bidimensionally measurable disease other than previously irradiated disease site(s) even if there has been progression within the radiation field; Pulmonary nodule(s) at least 1 x 1 cm
• No brain metastases

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No more than 1 prior chemotherapy regimen in the adjuvant setting; No prior chemotherapy for metastatic disease; At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
• Endocrine therapy: Not specified
• Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy
• Surgery: Recovered from prior surgery

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0 or 1
• Life expectancy: Not specified
• Hematopoietic: Absolute neutrophil count at least 2,000/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin no greater than 1.5 mg/dL; AST and ALT less than 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases present)
• Renal: Creatinine no greater than 1.5 mg/dL
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 3 months after study; No uncontrolled infection; No history of prior malignancy within the past 5 years except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other malignancy in complete remission

Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80262,  United States
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210,  United States
Pennsylvania
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States

Study chairs or principal investigators

Margaret von Mehren,  Study Chair,  Fox Chase Cancer Center   

Study ID Numbers:  CDR0000066907; FCCC-98019; NCI-T98-0026
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003778
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08