Dolastatin 10 in Treating Patients With Recurrent or Metastatic Soft Tissue Sarcoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase II trial to study the effectiveness of dolastatin 10 in treating patients who have recurrent or metastatic soft tissue sarcoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Dolastatin 10

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

PATIENT CHARACTERISTICS:

• Age: 18 and over

• Performance status: ECOG 0 or 1

• Absolute neutrophil count at least 2,000/mm3

• Platelet count at least 100,000/mm3

• 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)

• Creatinine no greater than 1.5 mg/dL

• 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

PRIOR CONCURRENT THERAPY:

• 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)

• At least 4 weeks since prior radiotherapy

• Recovered from prior surgery