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

NCT ID: NCT00003778

Last Updated: 2013-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-04-30

Brief 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.

Detailed Description

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.

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.

Conditions

Ovarian Cancer; Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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

Group Type: EXPERIMENTAL

dolastatin 10

Intervention Type: DRUG

Interventions

dolastatin 10

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret von Mehren, MD

Role: STUDY_CHAIR

Fox Chase Cancer Center

Locations

University of Colorado Cancer Center

Denver, Colorado, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

FCCC-98019

Identifier Type: -

Identifier Source: secondary_id

NCI-T98-0026

Identifier Type: -

Identifier Source: secondary_id

CDR0000066907

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02295

Identifier Type: -

Identifier Source: org_study_id