search
Back to results

Ecteinascidin 743 in Treating Patients With Previously Treated Metastatic Osteosarcoma

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
trabectedin
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring metastatic osteosarcoma, recurrent osteosarcoma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven osteosarcoma previously treated with standard chemotherapy agents (methotrexate, doxorubicin/cisplatin, ifosfamide) Active metastatic disease following chemotherapy At least 1 bidimensionally measurable lesion located in a nonirradiated area CT scan lesion at least 20 mm in at least 1 diameter Clinically measurable lesion at least 20 x 20 mm No symptomatic or known brain or leptomeningeal involvement PATIENT CHARACTERISTICS: Age: 12 and over Performance status: WHO 0-1 Life expectancy: At least 3 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) Alkaline phosphatase no greater than ULN OR Alkaline phosphatase liver fraction and 5'-nucleotidase no greater than ULN AST/ALT less than 2.5 times ULN Albumin greater than 25 g/L No clinically significant liver disease Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 40 mL/min Cardiovascular: No congestive heart failure or angina pectoris even if medically controlled No myocardial infarction within past year No uncontrolled arterial hypertension No arrhythmias Other: Not pregnant or nursing Fertile patients must use effective contraception No history of other malignancy except basal cell carcinoma or carcinoma in situ of the cervix No other serious illness or medical conditions (e.g., history of significant neurological or psychiatric disorders, active infection) No concurrent grapefruit consumption on a regular basis PRIOR CONCURRENT THERAPY: Biologic therapy: Recovered from prior immunotherapy No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered No other concurrent local or systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy No concurrent palliative or primary radiotherapy Surgery: Not specified Other: At least 30 days since other prior investigational drugs No other concurrent investigational drugs No concurrent participation in another clinical trial

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 2, 2000
Last Updated
June 18, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00005625
Brief Title
Ecteinascidin 743 in Treating Patients With Previously Treated Metastatic Osteosarcoma
Official Title
Phase II Study of ET-743 Therapy in Metastatic Osteosarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
September 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients who have previously treated metastatic osteosarcoma.
Detailed Description
OBJECTIVES: I. Determine the partial and complete response rate in patients with previously treated metastatic osteosarcoma when treated with ecteinascidin 743. II. Further characterize the toxicity profile and the pharmacokinetic-pharmacodynamic relationships of this drug in this patient population. OUTLINE: This is a multicenter study. Patients receive ecteinascidin 743 IV over 24 hours. Treatment continues every 6 weeks in the absence of unacceptable toxicity or disease progression for at least 2-6 courses. Patients with a complete response (CR) receive at least 2 additional courses after documented CR. Patients are followed every 3 months until disease progression. All patients are followed until death after disease progression. PROJECTED ACCRUAL: A total of 25-33 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
metastatic osteosarcoma, recurrent osteosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
trabectedin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven osteosarcoma previously treated with standard chemotherapy agents (methotrexate, doxorubicin/cisplatin, ifosfamide) Active metastatic disease following chemotherapy At least 1 bidimensionally measurable lesion located in a nonirradiated area CT scan lesion at least 20 mm in at least 1 diameter Clinically measurable lesion at least 20 x 20 mm No symptomatic or known brain or leptomeningeal involvement PATIENT CHARACTERISTICS: Age: 12 and over Performance status: WHO 0-1 Life expectancy: At least 3 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) Alkaline phosphatase no greater than ULN OR Alkaline phosphatase liver fraction and 5'-nucleotidase no greater than ULN AST/ALT less than 2.5 times ULN Albumin greater than 25 g/L No clinically significant liver disease Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 40 mL/min Cardiovascular: No congestive heart failure or angina pectoris even if medically controlled No myocardial infarction within past year No uncontrolled arterial hypertension No arrhythmias Other: Not pregnant or nursing Fertile patients must use effective contraception No history of other malignancy except basal cell carcinoma or carcinoma in situ of the cervix No other serious illness or medical conditions (e.g., history of significant neurological or psychiatric disorders, active infection) No concurrent grapefruit consumption on a regular basis PRIOR CONCURRENT THERAPY: Biologic therapy: Recovered from prior immunotherapy No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered No other concurrent local or systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy No concurrent palliative or primary radiotherapy Surgery: Not specified Other: At least 30 days since other prior investigational drugs No other concurrent investigational drugs No concurrent participation in another clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Gorlick, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Ecteinascidin 743 in Treating Patients With Previously Treated Metastatic Osteosarcoma

We'll reach out to this number within 24 hrs