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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Ovarian Cancer; Sarcoma	Drug: dolastatin 10	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	37 participants
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
Study Start Date :	April 1999
Actual Primary Completion Date :	July 2000

Arms and Interventions

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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

Outcome Measures

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Eligibility Criteria

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 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