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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00003778

First Posted: August 27, 2004

Last Update Posted: February 8, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

National Cancer Institute (NCI)

Purpose

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.

Condition	Intervention	Phase
Ovarian Cancer Sarcoma	Drug: dolastatin 10	Phase 2


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Phase II Trial of Dolastatin-10 in Patients With Previously Untreated Recurrent/Metastatic Sarcoma

Resource links provided by NLM:

Genetics Home Reference related topics: ovarian cancer

MedlinePlus related topics: Soft Tissue Sarcoma

Genetic and Rare Diseases Information Center resources: Soft Tissue Sarcoma Ovarian Cancer Uterine Sarcoma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):


Enrollment:	37
Study Start Date:	April 1999
Primary Completion Date:	July 2000 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003778

Locations


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

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators


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

More Information


Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003778 History of Changes
Other Study ID Numbers:	NCI-2012-02295 FCCC-98019 NCI-T98-0026 CDR0000066907 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted:	November 1, 1999
First Posted:	August 27, 2004
Last Update Posted:	February 8, 2013
Last Verified:	September 2000

Keywords provided by National Cancer Institute (NCI):


recurrent adult soft tissue sarcoma stage IV uterine sarcoma recurrent uterine sarcoma ovarian sarcoma stage IV adult soft tissue sarcoma

Additional relevant MeSH terms:


Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Dolastatin 10	Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action

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