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

February 7, 2013 updated by: National Cancer Institute (NCI)

Phase II Trial of Dolastatin-10 in Patients With Previously Untreated Recurrent/Metastatic Sarcoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients receive dolastatin 10 IV over 10 minutes. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: dolastatin 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Study Chair: Margaret von Mehren, MD, Fox Chase Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1999

Primary Completion (Actual)

July 1, 2000

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

August 26, 2004

First Posted (Estimate)

August 27, 2004

Study Record Updates

Last Update Posted (Estimate)

February 8, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

September 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02295
  • FCCC-98019
  • NCI-T98-0026
  • CDR0000066907 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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