Ecteinascidin 743 in Treating Patients With Previously Treated Metastatic Osteosarcoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Study Completion Date

2003-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma

NCT00017030

Sarcoma

COMPLETED PHASE2

Ecteinascidin 743 in Treating Patients With Advanced Soft Tissue Sarcoma

NCT00003939

Brain and Central Nervous System Tumors Endometrial Cancer Gastrointestinal Stromal Tumor +3 more

COMPLETED PHASE2

Ecteinascidin 743 in Treating Patients With Malignant Mesothelioma

NCT00027508

Malignant Mesothelioma

TERMINATED PHASE2

Combination Chemotherapy and Surgery in Treating Patients With Newly Diagnosed Metastatic Osteosarcoma

NCT00003776

Sarcoma

COMPLETED PHASE2

2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors

NCT00028821

Refractory Multiple Myeloma Stage III Multiple Myeloma Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sarcoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

trabectedin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No